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Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Mirror Therapy
Placebo Mirror Therapy
Treadmill
Sponsored by
Institute of Technology, Sligo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Technology, Sligo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirror Therapy & Treadmill Training

Placebo Mirror & Treadmill Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ten Metre Walk Test
Walking velocity measure. Lower times indicate an increased walking velocity.
Six Minute Walk Test
Walking endurance measure. Larger distance indicates an improved walking endurance ability.

Secondary Outcome Measures

Modified Ashworth Scale
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).
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).

Full Information

First Posted
February 19, 2018
Last Updated
May 8, 2018
Sponsor
Institute of Technology, Sligo
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1. Study Identification

Unique Protocol Identification Number
NCT03468504
Brief Title
Mirror Therapy and Treadmill Training for Patients With Chronic Stroke
Official Title
Mirror Therapy and Treadmill Training for Patients With Chronic Stroke: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Technology, Sligo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot Randomised Placebo Controlled Trial
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror Therapy & Treadmill Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Mirror & Treadmill Training
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mirror Therapy
Other Intervention Name(s)
Mirror Designed by IT Sligo.
Intervention Description
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
Intervention Name(s)
Placebo Mirror Therapy
Other Intervention Name(s)
Mirror Designed by IT Sligo.
Intervention Description
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
Intervention Name(s)
Treadmill
Other Intervention Name(s)
Variable speed Treadmill.
Intervention Description
Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.
Primary Outcome Measure Information:
Title
Ten Metre Walk Test
Description
Walking velocity measure. Lower times indicate an increased walking velocity.
Time Frame
5 mins.
Title
Six Minute Walk Test
Description
Walking endurance measure. Larger distance indicates an improved walking endurance ability.
Time Frame
10 mins
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).
Time Frame
10 minutes
Title
Fugl-Meyer Assessment-Lower extremity
Description
Motor function outcome. Range 0 (Unable to do any functional Task) to 34 (Fully Independent in Functional Lower Extremity Tasks).
Time Frame
10 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Broderick, PhD
Organizational Affiliation
PhD researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Technology, Sligo
City
Sligo
State/Province
Co Sligo
ZIP/Postal Code
F91YW50
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD is shared with any other researchers.

Learn more about this trial

Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

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