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

NCT ID: NCT02949609

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-17
• Study Completion Date: 2017-11-17

Brief Summary

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mirror Therapy (MT)

Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists.

Group Type: EXPERIMENTAL

Mirror Therapy

Intervention Type: OTHER

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.

Control Therapy (CT)

Standard therapy + 30 min/day of CT.

Group Type: ACTIVE_COMPARATOR

Control Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Leemann Beatrice

Medical Doctor (MD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Béatrice Leemann, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Service de Neurorééducation - Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2016-00091

Identifier Type: -

Identifier Source: org_study_id