Brief description of trial (Data source: BASEC)
Le but de cette étude est d'évaluer l'efficacité du MindMotionPRO, un dispositif médical de rééducation motrice basé sur la réalité virtuelle, chez des patients après un Accident Vasculaire Cérébral. L’efficacité sera évaluée par la durée de rééducation, des échelles de performance et le rapport coût-efficacité.
Health conditions investigated(Data source: BASEC)
Rééducation motrices des membres supérieurs après un Accident Vasculaire Cérébral (AVC)
Health conditions
(Data source: WHO)
Stroke;Motor Disorders
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Le groupe expérimental suivra des exercices fournis par MindMotionPRO: activités du quotidien dans un environnement virtuel). Le groupe contrôle suivra le programme GRASP (Graded Repetitive Arm Supplementary Program): des exercices auto-dirigés incluant des activités du quotidien et des mouvements fonctionnels. Ces deux types d’exercices seront en complément au thérapie standard de rééducation motrice, pendant 4 semaines, avec 5 sessions par semaine.
Interventions
(Data source: WHO)
Device: MindMotionPRO;Other: Self-Directed Prescribed Exercises
Criteria for participation in trial
(Data source: BASEC)
- Homme ou femme âgés de plus de 18 ans
- De 1 à 6 semaines aprés un premier AVC avec une faiblesse du membre supérieur controlatéral (FMA entre 20 et 40)
- Capable de donner un consentement éclairé
Exclusion criteria
(Data source: BASEC)
- Quelconque trouble médical compromettant la sécurité ou la capacité à participer à l’étude (tel qu’une vision ou ouïe insuffisante, incapacité à participer aux sessions de thérapie, incapacité à communiquer, trouble des membres supérieurs non lié à l’AVC, pression artérielle non contrôlée, diabète non contrôlé, comorbidité)
- Douleur récurrente des membres supérieurs d’intensité modérée à élevée, limitant la dose de rééducation
- Historique de plus d’une crise d’épilepsie depuis l’AVC ou crise d’épilepsie non contrôlée
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Male/female > 18 years old
- First ever unilateral supratentorial ischemic stroke with contralateral upper
extremity weakness
- 1 to 6 weeks post-stroke
- Able to give informed consent
- Not participating any other intervention studies
- Experiencing motor difficulties in using the paretic arm, with a FMA-UE score in the
range of 20 to 40 out of 66
- Stroke severity with NIHSS score between 5 (mild) and 14 (moderate) out of 42
- The participant is expected to remain available (geographically stable) for 4 months
after enrolment.
Exclusion Criteria:
- Any medical condition compromising the safety or the ability to take part to the study
(such as insufficient vision or hearing, inability to participate to therapy session,
inability to communicate, upper limb condition not linked to stroke, uncontrolled
blood pressure, uncontrolled diabetes, co-morbidity)
- Recurrent and moderate to high upper limb pain limiting delivery of rehabilitation
dose
- History of more than one epileptic seizures since stroke onset or uncontrolled
epileptic seizure
- Mild to severe cognitive impairment (Mini mental state exam (MMSE) score < 24/30)
- Depression (Hospital Anxiety and Depression Scale > 8/21)
- Moderate to severe hemispatial neglect compromising the ability to take part to the
study, as determined by the Bells tests (> 6 errors)
- Brain stem stroke
-
Further information on trial
Date trial registered
Feb 12, 2016
Incorporation of the first participant
Aug 1, 2016
Recruitment status
Terminated
Academic title
(Data source: WHO)
Randomized Parallel-group Study Evaluating the Effectiveness and Cost-effectiveness of the Co-administration of MindMotionPRO Plus Standard Practice Versus Standard Practice in Early Post-stroke Upper-limb Rehabilitation
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
Secundary end point
(Data source: WHO)
Motivation measured by the Intrinsic Motivation Index (IMI);Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL);Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS);Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS);Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY);Change from Baseline in self-care ability measured by the Barthel index (BI);Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score;Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales;Number of exercises performed
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
Undecided
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Lausanne
Countries
(Data source: WHO)
Germany, Italy, Switzerland, United Kingdom
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Cyntia Duc
+41 21 552 08 01
cyntia.duc@mindmaze.ch
Contact for general information
(Data source: WHO)
Valeria Caso, MD
Azienda Ospedale Santa Maria della Misericordia, Italy
Contact for scientific information
(Data source: WHO)
Valeria Caso, MD
Azienda Ospedale Santa Maria della Misericordia, Italy
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Date of authorisation by the ethics committee
18.05.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00396
Secondary ID (Data source: WHO)
MindMaze-2016-RCT01
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