Evaluation of the Visual Motor Task's Impact on the Behavior of a Neuronal and Spinal Network in Hemiplegic Patients

NCT ID: NCT03094572

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2020-02-29

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

visual motor tasks with dominant arm (1)

experimental arm for the first sub-study healthy volunteer

Group Type: NO_INTERVENTION

No interventions assigned to this group

control tasks with dominant arm

control arm for the first sub-study healthy volunteer

Group Type: NO_INTERVENTION

No interventions assigned to this group

visual motor tasks with non-dominant arm

control arm for the second sub-study healthy volunteer

Group Type: NO_INTERVENTION

No interventions assigned to this group

visual motor tasks on dominant arm, flexion movement

experimental arm for the third sub-study healthy volunteer

Group Type: NO_INTERVENTION

No interventions assigned to this group

visual motor tasks on dominant arm, extension movement

experimental arm for the third sub-study healthy volunteer

Group Type: NO_INTERVENTION

No interventions assigned to this group

visual motor tasks

fourth sub-study with hemiplegic patient

Group Type: EXPERIMENTAL

visual motor tasks

Intervention Type: OTHER

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.

visual motor tasks with dominant arm (2)

experimental arm for the second sub-study healthy volunteer

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

visual motor tasks

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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,
• 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,

Exclusion Criteria

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,
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas ROCHE, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Raymond Poincare HOSPITAL

Locations

Nicolas ROCHE, Md PhD

Garches, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas ROCHE, MD PhD

Role: CONTACT

roche.nicolas@aphp.fr

0033147105409

Facility Contacts

Nicolas Roche, Md, PhD

Role: primary

roche.nicolas@aphp.fr

0033147105409

Other Identifiers

2016-A01190-51

Identifier Type: -

Identifier Source: org_study_id