Clinical trial NCT02949609: Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
Official title: Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: stroke
mirror therapy
neurorehabilitation
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Fugl Meyer Assessment - Upper Limb (FMA-UE)
timeFrame: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Secondary outcomes:
measure: Change in Functional Independence Measure (FIM)
timeFrame: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
measure: Change in Bell cancellation task
timeFrame: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
measure: Change in Line bisection task
timeFrame: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
measure: Change in Numeric pain scale
timeFrame: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Service de Neurorééducation - Hôpitaux Universitaires de Genève
Study officials:
affiliation: University Hospital, Geneva
name: Béatrice Leemann, Doctor
role: PRINCIPAL_INVESTIGATOR
References: