Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke (MT)

After stroke, patients frequently suffer from arm or hand weakness. There are numerous rehabilitation methods to stimulate recovery, amongst which mirror therapy (MT). It is particularly interesting in cases for which impairment is severe, as many other forms of therapy are often impossible.

During MT, a mirror is placed in the midsagittal plane, so as to hide the impaired limb. Thereafter, the subject is asked to move his unimpaired limb while looking at its reflection in the mirror, thereby creating the illusion that the contralateral, impaired limb is moving.

The objective of this study is to better determine the efficacy of MT. The investigators will therefore compare recovery of arm function in two groups of patient, that perform a regimen of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional therapy. One group performs MT and the other one performs a therapy in which the same movements are performed, but without the use of a mirror, with unrestricted view of both limbs. Allocation to each group will be randomized. Arm function will be evaluated by use of a scale before, during and after the 4 week period. The assessor for the primary outcome measure will not know in which group the patient is. There will be a total of 30 patients included over a one year study period.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Other: Mirror Therapy; Other: Control Therapy

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Service de Neurorééducation - Hôpitaux Universitaires de Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ischemic or hemorrhagic stroke, diagnosed clinically and by imagery, more than one month after onset;
• Severe upper limb paresis with Upper-Extremity Fugl-Meyer Score < 19/60 .

Exclusion Criteria:

• Significant limitation in upper limb function predating the recent stroke, caused by former symptomatic stroke and/or an orthopedic/rheumatologic disease;
• Neuropsychologic or psychiatric impairment with significant interference with participation in therapy;
• Severe visual impairment.

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 (MT); Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists.	Other: Mirror Therapy; Mirror therapy will consist in placing a large mirror in the sagittal plane of the subject so as to reflect his healthy arm while hiding the paretic one, and then asking him to perform movements of his healthy arm while looking at its reflection in the mirror.
Active Comparator: Control Therapy (CT); Standard therapy + 30 min/day of CT.	Other: Control Therapy; Performance of the same movements as the experimental group without the mirror or instructions as to where to look, 5 days/week, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl Meyer Assessment - Upper Limb (FMA-UE)	Change in Fugl Meyer Assessment - Upper Limb (FMA-UE) at different time points: before, during, after intervention and after a 6 week follow-up.	Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Independence Measure (FIM)	Change in Functional Independence Measure (FIM) at different time points: before, during, after intervention and after a 6 week follow-up.	Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Change in Bell cancellation task	Change in Bell cancellation task at different time points: before, during, after intervention and after a 6 week follow-up.	Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Change in Line bisection task	Change in Line bisection task at different time points: before, during, after intervention and after a 6 week follow-up.	Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Change in Numeric pain scale	Change in Numeric pain scale at different time points: before, during, after intervention and after a 6 week follow-up.	Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Béatrice Leemann, Doctor, Hôpitaux Universitaires de Genève

Study record dates

Study Major Dates

• Study Start: June 17, 2016
• Primary Completion (Actual): November 17, 2017
• Study Completion (Actual): November 17, 2017

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: stroke; neurorehabilitation; mirror therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: 2016-00091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No