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Balance Training vs. Balance Training w/ STARS

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ClinicalTrials.gov Identifier: NCT01790581
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : December 24, 2014
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Mid-Atlantic Athletic Trainers' Association
Information provided by (Responsible Party):
University of North Carolina, Charlotte

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ankle (Ligaments); Instability (Old Injury)
Interventions Behavioral: Balance Training
Behavioral: STARS
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Balance Training Balance Training w/ STARS
Hide Arm/Group Description Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).

Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised sessions. Exercises and repetitions per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).

STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.

Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Balance Training Balance Training w/ STARS Total
Hide Arm/Group Description Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).

Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).

STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
21.3  (1.7) 21.8  (2.5) 21.5  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
8
  66.7%
6
  50.0%
14
  58.3%
Male
4
  33.3%
6
  50.0%
10
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Foot and Ankle Ability Measure   [1] 
Mean (Standard Deviation)
Unit of measure:  % of total questionnaire points
Number Analyzed 12 participants 12 participants 24 participants
87.1  (8.1) 86.5  (5.6) 86.8  (6.9)
[1]
Measure Description: The Foot and Ankle Ability Measure (FAAM) contains 21 activity related items (max score of 84). Lower percentages (patient’s score divided by max score) represent greater disability. The FAAM has been found to be reliable and precise (r=0.89, SEM= 2.1) in people with CAI.
Foot and Ankle Ability Measure-Sport   [1] 
Mean (Standard Deviation)
Unit of measure:  % of total questionnaire points
Number Analyzed 12 participants 12 participants 24 participants
66.2  (12.0) 72.2  (10.4) 68.9  (11.4)
[1]
Measure Description: The Foot and Ankle Ability Measure- Sports (FAAM-S) contains 8 activity related items (max score of 32). Lower percentages (patient’s score divided by max score) represent greater disability. The FAAM-S has been found to be reliable and precise (r=0.87, SEM= 4.5) in people with CAI.
Star Excursion Balance Test- Anterior Reach   [1] 
Mean (Standard Deviation)
Unit of measure:  % of leg length
Number Analyzed 12 participants 12 participants 24 participants
68.7  (8.3) 66.2  (6.9) 67.5  (7.6)
[1]
Measure Description: To conduct the reach trials, participants placed the test limb in a grid center and kept their hands on their hips. Participants then reached as far as possible in the test direction with the non-test limb. Reach distance was defined as the farthest point that an individual could touch without accepting weight and maintaining balance through the return to a bilateral stance. Reach distance was normalized to the participant’s leg length (distance from the anterior superior iliac spine to the ipsilateral medial malleolus). This is a reliable measure of dynamic balance (ICC2,1=0.85-0.96).
Star Excursion Balance Test- Posteriomedial Reach   [1] 
Mean (Standard Deviation)
Unit of measure:  % of leg length
Number Analyzed 12 participants 12 participants 24 participants
79.5  (9.3) 78.5  (6.7) 79.0  (8.0)
[1]
Measure Description: To conduct the reach trials, participants placed the test limb in a grid center and kept their hands on their hips. Participants then reached as far as possible in the test direction with the non-test limb. Reach distance was defined as the farthest point that an individual could touch without accepting weight and maintaining balance through the return to a bilateral stance. Reach distance was normalized to the participant’s leg length (distance from the anterior superior iliac spine to the ipsilateral medial malleolus). This is a reliable measure of dynamic balance (ICC2,1=0.85-0.96).
Star Excursion Balance Test- Posteriolateral Reach   [1] 
Mean (Standard Deviation)
Unit of measure:  % of leg length
Number Analyzed 12 participants 12 participants 24 participants
75.7  (12.4) 72.3  (11.3) 74.0  (11.7)
[1]
Measure Description: To conduct the reach trials, participants placed the test limb in a grid center and kept their hands on their hips. Participants then reached as far as possible in the test direction with the non-test limb. Reach distance was defined as the farthest point that an individual could touch without accepting weight and maintaining balance through the return to a bilateral stance. Reach distance was normalized to the participant’s leg length (distance from the anterior superior iliac spine to the ipsilateral medial malleolus). This is a reliable measure of dynamic balance (ICC2,1=0.85-0.96).
1.Primary Outcome
Title Balance
Hide Description Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
Time Frame Balance at 1-day post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Balance Training Balance Training w/ STARS
Hide Arm/Group Description:
Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).

Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).

STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: % of leg length
Star Excursion Balance Test: Anterior Reach 68.7  (8.3) 66.2  (6.9)
Star Excursion Balance Test: Posteriomedial Reach 87.7  (9.0) 85.5  (8.4)
Star Excursion Balance Test: Posteriolateral Reach 83.9  (10.8) 81.0  (7.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balance Training, Balance Training w/ STARS
Comments This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .904
Comments [Not Specified]
Method MANOVA
Comments [Not Specified]
2.Primary Outcome
Title Self-assessed Disability
Hide Description 2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient’s score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.
Time Frame Disability to 1-day post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Balance Training Balance Training w/ STARS
Hide Arm/Group Description:
Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).

Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).

STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: % of total questionnaire points
Foot and Ankle Ability Measure 89.7  (5.3) 88.2  (7.9)
Foot and Ankle Ability Measure- Sport 76.4  (12.4) 77.4  (9.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balance Training, Balance Training w/ STARS
Comments This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .5
Comments [Not Specified]
Method MANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Balance
Hide Description Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
Time Frame Change from baseline balance at 1-week post intervention
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Self-assessed Disability
Hide Description 2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
Time Frame Change from baseline disability at 1-week post intervention
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Self-assessed Disability
Hide Description 3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
Time Frame Change from baseline disability at 1-month post intervention
Outcome Measure Data Not Reported
Time Frame During 4 week intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Balance Training Balance Training w/ STARS
Hide Arm/Group Description Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).

Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).

STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.

All-Cause Mortality
Balance Training Balance Training w/ STARS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Balance Training Balance Training w/ STARS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Balance Training Balance Training w/ STARS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (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
Layout table for Results Point of Contact information
Name/Title: Erik Wikstrom
Organization: UNC Charlotte
Phone: 704-778-5784
EMail: ewikstrom@uncc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Charlotte
ClinicalTrials.gov Identifier: NCT01790581     History of Changes
Other Study ID Numbers: UNCC12-09-16
First Submitted: February 8, 2013
First Posted: February 13, 2013
Results First Submitted: December 4, 2014
Results First Posted: December 24, 2014
Last Update Posted: July 11, 2017