Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Mirror Therapy; Device: Treadmill; Device: Placebo Mirror Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co Sligo
    • Sligo, Co Sligo, Ireland, F91YW50
      • Institute of Technology, Sligo

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: Mirror Designed by IT Sligo.; 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.; Other Names: Variable speed Treadmill.
Placebo Comparator: 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.	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.; Other Names: Variable speed Treadmill.; 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.; Other Names: Mirror Designed by IT Sligo.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Technology, Sligo
• Investigators: Principal Investigator: Patrick Broderick, PhD, PhD researcher

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ITSligo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD is shared with any other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No