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

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Other: Mirror Therapy; Other: Control Therapy

• Registration Number: NCT02949609
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-17
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Primary Completion: 2017-11-17
• Study Completion: 2017-11-17
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirror Therapy (MT)	Mirror Therapy	Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists.
Control Therapy (CT)	Control Therapy	Standard therapy + 30 min/day of CT.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 Bell cancellation task at different time points: before, during, after intervention and after a 6 week follow-up.
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.	Change in Numeric pain scale at different time points: before, during, after intervention and after a 6 week follow-up.
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 Functional Independence Measure (FIM) at different time points: before, during, after intervention and after a 6 week follow-up.
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 Line bisection task at different time points: before, during, after intervention and after a 6 week follow-up.

Trial Locations

Locations (1)

Service de Neurorééducation - Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland