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

May 2, 2019 updated by: Centre Hospitalier St Anne

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
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).
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
Other: CONTROLE
To compare the results of SMT and functional MRI.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Box and Block test score
Time Frame: one month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier St Anne

Investigators

  • Principal Investigator: Jean Louis MAS, PUPH, Centre Hospitalier Sainte Anne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Centre Hospitalier Sainte Anne

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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