- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01574079
Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
September 4, 2014 updated by: Lisa J Barnes, University of Mississippi Medical Center
Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center - University Rehabilitation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Physical Therapy
The control group will receive traditional physical therapy interventions directed at neuromuscular rehabilitation.
|
Traditional physical therapy includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
|
|
Experimental: Physical Therapy plus Mirror Therapy
The mirror therapy will entail 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Independence Measure - Locomotor Score
Time Frame: measured at admission and discharge from rehab estimated length of stay 14 days
|
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.
|
measured at admission and discharge from rehab estimated length of stay 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go
Time Frame: Measured at admission and discharge with estimated length of stay 14 days
|
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.
|
Measured at admission and discharge with estimated length of stay 14 days
|
|
Stroke Rehabilitation Assessment of Movement
Time Frame: measured at admission and discharge with estimated length of stay 14 days
|
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.
|
measured at admission and discharge with estimated length of stay 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa J Barnes, PT DPT, University of Mississippi Medical Center
- Study Director: Keri H McCullough, DPT, University of Mississippi Medical Center - University Rehabilitation
- Study Director: Kim C Wilcox, PT MsPT PhD, University of Mississippi Medical Center - Director of Neurologic Residency Program
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
January 30, 2012
First Submitted That Met QC Criteria
April 9, 2012
First Posted (Estimate)
April 10, 2012
Study Record Updates
Last Update Posted (Estimate)
September 11, 2014
Last Update Submitted That Met QC Criteria
September 4, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-0244
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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