StrokeERGOTACTNCT03166020
Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
A study testing Rehabilitation in people with Stroke and Motor Activity, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites in France.
Trial summary
The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Motor Activity
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Oct 2017to 6 Dec 2018
- 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
- Stroke patients
- Subject with gripping ability: capable of peeling off the connected object from the table, presented in its grip area.
Who cannot join
- Severe cognitive disorders preventing the completion of the task
- Bilateral brain lesions
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Raymond Poincare
Garches, 92380
Nicolas ROCHE, Md PhD
Garches, 92380
About this study
The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation program.
- Conditions
- Stroke, Motor Activity
- Being tested
- Rehabilitation
- Keywords
- Serious Game, Stroke, Rehabilitation, Connected objects
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
An occupational therapist will be required only for patient installation in front of the table.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with Interactive Table | Experimental | Included patients will be invited to participate in 10 sessions, focused on the movement and manipulation of instrumented objects on interactive table with serious game, during 30 minutes per day, 5 days a week, for 14 days. An occupational therapist will be required only for patient installation in front of the table. Receives: Other: Rehabilitation |
| Self Rehabilitation | Active comparator | Included patients will be instructed to perform 10 self-rehabilitation sessions with 9 exercises (3 stretching, 3 reinforcement, 3 spot-oriented work) during 30 minutes per day, 5 days a week, for 14 days. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of the gesture to reach each target
score
Measured: 10 minutes
Secondary outcomes (11)
Wolf Motor Functional Test
Clinical Evaluation
Measured: 15 minutes
Box and block
Clinical Evaluation
Measured: 5 minutes
Fugl Meyer
Clinical Evaluation
Measured: 10 minutes
MOCA
Clinical Evaluation
Measured: 5 minutes
Pain
Visual analog scale
Measured: 1 minute
Spasticity
Visual analog scale
Measured: 5 minutes
SF12 Quality of life
Clinical Evaluation
Measured: 10 minutes
Canadian Occupational Performance Measure
Clinical Evaluation
Measured: 20 minutes
Frenchay activities Index
Clinical Evaluation
Measured: 15 minutes
Cinematic Evaluation
Evaluation of the cinematic of the paretic upper limb
Measured: 10 minutes
Clamping force
composite score
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start6 Oct 2017
- Primary completion7 Nov 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MD phD, Principal investigator, Raymond Poincare HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166020
- Sponsor's protocol ID
- 2016-A01903-48
- Acronym
- ERGOTACT
- Status last verified
- May 2018
- First submitted
- 23 May 2017
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pouplin S, Bonnyaud C, Bouchigny S, Megard C, Bertholier L, Goulamhoussen R, Foulon P, Bensmail D, Barbot F, Roche N. Feasibility of a serious game system including a tangible object for post stroke upper limb rehabilitation: a pilot randomized clinical study. Front Neurol. 2023 Jun 9;14:1176071. doi: 10.3389/fneur.2023.1176071. eCollection 2023.
PubMed 37360348
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
- ClinicalTrials.gov ID
- NCT03166020
- Acronym / sponsor ID
- ERGOTACT / 2016-A01903-48
- Conditions
- Stroke, Motor Activity
- Keywords
- Serious Game, Stroke, Rehabilitation, Connected objects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 24 May 2017 (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.
The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with Interactive Table | Experimental | Other: RehabilitationIncluded patients will be invited to participate in 10 sessions, focused on the movement and manipulation of instrumented objects on interactive table with serious game, during 30 minutes per day, 5 days a week, for 14 days. An occupational therapist will be required only for patient installation in front of the table. |
| Self Rehabilitation | Active comparator | Other: RehabilitationIncluded patients will be instructed to perform 10 self-rehabilitation sessions with 9 exercises (3 stretching, 3 reinforcement, 3 spot-oriented work) during 30 minutes per day, 5 days a week, for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke patients
- Subject with gripping ability: capable of peeling off the connected object from the table, presented in its grip area.
Key exclusion criteria (2 listed)
- Severe cognitive disorders preventing the completion of the task
- Bilateral brain lesions
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 |
|---|---|---|
| RehabilitationAn occupational therapist will be required only for patient installation in front of the table. | Other | Rehabilitation with Interactive Table, Self Rehabilitation |
Primary outcome
Speed of the gesture to reach each target
Time frame: 10 minutes
score
11 secondary outcomes
Wolf Motor Functional Test
Time frame: 15 minutes
Box and block
Time frame: 5 minutes
Fugl Meyer
Time frame: 10 minutes
MOCA
Time frame: 5 minutes
Pain
Time frame: 1 minute
Spasticity
Time frame: 5 minutes
SF12 Quality of life
Time frame: 10 minutes
Canadian Occupational Performance Measure
Time frame: 20 minutes
Frenchay activities Index
Time frame: 15 minutes
Cinematic Evaluation
Time frame: 10 minutes
Clamping force
Time frame: 2 minutes
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 1 Jun 2020.
- Derived from this study: PubMed 37360348Pouplin S, Bonnyaud C, Bouchigny S, Megard C, Bertholier L, Goulamhoussen R, Foulon P, Bensmail D, Barbot F, Roche N. Feasibility of a serious game system including a tangible object for post stroke upper limb rehabilitation: a pilot randomized clinical study. Front Neurol. 2023 Jun 9;14:1176071. doi: 10.3389/fneur.2023.1176071. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Nicolas ROCHE, MD phD principal investigator
Raymond Poincare HOSPITAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Stroke and Motor Activity, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites 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 2 inclusion and 2 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Speed of the gesture to reach each target (time frame: 10 minutes). 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 NCT03166020, which also lists 1 linked publication.
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 1 Jun 2020.