Clinical trial NCT03934073: Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Vascular Accident
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Change of Box and Block test score
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: GHU Paris-Psychiatrie & Neurosciences
Study officials:
affiliation: Centre Hospitalier Sainte Anne
name: Jean Louis MAS, PUPH
role: PRINCIPAL_INVESTIGATOR
References: