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NCT Number: NCT03468504

Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Technology, Sligo

Sligo, Co Sligo, F91YW50, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Mirror Designed by IT Sligo.

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.

Other names: Mirror Designed by IT Sligo.

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.

Other names: Variable speed Treadmill.

Primary outcomes

  1. Ten Metre Walk Test

    Time frame: 5 mins.

    Walking velocity measure. Lower times indicate an increased walking velocity.

  2. Six Minute Walk Test

    Time frame: 10 mins

    Walking endurance measure. Larger distance indicates an improved walking endurance ability.

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: 10 minutes

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

  2. Fugl-Meyer Assessment-Lower extremity

    Time frame: 10 mins

    Motor function outcome. Range 0 (Unable to do any functional Task) to 34 (Fully Independent in Functional Lower Extremity Tasks).

Sponsors and collaborators

Lead sponsor

Institute of Technology, Sligo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2018
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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