Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

Study Overview
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Brief Summary
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This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place at the institute. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

Detailed Description
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The study necessitated patients with chronic stroke to walk on a treadmill while viewing a reflection of their non-affected limb in a mirror. There was also a placebo group and these patients walked on the treadmill and viewed a mirror in an altered position. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 30 participants were recruited. Patients attended the study for 30 minutes per day, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three month followup assessment. All assessments were carried out by a Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb motor function, muscle tone, walking speed and endurance.

Official Title
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Mirror Therapy and Treadmill Training for Patients With Chronic Stroke: A Pilot Randomised Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Mirror Therapy
* Device: Placebo Mirror Therapy
* Device: Treadmill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic stroke (greater than or equal to 6 months post stroke) with lower limb heimiparesis. Ambulatory with/without walking aid. Discharged from formal rehabilitation. A Mini Mental State Examination >/= 24. Exclusion Criteria: Younger than 18 years Any additional illness that may prevent treadmill walking A Mini Mental State Examination < 24.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot Randomised Placebo Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirror Therapy & Treadmill Training<br>Mirror Therapy: Participants view a mirror reflection of their non-affected limb which is placed in their mid-sagittal plane for 30 mins per day, 3 days per week, for four weeks. Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. | Device: Mirror Therapy<br>* Participants view the reflective side of a simple mirror which is placed in their mid-sagittal plane to view a mirror reflection of their non-affected limb for 30 mins per day, 3 days per week, for four weeks.<br>* Other names: Mirror Designed by IT Sligo.;Device: Treadmill<br>* Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.<br>* Other names: Variable speed Treadmill.;|
| Placebo Comparator: Placebo Mirror & Treadmill Training<br>Placebo Mirror Therapy: Participants view a mirror which is placed forward/ahead of them in their mid-sagittal plane, and cannot see a reflection of any lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks. Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. | Device: Placebo Mirror Therapy<br>* Placebo Mirror Therapy: Participants view the reflective side of a simple mirror which is placed forward/ahead of them in their mid-sagittal plane, and thus cannot see a reflection of either lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks. Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.<br>* Other names: Mirror Designed by IT Sligo.;Device: Treadmill<br>* Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.<br>* Other names: Variable speed Treadmill.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ten Metre Walk Test | Walking velocity measure. Lower times indicate an increased walking velocity. | 5 mins. | 
| Six Minute Walk Test | Walking endurance measure. Larger distance indicates an improved walking endurance ability. | 10 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension). | 10 minutes | 
| Fugl-Meyer Assessment-Lower extremity | Motor function outcome. Range 0 (Unable to do any functional Task) to 34 (Fully Independent in Functional Lower Extremity Tasks). | 10 mins |