Motor Recovery of the Severely Impaired Paretic Upper Limb After Mirror Therapy in Sub-acute Stroke

October 21, 2016 updated by: CHAN Wing Chiu, The Hong Kong Polytechnic University
Our study aims at investigating the effect of intensive mirror therapy on the motor recovery of severely impaired paretic arm at subacute stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It was reported that upper limb hemiparesis happened in 80% of stroke patients and only 20% regained full arm function 6 months post stroke. The paretic upper arm accounted for 50% of the variance in functional limitation after stroke. Early and intensive upper limb intervention can promote motor recovery of paretic arm and is associated with better upper limb functional outcomes on 6 month post stroke. Mirror therapy (MT) is one of the potential approach in enhancing motor recovery of paretic arm after stroke. However, the effect of intensive MT on the motor recovery of severely impaired paretic arm after stroke has not been investigated. Knowledge on the effect of intensive MT on motor recovery can enhance formulation of effective and efficiency treatment protocol in stroke rehabilitation. Therefore, our study aims at investigating the effect of intensive MT on the motor recovery of severely impaired paretic arm of patients at subacute phase of stroke.

Stroke patients admitted to Haven of Hope Hospital will be screened according to inclusion and exclusion criteria. Eligible subjects will consent and be randomized into two groups: MT group- subjects will have daily two 30-min sessions of standardized bilateral upper limbs exercise with presence of mirror, 5 days per week for 4 consecutive weeks. During MT, a mirror is placed in the patient's mid-sagittal plane, with the reflecting surface facing the non-paretic upper limb so that the reflected image of this non-paretic limb would be perceived as the paretic upper limb. Subjects are instructed to watch at the movements of the reflected image of the non-paretic limbs and at the same time, the paretic upper limb should imitate the observed movements and be synchronized with those of the good side. Standardized bilateral upper limbs exercise (4 sets of 30 repetitions of shoulder, elbow, wrist and fingers movements) will be carried out within 30 min per session. Control group subjects will receive same daily two sessions of standardized bilateral upper limbs exercise without mirror, 5 days per week for 4 consecutive weeks. Motor functions of paretic arm of subjects measured by Fugl-Meyer Assessment (motor domain) and Wolf Motor Function Test will be assessed by independent assessor who is blinded to the group allocation of subjects before and after the 4-week intervention. Baseline comparison between the two groups was tested with independent t-test and the difference among and between groups after intervention will be tested by repeated measures ANOVA with level of significant at 0.05.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Kowloon
      • Tseung Kwan O, Kowloon, Hong Kong
        • Haven of Hope Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 35 years or older
  • first stroke within the first month after stroke onset;
  • has upper limb paresis contralateral to the side of cerebral hemisphere with stroke;
  • Presence of active movements (at least flicker of movement in gravity free position, but not able to accomplish full range of motion against gravity) at any one joint of shoulder, elbow and hand of hemiplegic arm, and Motricity Index less than 47.
  • Able to follow instructions

Exclusion Criteria:

  • has visual impairment not correctable by corrective lens;
  • has cognitive impairment (Mini-Mental State Examination score < 22/30)
  • has comprehension or expression aphasia;
  • Presence of visuospatial neglect
  • has premorbid neurological or musculoskeletal conditions that affect movements in the upper limbs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirror therapy group
MT group subjects will attend training sessions of bilateral upper limb exercise daily in the presence of the mirror.
Other: mirror therapy

During MT, subjects will sit in front of a table on which a mirror will be placed vertically in the space ipsilateral to the paretic upper limb with its reflective surface facing the unaffected upper limb. The subjects are required to look at the mirror to observe the reflective image of the unaffected arm from shoulder to the hand, while it is performing certain designated movements. At the same time, the affected arm will be required to follow the unaffected arm to practice the same movements.

The upper limbs movements during the 30-min MT session are open and close of grasp; wrist flexion and extension; forearm supination and pronation; elbow flexion and extension; shoulder flexion and extension. A total of 120 repetitions for each action will be practiced.
Active Comparator: Control therapy group
Control group subjects will undergo the same training sessions of bilateral upper limb exercise daily without mirror.
Other: control therapy
Control group subjects undergo the same bilateral upper limbs exercise protocol without mirror

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Assessment arm score
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Wolf Motor Function Test
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Wing Chiu Chan, MSc, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20140613004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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