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Trial record 62 of 346 for:    sprains and strains

Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains

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ClinicalTrials.gov Identifier: NCT01853462
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Lazaros Lazarou, Aristotle University Of Thessaloniki

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Ankle Sprains
Interventions Other: PNF training
Other: Balance training
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
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PNF training

proprioceptive neuromuscular facilitation exercise program: Ten individual sessions (50-60min per session) of PNF training, supervised by a physical therapist

Balance training

balance exercise program: Ten individual sessions (50-60min per session) of balance training, supervised by a physical therapist

Period Title: Overall Study
Started 11 11
Completed 10 10
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance Total
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PNF training

proprioceptive neuromuscular facilitation exercise program: Ten individual sessions (50-60min per session) of PNF training, supervised by a physical therapist

Balance training

balance exercise program: Ten individual sessions (50-60min per session) of balance training, supervised by a physical therapist

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
21.8  (3.8) 21.5  (1.8) 21.7  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
7
  70.0%
7
  70.0%
14
  70.0%
Male
3
  30.0%
3
  30.0%
6
  30.0%
1.Primary Outcome
Title Ankle Functional Stability, Via the Single-leg Hop for Distance Test
Hide Description Participants hopped, using the sprained leg, as far forward as possible, and remained in the landing position for 2sec. Three trials were performed, and the mean hopping distance was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Centimeters
Baseline 65.6  (17.0) 82.8  (19.5)
Follow-up 1 100.3  (17.0) 101.4  (29.8)
Follow-up 2 77.0  (17.6) 110.0  (30.5)
2.Primary Outcome
Title Ankle Functional Stability, Via the Single-leg Hops for Time Test
Hide Description Participants hopped, using the sprained leg, as fast as possible, a six-meter distance. Three trials were performed, and the mean hopping time was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Seconds
Baseline 2.9  (0.6) 3.3  (0.4)
Follow-up 1 2.1  (0.2) 2.7  (0.4)
Follow-up 2 2.1  (0.3) 2.2  (0.4)
3.Primary Outcome
Title Endurance of Ankle Dorsiflexor Muscles
Hide Description

The rising on heel test was used, and participants rose on the heel of the sprained leg, as many times as possible.

Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises.

Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: points on a scale
Baseline
0
(0 to 10)
5
(0 to 10)
Follow-up 1
10
(5 to 10)
10
(5 to 10)
Follow-up 2
7.5
(0 to 10)
10
(5 to 10)
4.Primary Outcome
Title Endurance of Ankle Plantar Flexor Muscles
Hide Description The rising on toes test was used, and participants rose on the toes of the sprained leg, as many times as possible. Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: points on a scale
Baseline
0
(0 to 0)
0
(0 to 0)
Follow-up 1
5
(0 to 10)
7.5
(0 to 10)
Follow-up 2
7.5
(0 to 10)
7.5
(0 to 10)
5.Secondary Outcome
Title Anterior-posterior Stability Index
Hide Description The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The anterior-posterior stability index corresponded to the variance of foot platform displacement in the sagittal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 2.6  (0.6) 3.1  (0.6)
Follow-up 1 2.6  (0.3) 3.0  (0.7)
Follow-up 2 2.5  (0.4) 3.1  (0.7)
6.Secondary Outcome
Title Medial-lateral Stability Index
Hide Description The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The medial-lateral stability index corresponded to the variance of foot platform displacement in the frontal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 1.9  (0.5) 1.9  (0.4)
Follow-up 1 1.7  (0.5) 2.0  (0.5)
Follow-up 2 1.6  (0.4) 1.5  (0.3)
7.Secondary Outcome
Title Overall Stability Index
Hide Description The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The overall stability index corresponded to the variance of foot platform overall displacement, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 3.1  (0.7) 3.6  (0.8)
Follow-up 1 3.0  (0.6) 3.4  (0.5)
Follow-up 2 2.9  (0.6) 3.4  (0.6)
8.Secondary Outcome
Title Ankle Dorsiflexion Range of Motion
Hide Description Assessement was performed with a goniometer. Participants actively dorsiflexed the sprained ankle, while being in long sitting, on a physical therapy table. The mean score of three measurements was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 7  (3) 8  (2)
Follow-up 1 13  (3) 15  (2)
Follow-up 2 15  (2) 15  (1)
9.Secondary Outcome
Title Pain Sensation
Hide Description The main component of the Greek version of the short form of McGill Pain Questionnaire (GR-SFMPQ) was used for the assessment of pain sensation of the sprained ankle. This consists of 15 descriptive adjectives for the pain sensation (11 sensory and 4 affective), which are self-rated according to their intensity level on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total rating score (minimum = 0, maximum = 45) of the main component of the GR-SFMPQ was used for data analysis, with higher values representing a worse pain sensation.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: Total score of scales
Baseline
7
(1 to 12)
6
(2 to 10)
Follow-up 1
0
(0 to 2)
0
(0 to 2)
Follow-up 2
3.5
(0 to 10)
0.5
(0 to 1)
10.Secondary Outcome
Title Pain Intensity During the Week Before Testing
Hide Description The second component of the Greek version of the short form of McGill Pain Questionnaire, which is a visual analogue scale (VAS), was used for the assessment. The VAS is a horizontal 10-cm line with clearly defined boundaries: 0 cm = 'No pain' and 10.0 cm = 'worst possible pain'. partipants made a mark on the line at the point that better described the average pain intensity for their sprained ankle, during the week before testing. The distance marked from the 'no pain' point was measured in mm and was used for data analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Points on a scale
Baseline 2.0  (1.6) 2.8  (2.1)
Follow-up 1 0.4  (0.4) 1.1  (1.3)
Follow-up 2 1.3  (1.0) 0.5  (0.7)
11.Secondary Outcome
Title Present Pain
Hide Description The third component of the Greek version of the short form of McGill Pain Questionnaire, which is a 6-point verbal rating scale, was used for the assessment. Participants noted what word at the time completing the questionnaire would best describe their pain sensation for the sprained ankle (scoring: no pain = 0, mild = 1, discomforting = 2, distressing = 3, horrible = 4, excruciating = 5). The score corresponding to the noted word was used for data analysis, with higher values representing a worse pain sensation.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: Points on a scale
Baseline
1
(0 to 2)
1
(0 to 2)
Follow-up 1
0
(0 to 1)
0
(0 to 1)
Follow-up 2
1
(0 to 2)
0
(0 to 1)
12.Secondary Outcome
Title Ankle Joint Sense for 10° Dorsiflexion
Hide Description The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 10° dorsiflexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 4  (2) 6  (4)
Follow-up 1 1  (1) 3  (3)
Follow-up 2 5  (3) 4  (2)
13.Secondary Outcome
Title Ankle Joint Sense for 15° Plantar Flexion
Hide Description The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 15° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 10  (4) 9  (4)
Follow-up 1 7  (3) 5  (1)
Follow-up 2 8  (3) 5  (1)
14.Secondary Outcome
Title Ankle Joint Sense for 30° Plantar Flexion
Hide Description The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 30° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Degrees
Baseline 7  (6) 4  (3)
Follow-up 1 4  (2) 3  (1)
Follow-up 2 5  (2) 3  (2)
15.Secondary Outcome
Title Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 35.8  (8.2) 31.7  (6.8)
Follow-up 1 30.7  (7.3) 32.3  (8.6)
