Mirror Aided Cross Education in Post Stroke Upper Limb Rehabilitation.

NCT05293951 | Completed

• 1 other identifier: ITSligo NRG
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomised controlled trial investigating a combination of mirror therapy and cross-education training compared to mirror therapy alone for the rehabilitation of upper limb impairment following a stroke. A case study series will be completed in advance of the full randomised controlled trial. The outcome measure assessments will take place at the institution. All intervention therapy sessions will be completed by the participant in their own home with the first introductory session being completed with the lead researcher. The study will be conducted in conjunction with Sligo University Hospital once it has attained ethical approval through the relevant University Hospital Ethics Committee.

Conditions

Stroke

Keywords

Mirror Therapy; Cross-education Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Isokinetic Upper Limb Strength

  (Biodex System 4 Pro with advantage software) IPRS Limited, Suffolk House, Bramford Road, Little Blakenham, Suffolk, IP8 4JU. A higher score indicates more strength.

  4 weeks.

Secondary Outcomes (4)

• Upper limb range of movement.

  4 weeks.

• Modified Ashworth Scale (MAS) for spasticity.

  4 weeks.

• Stroke Impact Scale measures Handicap.

  4 weeks.

• Fugl Meyer Upper Extremity Test

  4 weeks.

Study Arms (2)

Mirror Therapy + Cross Education

EXPERIMENTAL

Cross Education: Experimental participants will perform resisted task-specific upper limb exercises. During the exercises, participants will pull a resistance cord with their non-affected arm, Mirror Therapy: Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.

Device: Mirror Strengthening Device

Mirror Therapy Alone

ACTIVE COMPARATOR

Mirror Therapy: Control participants will perform non-resisted task-specific upper limb exercises. Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.

Device: Mirror Therapy

Interventions

Mirror Strengthening Device DEVICE

Participants will perform resisted task-specific upper limb exercises. During the exercises, participants will pull a resistance cord with their non-affected arm, Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm. The initial resistance will be chosen based on the participants initial outcome measure results. Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.

Mirror Therapy + Cross Education

Mirror Therapy DEVICE

Participants will perform non-resisted task-specific upper limb exercises. During the exercises, participants will be watching their non affected arm reflected in a mirror covering their affected arm. Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.

Mirror Therapy Alone

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of ischemic or hemorrhagic stroke as determined by a stroke neurologist. Stroke will be defined as an acute event of cerebrovascular origin causing focal or global neurologic dysfunction lasting more than 24 hours diagnosed by a neurologist/gerontologist, and confirmed by computed tomography or magnetic resonance imaging.
• ≥3 months post stroke; with no restrictions on how long post stroke.
• Discharged from formal physiotherapy rehabilitation services.
• Unilateral upper limb weakness with a Medical Research Council (MRC) Scale for Strength score greater than 2 (i.e., movement with influence of gravity removed) in the limb to be assessed and treated.
• Functional active range of movement and power in non-hemiparetic side.
• Ambulatory with or without use of a walking device. Must be able to transfer into the Biodex machine.
• Older than 18 yrs.
• Not involved in any other type of structured strength training for the duration of the study.

You may not qualify if:

• Diagnosis of additional neurological condition (including more than one stroke) or cardiovascular disease.
• Presence of musculoskeletal conditions affecting the bones and/or soft tissues of the upper extremity.
• Impaired cognition that would affect ability to informed consent (MMSE \<21).
• Presence of aphasia or visual impairments.
• Medications affecting tone less than 3/12 prior.

Sponsors & Collaborators

• Institute of Technology, Sligo: lead
• Sligo General Hospital: collaborator

Study Sites (1)

ATU Sligo

Sligo, Co Sligo, F94KR28, 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

• Claire Smyth, BSc

  Institute of Technology, Sligo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Experimental participants will perform resisted task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will pull a resistance cord with their non-affected arm, while looking at its reflection in a mirror covering their affected arm. Control participants will perform non-resisted task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will be watching their non-affected arm reflected in a mirror covering their affected arm. The outcome assessor was blinded to treatment allocation. They evaluated participants in a separate lab and were asked not to discuss the treatment given to patients. Even if the the patient mentioned the trials they would discuss the fact that they were using Mirrors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Supervisor & Head of Neuroplasticity Research Group (NRG)

Model Details: Pilot Randomised Controlled Trial

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 24, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)