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

NCT02949609 | Terminated DMC

• 1 other identifier: 2016-00091
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; mirror therapy; neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Functional Independence Measure (FIM)

  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

  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

  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

  Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.

Study Arms (2)

Mirror Therapy (MT)

EXPERIMENTAL

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

Other: Mirror Therapy

Control Therapy (CT)

ACTIVE COMPARATOR

Standard therapy + 30 min/day of CT.

Other: Control Therapy

Interventions

Mirror Therapy 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.

Mirror Therapy (MT)

Control Therapy 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.

Control Therapy (CT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Service de Neurorééducation - Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

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

• Béatrice Leemann, Doctor

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (MD)

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: June 17, 2016
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)