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

Stroke Clinical Trial

— MT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02949609
• Other study ID #: 2016-00091
• Status: Terminated
• Phase: N/A
• Start date: June 17, 2016
• Est. completion date: November 17, 2017

Study information

• Verified date: September 2019
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Paresis
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Service de Neurorééducation - Hôpitaux Universitaires de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.