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NCT Number: NCT03500705

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

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.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Mirror Therapy

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.

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.

Primary outcomes

  1. Maximal Peak Torque Isometric elbow extension strength.

    Time frame: 10 minutes

    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.

  2. Maximal Rate of Torque Development Isometric elbow extension strength.

    Time frame: 10 minutes

    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.

  3. Maximal Rate of Torque Development Isometric elbow extension strength.

    Time frame: 10 minutes

    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.

Secondary outcomes

  1. Modified Ashworth Scale (MAS).

    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. Chedoke Arm and Hand Activity Inventory - 8 Version

    Time frame: 10 mins

    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).

  3. ABILHAND Questionnaire

    Time frame: 10 mins

    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).

  4. London Handicap Scale (LHS).

    Time frame: 10 minutes

    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'.

Sponsors and collaborators

Lead sponsor

Institute of Technology, Sligo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2018
Registry last updated
Apr 18, 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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