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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03934073
Recruitment Status Recruiting
First Posted May 1, 2019
Last update posted May 3, 2019
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.
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).
The DexTrain group sessions will consist of 20 minutes of conventional training followed by 40 minutes of exercises using the DexTrain targeting dexterity components.
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).
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
To compare the results of SMT and functional MRI.
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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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.
Contact: Jean Louis MAS, PUPH 0145658284 ext 33 firstname.lastname@example.org
Contact: Sylvie DOROCANT email@example.com
Centre hospitalier Sainte-Anne
Centre Hospitalier St Anne
Principal Investigator: Jean Louis MAS, PUPH Centre Hospitalier Sainte Anne