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

Unilateral Strength Training and Mirror Therapy for Enhancing Upper Limb Motor Function Post Stroke: A Pilot Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Mirror Therapy; Other: Cross-Education of Strengthening.

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co Sligo
    • Sligo, Co Sligo, Ireland, F91YW50
      • Institute of Technology, Sligo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Peak Torque Isometric elbow extension strength.	Assessed with the Biodex System 3 Pro Isokinetic Dynamometer with the Biodex Advantage Software version 3.45 (Biodex Medical Systems, Inc., Shirley, New York, USA). Highest Peak Torque out of 5 single isometric contractions was analysed. A higher peak torque measurement indicates a greater contraction strength.	10 minutes
Maximal Rate of Torque Development Isometric elbow extension strength.	Assessed with the Biodex System 3 Pro Isokinetic Dynamometer with the Biodex Advantage Software version 3.45 (Biodex Medical Systems, Inc., Shirley, New York, USA). Highest Rate of Torque Development out of 5 single isometric contraction was analysed. A higher rate of torque measurement indicates a greater contraction strength.	10 minutes
Maximal Rate of Torque Development Isometric elbow extension strength.	Assessed with the Biodex System 3 Pro Isokinetic Dynamometer with the Biodex Advantage Software version 3.45 (Biodex Medical Systems, Inc., Shirley, New York, USA). Average Torque Development out of 5 single isometric contractions was analysed. A higher average torque measurement indicates a greater contraction strength.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS).	Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).	10 minutes.
Chedoke Arm and Hand Activity Inventory - 8 Version	Assessment of the International Classification of Functioning, Disability and Health activity level. Eight upper limb tasks, defined according to literature and stroke patients' experience, are scored on a 7-point scale, 1 point standing for total assistance, 7 points standing for complete independence. Range 7 (Total assistance required for all upper limb tasks) - 56 (Complete Independence with all upper limb tasks).	10 mins
ABILHAND Questionnaire	Measurement of patient's self-reported ability to perform complex hand activities for 23 daily situations. Possible answers are easy, difficult or impossible. The online converter will give a percentage score between 0% (Complete self perceived inability to perform upper limb tasks and 100% (Complete self-perceived ability to perform all upper limb tasks).	10 mins
London Handicap Scale (LHS).	Measurement of self-perceived impact of stroke over 6 domains of a patient's life (mobility, physical independence, occupation, social integration, orientation, and economic self - sufficiency). Scoring range of 0 to 1, where a score of 1 indicated 'No Disadvantage and a score of 0 indicates 'most severe disadvantage'.	10 minutes

Collaborators and Investigators

• Sponsor: Institute of Technology, Sligo
• Investigators: Principal Investigator: Monika Ehrensberger, PhD, IT Sligo

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2014
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 15, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 15, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ITSligo Monika Ehrensberger

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD is shared with any other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No