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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirror Therapy & Treadmill Training | Experimental | 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. |
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| Placebo Mirror & Treadmill Training | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirror Therapy | Device | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Broderick, PhD | PhD researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Technology, Sligo | Sligo | Co Sligo | F91YW50 | Ireland |
No IPD is shared with any other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2014 | Mar 9, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2014 | Mar 9, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2014 | Mar 9, 2018 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000088762 | Mirror Movement Therapy |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006334 | Heart Function Tests |
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Pilot Randomised Placebo Controlled Trial
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Experimental Group saw mirror image of non-affected limb in mirror while walking on treadmill.
Placebo Group saw no refection of the non-affected limb due to positioning of mirror while walking on treadmill.
Outcome assessor was blinded to treatment allocation. They evaluated participants in separate lab and was asked not to discuss the treatment given to patients. Even if the patient mentioned the trials they would discuss the fact that they were using Mirrors and Treadmill.
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| Placebo Mirror Therapy | Device | 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. |
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| Treadmill | Device | Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks. |
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| 10 mins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003935 |
| Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |