Human Spinal Cord CircuitryNCT03094572
Evaluation of the Visual Motor Task's Impact on the Behavior of a Neuronal and Spinal Network in Hemiplegic Patients
A study testing visual motor tasks in people with Human Spinal Cord Circuitry, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The general objective being to determine the modifications nature induced by upper extremity kinematic rhythmic task realization on cervical HSCC. The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured subjects in addition to existing therapeutics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Spinal Cord Circuitry
- What is being tested?
- visual motor tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2017to Feb 2020
- 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
- Hemiplegic subjects:
- Informed consent signature,
- Male or female aged 18 years or over,
- Hemiplegic patient with single stroke,
- Patient able to stand without technical assistance,
- Patient capable of performing an active elbow flexion/extension movement of an amplitude of at least 45° against gravity,
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- Patient able to understand and realize the cyclical kinematic rhythmic task.
- Absence of cognitive impairment, Mini-Mental State score (MMS) equal to 30.
- Voluntary subjects:
- Informed consent signature,
- Male or female aged 18 years or over,
Who cannot join
- Hemiplegic subjects:
- Refusal to participate in the study,
- Inability to cooperate,
- Intervention on the studied upper limb dating less than 6 months,
- No affiliation to a social security scheme,
- No H-reflex in the muscle Flexor Carpi Radialis,
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- Epilepsy antecedent.in the year prior to inclusion.
- Voluntary subjects:
- Refusal to participate in the study,
- Inability to cooperate,
- Intervention on the studied upper limb dating less than 6 months,
- No affiliation to a social security scheme,
- No H-reflex in the Flexor Carpi Radialis muscle,
- Ambidextrous subject,
- Epilepsy antecedent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nicolas ROCHE, Md PhD
Garches, 92380
Nicolas Roche, Md, PhD, 0033147105409, roche.nicolas@aphp.fr
About this study
The general objective being to determine the modifications nature induced by upper extremity kinematic rhythmic task realization on cervical HSCC.
The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured subjects in addition to existing therapeutics.
Read the detailed description
Half of all stroke patients have physical disabilities. These disabilities combine sensory and motor deficiencies (control deficit, syncinesia, tone disorders) that cause disruption of upper extremity (UE) function (orientation, UE length adjustment and grip). The human spinal cord circuitry (HSCC) participate in the motion regulation. Roche et al. studied in healthy subjects the HSCC modifications during the visuo-motor regulation of the object clamping force by the hand. The authors showed that the learning of the task in a single session was associated with HSCC modifications, specific or not depending on the HSCC and according to a visual biofeedback associated or not to the task. Diserens et al. showed also that a rhythmic movement of UE pedaling causes a decrease in spasticity in hemiplegic subjects. Moreover, HSCC modification is dependent on the task performed. The rhythmic ball-bouncing in a virtual environment is a visuo-motor task rhythmic kinematic already studied in the healthy subject. To our knowledge, the present study is the first to investigate HSCC modification in hemiplegic subjects performing a rhythmic kinematic task with UE. We hypothesize that such a task leads to HSCC excitability specific modifications in the cervical spinal cord and leads to an improvement in the motor capabilities of the subjects.
The general objective being to determine the modifications nature induced by UE kinematic rhythmic task realization on cervical HSCC, our research will be broken down into four studies.
Study 1 will identify the influence of visual feedback on changes in HSCC excitability in a voluntary group. In this first study, 16 voluntary subjects will perform the visuo-motor task with their dominant UE and the control task (without visual feedback) with their dominant UE.
Study 2 will investigate the impact of UE laterality which performing the task on changes in HSCC excitability in a voluntary group. In this second study, 16 volunteer subjects will perform the visuo-motor task with their dominant UE and the visuo-motor task with their non-dominant UE.
Study 3 will objectify the effect of the type of contraction of the muscles involved in the task on changes in HSCC excitability in a volunteer group. In this third study, 16 voluntary subjects will perform the visuo-motor task with their dominant UE by performing either elbow flexion-extension or only flexion-extension of the wrist.
Finally, study 4 will study the effect of the pathology and the motor strategies used on the changes in HSCC excitability. In the latter study, 16 hemiplegic patients will perform the visuo-motor task with their paretic UE and spontaneous motor strategies.
The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured subjects in addition to existing therapeutics.
- Conditions
- Human Spinal Cord Circuitry
- Being tested
- visual motor tasks
- Keywords
- spinal cord circuitry, hemiplegia, rhythmic task
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual motor tasksOther
This exercise involves manipulating an object that corresponds to a "racket", this racket has a virtual avatar that animated a virtual ball. The purpose is to make it bounce to a given height. This comes close to ping-pong game.
| Study group | Role | What they receive |
|---|---|---|
| visual motor tasks with dominant arm (1) | No intervention | experimental arm for the first sub-study healthy volunteer |
| control tasks with dominant arm | No intervention | control arm for the first sub-study healthy volunteer |
| visual motor tasks with non-dominant arm | No intervention | control arm for the second sub-study healthy volunteer |
| visual motor tasks on dominant arm, flexion movement | No intervention | experimental arm for the third sub-study healthy volunteer |
| visual motor tasks on dominant arm, extension movement | No intervention | experimental arm for the third sub-study healthy volunteer |
| visual motor tasks | Experimental | fourth sub-study with hemiplegic patient Receives: Other: visual motor tasks |
| visual motor tasks with dominant arm (2) | No intervention | experimental arm for the second sub-study healthy volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hoffmann's reflex amplitude
amplitude modification of the hoffmann's reflex
Measured: 2h
Secondary outcomes (5)
bell's test
The Bells Test is a cancellation test that allows for a quantitative and qualitative assessment of visual neglect
Measured: 15 min
kinematic performance of the rhythmic task
task performance, learning task
Measured: 20 min
modified Ashworth scale
spasticity evaluation
Measured: 15 min
fugl meyer test
is an index to assess the sensorimotor impairment in individuals who have had stroke
Measured: 40 min
MRC testing
muscle strengh mesurement
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start13 Jul 2017
- Primary completion23 Jul 2018
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Spinal Cord CircuitryStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MD PhD, Principal investigator, Raymond Poincare HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094572
- Sponsor's protocol ID
- 2016-A01190-51
- Status last verified
- Jan 2020
- First submitted
- 23 Mar 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Visual Motor Task's Impact on the Behavior of a Neuronal and Spinal Network in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT03094572
- Acronym / sponsor ID
- 2016-A01190-51
- Conditions
- Human Spinal Cord Circuitry
- Keywords
- spinal cord circuitry, hemiplegia, rhythmic task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 29 Mar 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 general objective being to determine the modifications nature induced by upper extremity kinematic rhythmic task realization on cervical HSCC.
The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured subjects in addition to existing therapeutics.
Detailed description
Half of all stroke patients have physical disabilities. These disabilities combine sensory and motor deficiencies (control deficit, syncinesia, tone disorders) that cause disruption of upper extremity (UE) function (orientation, UE length adjustment and grip). The human spinal cord circuitry (HSCC) participate in the motion regulation. Roche et al. studied in healthy subjects the HSCC modifications during the visuo-motor regulation of the object clamping force by the hand. The authors showed that the learning of the task in a single session was associated with HSCC modifications, specific or not depending on the HSCC and according to a visual biofeedback associated or not to the task. Diserens et al. showed also that a rhythmic movement of UE pedaling causes a decrease in spasticity in hemiplegic subjects. Moreover, HSCC modification is dependent on the task performed. The rhythmic ball-bouncing in a virtual environment is a visuo-motor task rhythmic kinematic already studied in the healthy subject. To our knowledge, the present study is the first to investigate HSCC modification in hemiplegic subjects performing a rhythmic kinematic task with UE. We hypothesize that such a task leads to HSCC excitability specific modifications in the cervical spinal cord and leads to an improvement in the motor capabilities of the subjects.
The general objective being to determine the modifications nature induced by UE kinematic rhythmic task realization on cervical HSCC, our research will be broken down into four studies.
Study 1 will identify the influence of visual feedback on changes in HSCC excitability in a voluntary group. In this first study, 16 voluntary subjects will perform the visuo-motor task with their dominant UE and the control task (without visual feedback) with their dominant UE.
Study 2 will investigate the impact of UE laterality which performing the task on changes in HSCC excitability in a voluntary group. In this second study, 16 volunteer subjects will perform the visuo-motor task with their dominant UE and the visuo-motor task with their non-dominant UE.
Study 3 will objectify the effect of the type of contraction of the muscles involved in the task on changes in HSCC excitability in a volunteer group. In this third study, 16 voluntary subjects will perform the visuo-motor task with their dominant UE by performing either elbow flexion-extension or only flexion-extension of the wrist.
Finally, study 4 will study the effect of the pathology and the motor strategies used on the changes in HSCC excitability. In the latter study, 16 hemiplegic patients will perform the visuo-motor task with their paretic UE and spontaneous motor strategies.
The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured subjects in addition to existing therapeutics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| visual motor tasks with dominant arm (1) | No intervention | –experimental arm for the first sub-study healthy volunteer |
| control tasks with dominant arm | No intervention | –control arm for the first sub-study healthy volunteer |
| visual motor tasks with non-dominant arm | No intervention | –control arm for the second sub-study healthy volunteer |
| visual motor tasks on dominant arm, flexion movement | No intervention | –experimental arm for the third sub-study healthy volunteer |
| visual motor tasks on dominant arm, extension movement | No intervention | –experimental arm for the third sub-study healthy volunteer |
| visual motor tasks | Experimental | Other: visual motor tasksfourth sub-study with hemiplegic patient |
| visual motor tasks with dominant arm (2) | No intervention | –experimental arm for the second sub-study healthy volunteer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent signature,
- Male or female aged 18 years or over,
- Hemiplegic patient with single stroke,
- Patient able to stand without technical assistance,
- Patient capable of performing an active elbow flexion/extension movement of an amplitude of at least 45° against gravity,
Key exclusion criteria (15 listed)
- Refusal to participate in the study,
- Inability to cooperate,
- Intervention on the studied upper limb dating less than 6 months,
- No affiliation to a social security scheme,
- No H-reflex in the muscle Flexor Carpi Radialis,
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 |
|---|---|---|
| visual motor tasksThis exercise involves manipulating an object that corresponds to a "racket", this racket has a virtual avatar that animated a virtual ball. The purpose is to make it bounce to a given height. This comes close to ping-pong game. | Other | visual motor tasks |
Primary outcome
Hoffmann's reflex amplitude
Time frame: 2h
amplitude modification of the hoffmann's reflex
5 secondary outcomes
bell's test
Time frame: 15 min
kinematic performance of the rhythmic task
Time frame: 20 min
modified Ashworth scale
Time frame: 15 min
fugl meyer test
Time frame: 40 min
MRC testing
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual motor tasks in people with Human Spinal Cord Circuitry, run by Centre d'Investigation Clinique et Technologique 805 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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas ROCHE, MD PhD (0033147105409, roche.nicolas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hoffmann's reflex amplitude (time frame: 2h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2020.