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

NCT03934073 | Completed

• 1 other identifier: Centre Hospitalier Sainte Anne
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Vascular Accident

Outcome Measures

Primary Outcomes (1)

• Change of Box and Block test score

  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.

  one month

Study Arms (3)

DEXTRAIN

EXPERIMENTAL

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

CONVENTIONNELLE

ACTIVE COMPARATOR

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

CONTROLE

OTHER

To compare the results of SMT and functional MRI.

Other: CONTROLE

Interventions

DEXTRAIN 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.

DEXTRAIN

CONVENTIONNELLE 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

CONVENTIONNELLE

CONTROLE 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)

CONTROLE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient :
• At least 18 years old
• st 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,

You may not qualify if:

• 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)
• Another severe disease making follow-up difficult.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris-Psychiatrie & Neurosciences

Paris, 75014, France

Location

Related Publications (2)

• 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.

  PMID: 38572686 DERIVED

• 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.

  PMID: 37464404 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean Louis MAS, PUPH

  Centre Hospitalier Sainte Anne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: February 2, 2018
• Primary Completion: August 31, 2020
• Study Completion: April 27, 2021
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

FR (1)