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Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke

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ClinicalTrials.gov Identifier: NCT01574079
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Lisa J Barnes, University of Mississippi Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Stroke
Interventions Other: Traditional Physical Therapy
Other: Physical Therapy plus Mirror Therapy
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Traditional Physical Therapy Physical Therapy Plus Mirror Therapy
Hide Arm/Group Description The control group will receive traditional physical therapy which includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education. The treatment group will receive traditional physical therapy with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
Period Title: Overall Study
Started 18 15
Completed 17 13
Not Completed 1 2
Reason Not Completed
Physician Decision             0             2
Lost to Follow-up             1             0
Arm/Group Title Traditional Physical Therapy Physical Therapy Plus Mirror Therapy Total
Hide Arm/Group Description The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education. The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities. Total of all reporting groups
Overall Number of Baseline Participants 18 15 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  83.3%
13
  86.7%
28
  84.8%
>=65 years
3
  16.7%
2
  13.3%
5
  15.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 15 participants 33 participants
53.47  (11.94) 48.85  (15.53) 51.47  (13.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 33 participants
Female
8
  44.4%
4
  26.7%
12
  36.4%
Male
10
  55.6%
11
  73.3%
21
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 15 participants 33 participants
18 15 33
1.Primary Outcome
Title Functional Independence Measure - Locomotor Score
Hide Description The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence.
Time Frame measured at admission and discharge from rehab estimated length of stay 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Thirty-three participants enrolled in the study with 3 dropping out before completion. Two of these were due to medical issues, and one was discharged unexpectedly
Arm/Group Title Control Group Treatment Group
Hide Arm/Group Description:
The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
Overall Number of Participants Analyzed 17 13
Mean (Standard Deviation)
Unit of Measure: outcome score
FIM locomotor score on admission 1.65  (1.06) 1.33  (0.65)
FIM locomotor score at discharge 3.82  (1.38) 4.25  (0.62)
2.Secondary Outcome
Title Timed Up and Go
Hide Description The Timed Up and Go (TUG) is used to assess balance and gait, and to estimate fall risks in patients with deficits. The participant rises from a seated position in a chair, walks 3 meters, turns around, returns to the chair, and sits down. The test is measured in seconds, with a lower number indicating a higher level of independence and the least risk for falls.
Time Frame Measured at admission and discharge with estimated length of stay 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Treatment Group
Hide Arm/Group Description:
The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
Overall Number of Participants Analyzed 17 13
Mean (Standard Deviation)
Unit of Measure: seconds
TUG on admission (in seconds) 100.69  (53.42) 97.75  (47.69)
TUG at discharge (in seconds) 50.6  (34.88) 49.25  (15.96)
3.Secondary Outcome
Title Stroke Rehabilitation Assessment of Movement
Hide Description The Stroke Rehabilitation Assessment of Movement (STREAM)is designed to measure mobility and motor ability after stroke. There are three subscales with 10 items each assessing the upper extremity, lower extremity, and basic mobility. Only the lower extremity and basic mobility items were used in this study. The lower extremity scores ranged from 0 - 18 with higher scores indicating a higher level of motor control. The basic mobility scores ranged from 0 - 30 with high numbers indicating a higher level of functional mobility.
Time Frame measured at admission and discharge with estimated length of stay 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Treatment Group
Hide Arm/Group Description:
The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
Overall Number of Participants Analyzed 17 13
Mean (Standard Deviation)
Unit of Measure: outcome score
STREAM LE admission 8.18  (4.97) 5.33  (1.92)
STREAM LE discharge 12.41  (5.33) 8.58  (2.61)
STREAM mobility on admission 6.29  (7.65) 5.92  (4.42)
STREAM mobility at discharge 16.47  (9.86) 14.67  (6.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Treatment Group
Hide Arm/Group Description The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education. The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
All-Cause Mortality
Control Group Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Control Group Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principle investigator
Organization: University of Mississippi Medical Center
Phone: 601-984-6369
EMail: lbarnes@umc.edu
Layout table for additonal information
Responsible Party: Lisa J Barnes, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01574079    
Other Study ID Numbers: 2010-0244
First Submitted: January 30, 2012
First Posted: April 10, 2012
Results First Submitted: June 25, 2013
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014