Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke.

NCT ID: NCT03934073

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2021-04-27

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).

Conditions

Cerebral Vascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

DEXTRAIN

Intervention Type: OTHER

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.

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).

Group Type: ACTIVE_COMPARATOR

CONVENTIONNELLE

Intervention Type: OTHER

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.

Group Type: OTHER

CONTROLE

Intervention Type: OTHER

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)

Interventions

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.

Intervention Type: 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

Intervention Type: 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)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Louis MAS, PUPH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Sainte Anne

Locations

GHU Paris-Psychiatrie & Neurosciences

Paris, , France

Countries

France

References

van Ravestyn C, Gerardin E, Teremetz M, Hamdoun S, Baron JC, Calvet D, Vandermeeren Y, Turc G, Maier MA, Rosso C, Mas JL, Dupin L, Lindberg PG. Post-Stroke Impairments of Manual Dexterity and Finger Proprioception: Their Contribution to Upper Limb Activity Capacity. Neurorehabil Neural Repair. 2024 May;38(5):373-385. doi: 10.1177/15459683241245416. Epub 2024 Apr 4.

Reference Type: DERIVED

PMID: 38572686 (View on PubMed)

Teremetz M, Hamdoun S, Colle F, Gerardin E, Desvilles C, Carment L, Charron S, Cuenca M, Calvet D, Baron JC, Turc G, Maier MA, Rosso C, Mas JL, Lindberg PG. Efficacy of interactive manual dexterity training after stroke: a pilot single-blinded randomized controlled trial. J Neuroeng Rehabil. 2023 Jul 18;20(1):93. doi: 10.1186/s12984-023-01213-9.

Reference Type: DERIVED

PMID: 37464404 (View on PubMed)

Other Identifiers

Centre Hospitalier Sainte Anne

Identifier Type: -

Identifier Source: org_study_id