NCT03094572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

July 13, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

March 23, 2017

Last Update Submit

January 21, 2020

Conditions

Human Spinal Cord Circuitry

Keywords

spinal cord circuitryhemiplegiarhythmic task

Outcome Measures

Primary Outcomes (1)

  • Hoffmann's reflex amplitude

    amplitude modification of the hoffmann's reflex

    2h

Secondary Outcomes (5)

  • bell's test

    15 min

  • kinematic performance of the rhythmic task

    20 min

  • modified Ashworth scale

    15 min

  • fugl meyer test

    40 min

  • MRC testing

    30 min

Study Arms (7)

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

Other: visual motor tasks

visual motor tasks with dominant arm (2)

NO INTERVENTION

experimental arm for the second sub-study healthy volunteer

Interventions

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.

visual motor tasks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nicolas ROCHE, Md PhD

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas ROCHE, MD PhD

    Raymond Poincare HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas ROCHE, MD PhD

CONTACT

0033147105409roche.nicolas@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 29, 2017

Study Start

July 13, 2017

Primary Completion

July 23, 2018

Study Completion

February 1, 2020

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)