Back to resultsEffect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Physical Therapy
Physical Therapy plus Mirror Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- lower extremity Brunnstrom stage 2,
- lower extremity modified ashworth < 3,
- has the ability to follow 3-step command in English,
- has only unilateral involvement.
Exclusion Criteria:
- lower extremity Brunnstrom stage 1,
- lower extremity modified ashworth 3 or higher,
- history of prior stroke,
- Passive Range of Motion limitation of hip and or knee flexion < 90,
- has visual deficits which prevent participation.
Sites / Locations
- University of Mississippi Medical Center - University Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional Physical Therapy
Physical Therapy plus Mirror Therapy
Arm Description
The control group will receive traditional physical therapy interventions directed at neuromuscular rehabilitation.
The mirror therapy will entail 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion.
Outcomes
Primary Outcome Measures
Functional Independence Measure - Locomotor Score
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.
Secondary Outcome Measures
Timed Up and Go
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.
Stroke Rehabilitation Assessment of Movement
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.
Full Information
NCT ID
NCT01574079
First Posted
January 30, 2012
Last Updated
September 4, 2014
Sponsor
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01574079
Brief Title
Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
Official Title
Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.
Detailed Description
Using a mirrored image of the uninvolved extremity superimposed upon the involved extremity during exercise may facilitate improved motor control in patients after stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Physical Therapy
Arm Type
Active Comparator
Arm Description
The control group will receive traditional physical therapy interventions directed at neuromuscular rehabilitation.
Arm Title
Physical Therapy plus Mirror Therapy
Arm Type
Experimental
Arm Description
The mirror therapy will entail 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion.
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy
Intervention Description
Traditional physical therapy includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
Intervention Type
Other
Intervention Name(s)
Physical Therapy plus Mirror Therapy
Intervention Description
The treatment group will receive traditional physical therapy intervention as described in the control group with the addition of mirror therapy. The participant will attempt to perform the flexion 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.
Primary Outcome Measure Information:
Title
Functional Independence Measure - Locomotor Score
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
Secondary Outcome Measure Information:
Title
Timed Up and Go
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
Title
Stroke Rehabilitation Assessment of Movement
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lower extremity Brunnstrom stage 2,
lower extremity modified ashworth < 3,
has the ability to follow 3-step command in English,
has only unilateral involvement.
Exclusion Criteria:
lower extremity Brunnstrom stage 1,
lower extremity modified ashworth 3 or higher,
history of prior stroke,
Passive Range of Motion limitation of hip and or knee flexion < 90,
has visual deficits which prevent participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa J Barnes, PT DPT
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keri H McCullough, DPT
Organizational Affiliation
University of Mississippi Medical Center - University Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kim C Wilcox, PT MsPT PhD
Organizational Affiliation
University of Mississippi Medical Center - Director of Neurologic Residency Program
Official's Role
Study Director
Facility Information:
Facility Name
University of Mississippi Medical Center - University Rehabilitation
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
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Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
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