Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934073
Recruitment Status : Unknown
Verified August 2018 by Centre Hospitalier St Anne.
Recruitment status was:  Recruiting
First Posted : May 1, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier St Anne

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Cerebral Vascular Accident Other: DEXTRAIN Other: CONVENTIONNELLE Other: CONTROLE Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934073


Contacts
Layout table for location contacts
Contact: Jean Louis MAS, PUPH 0145658284 ext 33 jl.mas@ch-sainte-anne.fr
Contact: Sylvie DOROCANT s.dorocant@ch-sainte-anne.fr

Locations
Layout table for location information
France
Centre hospitalier Sainte-Anne Recruiting
Paris, France, 75014
Contact: Pavel LINDBERG, MD       pavel.lindberg@inserm.fr   
Contact: Sylvie DOROCANT       s.dorocant@ch-sainte-anne.fr   
Sponsors and Collaborators
Centre Hospitalier St Anne
Investigators
Layout table for investigator information
Principal Investigator: Jean Louis MAS, PUPH Centre Hospitalier Sainte Anne
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT03934073    
Other Study ID Numbers: Centre Hospitalier Sainte Anne
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases