Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

NCT03468504 | Completed

• 1 other identifier: ITSligo
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Modified Ashworth Scale

  10 minutes

• Fugl-Meyer Assessment-Lower extremity

  10 mins

Study Arms (2)

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.

Device: Mirror Therapy; Device: Treadmill

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.

Device: Placebo Mirror Therapy; Device: Treadmill

Interventions

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.

Also known as: Mirror Designed by IT Sligo.

Mirror Therapy & Treadmill Training

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.

Also known as: Mirror Designed by IT Sligo.

Placebo Mirror & Treadmill Training

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.

Also known as: Variable speed Treadmill.

Mirror Therapy & Treadmill Training; Placebo Mirror & Treadmill Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Younger than 18 years
• Any additional illness that may prevent treadmill walking
• A Mini Mental State Examination \< 24.

Sponsors & Collaborators

• Institute of Technology, Sligo: lead

Study Sites (1)

Institute of Technology, Sligo

Sligo, Co Sligo, F91YW50, Ireland

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy; Exercise Test

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Patrick Broderick, PhD

  PhD researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Model Details: Pilot Randomised Placebo Controlled Trial

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 16, 2018
• Study Start: April 1, 2014
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)