Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

NCT ID: NCT03468504

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2018-01-10

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot Randomised Placebo Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Mirror Therapy & Treadmill Training

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.

Group Type EXPERIMENTAL

Mirror Therapy

Intervention Type 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.

Treadmill

Intervention Type DEVICE

Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.

Placebo Mirror & Treadmill Training

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.

Group Type PLACEBO_COMPARATOR

Placebo Mirror Therapy

Intervention Type 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.

Treadmill

Intervention Type DEVICE

Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.

Interventions

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Mirror Therapy

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.

Intervention Type DEVICE

Placebo Mirror Therapy

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.

Intervention Type DEVICE

Treadmill

Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.

Intervention Type DEVICE

Other Intervention Names

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Mirror Designed by IT Sligo. Mirror Designed by IT Sligo. Variable speed Treadmill.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Technology, Sligo

OTHER

Sponsor Role lead

Responsible Party

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Dr. John Bartlett

Head of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Broderick, PhD

Role: PRINCIPAL_INVESTIGATOR

PhD researcher

Locations

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Institute of Technology, Sligo

Sligo, Co Sligo, Ireland

Site Status

Countries

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Ireland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ITSligo

Identifier Type: -

Identifier Source: org_study_id

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