Cerebral Vascular AccidentDEXTRAINNCT03934073
Evaluation of the Benefit of the Training of the Manual Dexterity Post Stroke.
A study testing DEXTRAIN and CONVENTIONNELLE in people with Cerebral Vascular Accident, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Vascular Accident
- What is being tested?
- DEXTRAIN and CONVENTIONNELLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2018to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- DEXTRAIN, CONVENTIONNELLE, CONTROLE
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXTRAINOther
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.
CONVENTIONNELLEOther
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
CONTROLEOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: CONVENTIONNELLE |
| CONTROLE | Other | To compare the results of SMT and functional MRI. Receives: Other: CONTROLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start2 Feb 2018
- Primary completion31 Aug 2020
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Vascular AccidentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Louis MAS, PUPH, Principal investigator, Centre Hospitalier Sainte Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934073
- Sponsor's protocol ID
- Centre Hospitalier Sainte Anne
- Acronym
- DEXTRAIN
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2019
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38572686Teremetz 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.
PubMed 37464404
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03934073
- Acronym / sponsor ID
- DEXTRAIN / Centre Hospitalier Sainte Anne
- Conditions
- Cerebral Vascular Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DEXTRAIN | Experimental | Other: DEXTRAINThe DexTrain group sessions will consist of 20 minutes of conventional training followed by 40 minutes of exercises using the DexTrain targeting dexterity components. |
| CONVENTIONNELLE | Active comparator | Other: CONVENTIONNELLEConventional 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). |
| CONTROLE | Other | Other: CONTROLETo compare the results of SMT and functional MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- At least 18 years old
Key exclusion criteria (5 listed)
- Significant disability or pre-existing deficiency that may interfere with study-specific assessments:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXTRAIN12 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. | Other | DEXTRAIN |
| CONVENTIONNELLE12 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 | CONVENTIONNELLE |
| CONTROLEOnly 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) | Other | CONTROLE |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 38572686van 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.
- Derived from this study: PubMed 37464404Teremetz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Louis MAS, PUPH principal investigator
Centre Hospitalier Sainte Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEXTRAIN and CONVENTIONNELLE in people with Cerebral Vascular Accident, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Box and Block test score (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934073, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.