Follow-up 2 30.8  (5.8) 30.3  (7.3)
16.Secondary Outcome
Title Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 20.3  (4.2) 22.7  (5.9)
Follow-up 1 19.0  (5.4) 21.4  (5.5)
Follow-up 2 19.4  (4.1) 22.1  (5.5)
17.Secondary Outcome
Title Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 31.5  (13.8) 47.8  (23.6)
Follow-up 1 46.1  (11.3) 80.6  (31.4)
Follow-up 2 53.5  (14.7) 65.5  (25.5)
18.Secondary Outcome
Title Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 17.4  (4.6) 26.0  (15.5)
Follow up 1 25.0  (13.4) 40.2  (12.1)
Follow up 2 25.0  (8.6) 38.1  (12.4)
19.Secondary Outcome
Title Peak Torque of Foot Evertor Muscles at 30°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 11.9  (1.8) 13.6  (2.5)
Follow up 1 13.0  (3.8) 14.5  (2.0)
Follow up 2 13.9  (4.0) 18.8  (2.3)
20.Secondary Outcome
Title Peak Torque of Foot Evertor Muscles at 120°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 8.0  (1.4) 9.1  (1.5)
Follow up 1 10.5  (2.3) 8.6  (2.2)
Follow up 2 10.5  (3.1) 13.0  (3.0)
21.Secondary Outcome
Title Peak Torque of Foot Invertor Muscles at 30°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 10.1  (3.2) 12.2  (3.8)
Follow up 1 12.6  (5.6) 18.6  (3.7)
Follow up 2 26.2  (6.5) 29.6  (9.9)
22.Secondary Outcome
Title Peak Torque of Foot Invertor Muscles at 120°/Sec Speed
Hide Description The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Newton metres
Baseline 6.7  (2.3) 9.3  (3.5)
Follow up 1 9.5  (3.2) 12.0  (3.7)
Follow up 2 21.6  (5.7) 27.7  (8.9)
23.Secondary Outcome
Title Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 1.02  (0.25) 0.88  (0.10)
Follow up 1 0.90  (0.24) 1.03  (0.10)
Follow up 2 1.02  (0.27) 0.92  (0.13)
24.Secondary Outcome
Title Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 0.99  (0.13) 0.88  (0.23)
Follow up 1 0.98  (0.17) 0.85  (0.15)
Follow up 2 1.02  (0.21) 0.83  (0.13)
25.Secondary Outcome
Title Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 0.78  (0.21) 0.64  (0.09)
Follow up 1 0.60  (0.16) 0.76  (0.12)
Follow up 2 0.61  (0.15) 0.68  (0.14)
26.Secondary Outcome
Title Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
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[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
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Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 0.82  (0.28) 0.61  (0.15)
Follow up 1 0.68  (0.21) 0.71  (0.10)
Follow up 2 0.71  (0.16) 0.83  (0.12)
27.Secondary Outcome
Title Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation(PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 0.89  (0.24) 0.70  (0.22)
Follow up 1 0.78  (0.22) 0.68  (0.12)
Follow up 2 0.92  (0.17) 0.63  (0.16)
28.Secondary Outcome
Title Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 0.95  (0.34) 0.75  (0.15)
Follow up 1 0.67  (0.26) 0.70  (0.15)
Follow up 2 0.87  (0.43) 0.74  (0.16)
29.Secondary Outcome
Title Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 0.40  (0.11) 0.39  (0.10)
Follow up 1 0.32  (0.13) 0.40  (0.18)
Follow up 2 0.54  (0.16) 0.31  (0.15)
30.Secondary Outcome
Title Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed
Hide Description Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Time Frame Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Proportion
Baseline 0.43  (0.12) 0.44  (0.15)
Follow up 1 0.45  (0.16) 0.36  (0.14)
Follow up 2 0.38  (0.14) 0.32  (0.17)
31.Secondary Outcome
Title Participants With Recurrent Ankle Sprain
Hide Description [Not Specified]
Time Frame Twelve months after the completion of training
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description:
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Supervised Balance Training
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
0
   0.0%
Time Frame Adverse event data (not including serious) were collected during and after the completion of each individual training session
Adverse Event Reporting Description The rating of perceived exertion was measured with the use of the Category Ratio-10 Borg Rating Scale. In addition, pain intensity was measured via a Numeric (0-10) Pain Rating Scale. For the measurements performed during training, participants who scored ≥4 ('somewhat strong' perceived exertion or more) in the Category Ratio-10 Borg Rating Scale or ≥5 ('moderate' pain or more) in the Numeric (0-10) Pain Rating Scale were free to interrupt training for that particular session.
 
Arm/Group Title Proprioceptive Neuromuscular Facilitation (PNF) Balance
Hide Arm/Group Description Supervised Proprioceptive Neuromuscular Facilitation (PNF) training Supervised Balance Training
All-Cause Mortality
Proprioceptive Neuromuscular Facilitation (PNF) Balance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Proprioceptive Neuromuscular Facilitation (PNF) Balance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Proprioceptive Neuromuscular Facilitation (PNF) Balance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lazaros Lazarou
Organization: Aristotle University of Thessaloniki
Responsible Party: Lazaros Lazarou, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01853462     History of Changes
Other Study ID Numbers: PNF-123-BAL-SPR
First Submitted: May 9, 2013
First Posted: May 15, 2013
Results First Submitted: October 3, 2016
Results First Posted: November 1, 2018
Last Update Posted: November 1, 2018