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

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ClinicalTrials.gov Identifier: NCT02949609
Recruitment Status : Terminated (investigator)
First Posted : October 31, 2016
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Leemann Beatrice, 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.


Condition or disease Intervention/treatment Phase
Stroke Other: Mirror Therapy Other: Control Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
Study Start Date : June 17, 2016
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : November 17, 2017

Arm Intervention/treatment
Experimental: Mirror Therapy (MT)
Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists.
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.

Active Comparator: Control Therapy (CT)
Standard therapy + 30 min/day of CT.
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.




Primary Outcome Measures :
  1. Change in Fugl Meyer Assessment - Upper Limb (FMA-UE) [ Time Frame: 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 :
  1. Change in Functional Independence Measure (FIM) [ Time Frame: 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.

  2. Change in Bell cancellation task [ Time Frame: 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.

  3. Change in Line bisection task [ Time Frame: 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.

  4. Change in Numeric pain scale [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949609


Locations
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Switzerland
Service de Neurorééducation - Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Béatrice Leemann, Doctor Hôpitaux Universitaires de Genève
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Responsible Party: Leemann Beatrice, Medical Doctor (MD), University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02949609    
Other Study ID Numbers: 2016-00091
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Leemann Beatrice, University Hospital, Geneva:
stroke
mirror therapy
neurorehabilitation
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations