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

NCT03500705 | Completed

• 1 other identifier: ITSligo Monika Ehrensberger
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Modified Ashworth Scale (MAS).

  10 minutes.

• Chedoke Arm and Hand Activity Inventory - 8 Version

  10 mins

• ABILHAND Questionnaire

  10 mins

• London Handicap Scale (LHS).

  10 minutes

Study Arms (2)

Mirror Therapy + Cross-Education.

EXPERIMENTAL

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; Other: Cross-Education of Strengthening.

Cross-Education of Strengthening.

ACTIVE COMPARATOR

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.

Interventions

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.

Mirror Therapy + Cross-Education.

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.

Cross-Education of Strengthening.; Mirror Therapy + Cross-Education.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Technology, Sligo: lead

Study Sites (1)

Institute of Technology, Sligo

Sligo, Co Sligo, F91YW50, Ireland

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Monika Ehrensberger, PhD

  IT Sligo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor only was masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Model Details: Pilot Randomised Controlled Trial

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 18, 2018
• Study Start: October 22, 2014
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)