Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke. (DEXTRAIN)

Centre Hospitalier St Anne

Status: Completed

Conditions: Cerebral Vascular Accident

Treatments: Other: CONVENTIONNELLE; Other: DEXTRAIN; Other: CONTROLE

Study type: Interventional

Funder types: Other

Identifiers

NCT03934073

Centre Hospitalier Sainte Anne

Details and patient eligibility

About

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.

Full 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).

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 3 patient groups

DEXTRAIN

Experimental group

Description:

The DexTrain group sessions will consist of 20 minutes of conventional training followed by 40 minutes of exercises using the DexTrain targeting dexterity components.

Treatment:

Other: DEXTRAIN

CONVENTIONNELLE

Active Comparator group

Description:

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).

Treatment:

Other: CONVENTIONNELLE

CONTROLE

Other group

Description:

To compare the results of SMT and functional MRI.

Treatment:

Other: CONTROLE