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出境医 / 临床实验 / Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke. (DEXTRAIN)
Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke. (DEXTRAIN)
Study Description
Brief Summary:
Stroke is the second leading cause of death and disability in France: more than half of stroke survivors have a disabling motor deficit, affecting mainly the upper limb. A lack of hand control makes everyday tasks more difficult and reduces the quality of life. The investigators lack approaches to specifically rehabilitate the hand after stroke.
Recently, a new tool has been developed to measure manual dexterity (the Finger Force Manipulandum or FFM). This tool, which records the forces applied by the fingers on pistons, allows to measure more finely the key components of manual dexterity during visuomotor tasks. The tool measures the ability to control and release the force applied by the fingers, to perform sequences, to track and maintain a frequency of tapping (temporality of movement) with the fingers, and to use the fingers independently one another.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Vascular Accident | Other: DEXTRAIN Other: CONVENTIONNELLE Other: CONTROLE | Not Applicable |
Detailed Description:
The DexTrain proof-of-concept study aims to evaluate the benefit of a training using a tool, an improved version of the FFM, named DexTrain, for the rehabilitation and specific training of the fingers in subjects suffering from stroke. In this study the investigators will compare the effect of conventional therapy with that of the DexTrain method, particularly on the function of the hand and its spontaneous use at home (ecological condition). To better understand the mechanisms involved, the investigators will also study brain plasticity using Transcranial Magnetic Stimulation (SMT) and Functional Magnetic Resonance Imaging (fMRI).
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 66 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of the Benefit of the Training of the Manual Dexterity Post-stroke: Effect on the Function and Spontaneous Use of the Hand and the Cerebral Plasticity |
| Actual Study Start Date : | February 2, 2018 |
| Estimated Primary Completion Date : | August 31, 2020 |
| Estimated Study Completion Date : | August 31, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: DEXTRAIN
The DexTrain group sessions will consist of 20 minutes of conventional training followed by 40 minutes of exercises using the DexTrain targeting dexterity components.
|
Other: DEXTRAIN
12 sessions of 1 hour of rehabilitation (3 sessions / 4 weeks) for the DexTrain group will consist of 20 minutes of conventional training followed by 40 minutes of exercises using the DexTrain targeting the dexterity components.
|
|
Active Comparator: CONVENTIONNELLE
Conventional training involving stretching of the spastic muscles as well as a set of exercises conventionally used in the protocols of post-stroke rehabilitation (repeated movements, manipulation of objects).
|
Other: CONVENTIONNELLE
12 sessions of 1 hour of rehabilitation (3 sessions / 4 weeks) Conventional will be constituted of conventional training consisting of stretching of the spastic muscles as well as exercises used classically in the protocols of rehabilitation post-stroke
|
|
CONTROLE
To compare the results of SMT and functional MRI.
|
Other: CONTROLE
Only one assessment will be provided for the control group which will include, Box & Blocks Test (BBT), FFM Dexterity Assessment, Moberg Pick-Up Test (MPUT), Maximal Finger Tapping Rate, Proprioception, SMT, fMRI, Spontaneous hand activity (accelerometry / portable electromyography)
|
Outcome Measures
Primary Outcome Measures :
- Change of Box and Block test score [ Time Frame: one month ]Change of the Box and Block test score, a measure of the number of blocks the subject can move in 1min, between the beginning (T0) and immediately after the end of treatment (T1). Range of score 0-120. A positive change represents improved performance on Box and Blocks test.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Patient :
- At least 18 years old
- 1st symptomatic stroke, due to acute vascular injury (ischemic or haemorrhagic) affecting a single arterial territory dating from 3 months or more (multiple territory: corresponds to a bi-hemispheric or vertebrobasilar stroke and carotid for ischemic and bi-hemispherical stroke for hemorrhagic stroke)
- With a slight-to-moderate deficit of manual dexterity, indicated by a difficulty in picking up blocks in the Box and Block test (<52 blocks / minute, minimum 1 block) as well as an expansion capacity of 10 ° wrist and metacarpophalangeal joints of the index and middle finger.
- Affiliated to a social security scheme, Universal Health Cover or any other equivalent plan.
Volunteers :
- At least 18 years old
- Healthy subject of any disease affecting the hand,
Exclusion Criteria:
-
Significant disability or pre-existing deficiency that may interfere with study-specific assessments:
• History of symptomatic stroke
- Disorders of the understanding not allowing a good comprehension of the tests of motor skills (severe aphasia, dementia, etc.) evaluated by the MMSE (<25)
- Botulinum toxin treatment of spastic muscles of the upper limb less than three months before inclusion and / or during rehabilitation (4 weeks).
- Another severe disease making follow-up difficult.
Contacts and Locations
Contacts
| Contact: Jean Louis MAS, PUPH | 0145658284 ext 33 | jl.mas@ch-sainte-anne.fr | |
| Contact: Sylvie DOROCANT | s.dorocant@ch-sainte-anne.fr |
Locations
| France | |
| Centre hospitalier Sainte-Anne | Recruiting |
| Paris, France, 75014 | |
| Contact: Pavel LINDBERG, MD pavel.lindberg@inserm.fr | |
| Contact: Sylvie DOROCANT s.dorocant@ch-sainte-anne.fr | |
Sponsors and Collaborators
Centre Hospitalier St Anne
Investigators
| Principal Investigator: | Jean Louis MAS, PUPH | Centre Hospitalier Sainte Anne |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||||||
| First Posted Date ICMJE | May 1, 2019 | ||||||||
| Last Update Posted Date | May 3, 2019 | ||||||||
| Actual Study Start Date ICMJE | February 2, 2018 | ||||||||
| Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change of Box and Block test score [ Time Frame: one month ] Change of the Box and Block test score, a measure of the number of blocks the subject can move in 1min, between the beginning (T0) and immediately after the end of treatment (T1). Range of score 0-120. A positive change represents improved performance on Box and Blocks test.
|
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| Original Primary Outcome Measures ICMJE |
Improvement of Box and Block test score [ Time Frame: one month ] Improvement of the Box and Block test score (number of blocks moved / 1min) between the beginning (T0) and immediately after the end of treatment (T1).
|
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke. | ||||||||
| Official Title ICMJE | Evaluation of the Benefit of the Training of the Manual Dexterity Post-stroke: Effect on the Function and Spontaneous Use of the Hand and the Cerebral Plasticity | ||||||||
| Brief Summary |
Stroke is the second leading cause of death and disability in France: more than half of stroke survivors have a disabling motor deficit, affecting mainly the upper limb. A lack of hand control makes everyday tasks more difficult and reduces the quality of life. The investigators lack approaches to specifically rehabilitate the hand after stroke. Recently, a new tool has been developed to measure manual dexterity (the Finger Force Manipulandum or FFM). This tool, which records the forces applied by the fingers on pistons, allows to measure more finely the key components of manual dexterity during visuomotor tasks. The tool measures the ability to control and release the force applied by the fingers, to perform sequences, to track and maintain a frequency of tapping (temporality of movement) with the fingers, and to use the fingers independently one another. |
||||||||
| Detailed Description | The DexTrain proof-of-concept study aims to evaluate the benefit of a training using a tool, an improved version of the FFM, named DexTrain, for the rehabilitation and specific training of the fingers in subjects suffering from stroke. In this study the investigators will compare the effect of conventional therapy with that of the DexTrain method, particularly on the function of the hand and its spontaneous use at home (ecological condition). To better understand the mechanisms involved, the investigators will also study brain plasticity using Transcranial Magnetic Stimulation (SMT) and Functional Magnetic Resonance Imaging (fMRI). | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Cerebral Vascular Accident | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
66 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 31, 2021 | ||||||||
| Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: Patient :
Volunteers :
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03934073 | ||||||||
| Other Study ID Numbers ICMJE | Centre Hospitalier Sainte Anne | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Centre Hospitalier St Anne | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier St Anne | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Centre Hospitalier St Anne | ||||||||
| Verification Date | August 2018 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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