Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident

NCT ID: NCT03166020

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2018-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Motor Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Rehabilitation with Interactive Table

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.

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type OTHER

An occupational therapist will be required only for patient installation in front of the table.

Self Rehabilitation

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.

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

An occupational therapist will be required only for patient installation in front of the table.

Interventions

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Rehabilitation

An occupational therapist will be required only for patient installation in front of the table.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stroke patients
* Subject with gripping ability: capable of peeling off the connected object from the table, presented in its grip area.

Exclusion Criteria

* Severe cognitive disorders preventing the completion of the task
* Bilateral brain lesions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Garches

OTHER

Sponsor Role collaborator

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas ROCHE, MD phD

Role: PRINCIPAL_INVESTIGATOR

Raymond Poincare HOSPITAL

Locations

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Hopital Raymond Poincare

Garches, , France

Site Status

Nicolas ROCHE, Md PhD

Garches, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 37360348 (View on PubMed)

Other Identifiers

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2016-A01903-48

Identifier Type: -

Identifier Source: org_study_id

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