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

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mirror Therapy
Control Therapy
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, mirror therapy, neurorehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service de Neurorééducation - Hôpitaux Universitaires de Genève

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mirror Therapy (MT)

Control Therapy (CT)

Arm Description

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

Standard therapy + 30 min/day of CT.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 25, 2016
Last Updated
September 26, 2019
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT02949609
Brief Title
Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
Acronym
MT
Official Title
Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
investigator
Study Start Date
June 17, 2016 (undefined)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
November 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, mirror therapy, neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror Therapy (MT)
Arm Type
Experimental
Arm Description
Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists.
Arm Title
Control Therapy (CT)
Arm Type
Active Comparator
Arm Description
Standard therapy + 30 min/day of CT.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Therapy
Intervention Description
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 Measure Information:
Title
Change in Fugl Meyer Assessment - Upper Limb (FMA-UE)
Description
Change in Fugl Meyer Assessment - Upper Limb (FMA-UE) at different time points: before, during, after intervention and after a 6 week follow-up.
Time Frame
Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Secondary Outcome Measure Information:
Title
Change in Functional Independence Measure (FIM)
Description
Change in Functional Independence Measure (FIM) at different time points: before, during, after intervention and after a 6 week follow-up.
Time Frame
Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Title
Change in Bell cancellation task
Description
Change in Bell cancellation task at different time points: before, during, after intervention and after a 6 week follow-up.
Time Frame
Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Title
Change in Line bisection task
Description
Change in Line bisection task at different time points: before, during, after intervention and after a 6 week follow-up.
Time Frame
Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Title
Change in Numeric pain scale
Description
Change in Numeric pain scale at different time points: before, during, after intervention and after a 6 week follow-up.
Time Frame
Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béatrice Leemann, Doctor
Organizational Affiliation
Hôpitaux universitaires de Genève
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurorééducation - Hôpitaux Universitaires de Genève
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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