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

Primary Purpose

Cerebral Vascular Accident

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

DEXTRAIN

CONVENTIONNELLE

CONTROLE

About this trial

This is an interventional treatment trial for Cerebral Vascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Centre hospitalier Sainte-AnneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

DEXTRAIN

CONVENTIONNELLE

CONTROLE

Arm 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.

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).

To compare the results of SMT and functional MRI.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03934073

First Posted

April 29, 2019

Last Updated

May 2, 2019

Sponsor

Centre Hospitalier St Anne

1. Study Identification

Unique Protocol Identification Number

NCT03934073

Brief Title

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

Acronym

DEXTRAIN

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2, 2018 (Actual)

Primary Completion Date

August 31, 2020 (Anticipated)

Study Completion Date

August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Vascular Accident

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DEXTRAIN

Arm Type

Experimental

Arm 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.

Arm Title

CONVENTIONNELLE

Arm Type

Active Comparator

Arm Description

Arm Title

CONTROLE

Arm Type

Other

Arm Description

To compare the results of SMT and functional MRI.

Intervention Type

Other

Intervention Name(s)

DEXTRAIN

Intervention Description

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

Intervention Name(s)

CONVENTIONNELLE

Intervention Description

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

Intervention Name(s)

CONTROLE

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change of Box and Block test score

Description

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean Louis MAS, PUPH

Phone

0145658284

Ext

jl.mas@ch-sainte-anne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sylvie DOROCANT

s.dorocant@ch-sainte-anne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Louis MAS, PUPH

Organizational Affiliation

Centre Hospitalier Sainte Anne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre hospitalier Sainte-Anne

City

Paris

ZIP/Postal Code

75014

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pavel LINDBERG, MD

pavel.lindberg@inserm.fr

First Name & Middle Initial & Last Name & Degree

Sylvie DOROCANT

s.dorocant@ch-sainte-anne.fr

12. IPD Sharing Statement

Learn more about this trial

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

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