Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468504
• Other study ID #: ITSligo
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: January 10, 2018

Study information

• Verified date: May 2018
• Source: Institute of Technology, Sligo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Ireland	Institute of Technology, Sligo	Sligo	Co Sligo

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Technology, Sligo

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ten Metre Walk Test	Walking velocity measure. Lower times indicate an increased walking velocity.	5 mins.
Primary	Six Minute Walk Test	Walking endurance measure. Larger distance indicates an improved walking endurance ability.	10 mins
Secondary	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
Secondary	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