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

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.

Study Overview

• Status: Unknown
• Conditions: Human Spinal Cord Circuitry
• Intervention / Treatment: Other: visual motor tasks

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Nicolas ROCHE, Md PhD
    • Contact: Nicolas Roche, Md, PhD; Phone Number: 0033147105409; Email: roche.nicolas@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: visual motor tasks with dominant arm (1); experimental arm for the first sub-study healthy volunteer
No Intervention: control tasks with dominant arm; control arm for the first sub-study healthy volunteer
No Intervention: visual motor tasks with non-dominant arm; control arm for the second sub-study healthy volunteer
No Intervention: visual motor tasks on dominant arm, flexion movement; experimental arm for the third sub-study healthy volunteer
No Intervention: visual motor tasks on dominant arm, extension movement; experimental arm for the third sub-study healthy volunteer
Experimental: visual motor tasks; fourth sub-study with hemiplegic patient	Other: 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.
No Intervention: visual motor tasks with dominant arm (2); experimental arm for the second sub-study healthy volunteer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hoffmann's reflex amplitude	amplitude modification of the hoffmann's reflex	2h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bell's test	The Bells Test is a cancellation test that allows for a quantitative and qualitative assessment of visual neglect	15 min
kinematic performance of the rhythmic task	task performance, learning task	20 min
modified Ashworth scale	spasticity evaluation	15 min
fugl meyer test	is an index to assess the sensorimotor impairment in individuals who have had stroke	40 min
MRC testing	muscle strengh mesurement	30 min

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2017
• Primary Completion (Actual): July 23, 2018
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hemiplegia; spinal cord circuitry; rhythmic task
• Other Study ID Numbers: 2016-A01190-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No