StrokeMTNCT02949609
Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
A study testing Mirror Therapy in people with Stroke, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jun 2016to 17 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service de Neurorééducation - Hôpitaux Universitaires de Genève
Geneva, 1205
About this study
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.
- Conditions
- Stroke
- Being tested
- Mirror Therapy, Control Therapy
- Keywords
- stroke, mirror therapy, neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyOther
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy (MT) | Experimental | Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists. Receives: Other: Mirror Therapy |
| Control Therapy (CT) | Active comparator | Standard therapy + 30 min/day of CT. Receives: Other: Control Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Secondary outcomes (4)
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.
Measured: 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
Change in Bell cancellation task at different time points: before, during, after intervention and after a 6 week follow-up.
Measured: 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
Change in Line bisection task at different time points: before, during, after intervention and after a 6 week follow-up.
Measured: 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
Change in Numeric pain scale at different time points: before, during, after intervention and after a 6 week follow-up.
Measured: Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start17 Jun 2016
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Why it stopped: investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leemann Beatrice, University Hospital, Geneva
- Investigators
- Béatrice Leemann, Doctor, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949609
- Sponsor's protocol ID
- 2016-00091
- Other IDs
- 2016
- Acronym
- MT
- Status last verified
- Sep 2019
- First submitted
- 25 Oct 2016
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke
- ClinicalTrials.gov ID
- NCT02949609
- Acronym / sponsor ID
- MT / 2016-00091
- Conditions
- Stroke
- Keywords
- stroke, mirror therapy, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: investigator
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 17 Jun 2016
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy (MT) | Experimental | Other: Mirror TherapyStandard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists. |
| Control Therapy (CT) | Active comparator | Other: Control TherapyStandard therapy + 30 min/day of CT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror TherapyMirror 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. | Other | Mirror Therapy (MT) |
| Control TherapyPerformance of the same movements as the experimental group without the mirror or instructions as to where to look, 5 days/week, for 4 weeks. | Other | Control Therapy (CT) |
Primary outcome
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.
4 secondary outcomes
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 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 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 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.
Results and safety
The study was stopped early (reason given: investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice Leemann, Doctor principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy in people with Stroke, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.