Upper Limb Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients

NCT ID: NCT03500705

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-22
• Study Completion Date: 2017-08-16

Brief Summary

This is a pilot randomised controlled trial investigating a combination of unilateral strength training (cross-education) and mirror therapy for the rehabilitation of upper 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 assessments being conducted at the institute and all therapy sessions taking place at the participant's home. 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 perform a strength training programme with their less-affected upper limb. The mirror and strength training group observed the reflection of the training limb in a mirror, the strength training only group exercised without a mirror entirely. 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 32 participants were recruited. After a warm-up participants performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb, 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 follow-up assessment. All assessments were carried out by a blinded Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for upper limb isometric strength, motor function, muscle tone, and self-perceived participation.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mirror Therapy + Cross-Education.

Patients performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb (Cross-Education of Strengthening) while observing the reflection of the exercising limb in the mirror (Mirror Therapy) which was placed in the patient's mid-sagittal plane. Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals.

Group Type: EXPERIMENTAL

Mirror Therapy

Intervention Type: DEVICE

Mirror Therapy involved the patient sitting on a chair at a table with a standard mirror placed on the table in the mid-sagittal plane between both arms, with the reflective side of the mirror facing the non-affected arm. The patient is instructed to observe the reflection of the non-affected arm during the sessions. The patient was not given any instruction on the use of the affected arm.

Cross-Education of Strengthening.

Intervention Type: OTHER

Cross-education of strengthening involves training one side of the body with the intention of producing strengthening gains on both sides of the body. In this case the strengthening was done on the non-affected arm of each stroke patient.

Cross-Education of Strengthening.

Patients trained without a mirror entirely. They performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb (Cross-Education of Strengthening). Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals.

Group Type: ACTIVE_COMPARATOR

Cross-Education of Strengthening.

Intervention Type: OTHER

Cross-education of strengthening involves training one side of the body with the intention of producing strengthening gains on both sides of the body. In this case the strengthening was done on the non-affected arm of each stroke patient.

Interventions

Mirror Therapy

Mirror Therapy involved the patient sitting on a chair at a table with a standard mirror placed on the table in the mid-sagittal plane between both arms, with the reflective side of the mirror facing the non-affected arm. The patient is instructed to observe the reflection of the non-affected arm during the sessions. The patient was not given any instruction on the use of the affected arm.

Intervention Type: DEVICE

Cross-Education of Strengthening.

Cross-education of strengthening involves training one side of the body with the intention of producing strengthening gains on both sides of the body. In this case the strengthening was done on the non-affected arm of each stroke patient.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Chronic stroke diagnosed by a physician at least 6 months prior to study begin Discharged from formal rehabilitation services (not receiving outpatient rehabilitation on more than a monthly basis, but may still be in receipt of occupational or language therapy).

Exclusion Criteria

Impaired cognition (Mini mental state examination (MMSE) < 21) Cardiovascular, neurological or musculoskeletal impairments of the upper extremity not related to stroke that would prevent strength training.

Visual impairments that would interfere with the ability to participate safely in isometric training and observe mirror images.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Technology, Sligo

OTHER

Sponsor Role: lead

Responsible Party

Dr. John Bartlett

Head of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monika Ehrensberger, PhD

Role: PRINCIPAL_INVESTIGATOR

IT Sligo

Locations

Institute of Technology, Sligo

Sligo, Co Sligo, Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ITSligo Monika Ehrensberger

Identifier Type: -

Identifier Source: org_study_id