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

May 28, 2020 updated by: Centre d'Investigation Clinique et Technologique 805
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré
      • Garches, France, 92380
        • Nicolas ROCHE, Md PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Rehabilitation
An occupational therapist will be required only for patient installation in front of the table.
Active Comparator: 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.
Other: Rehabilitation
An occupational therapist will be required only for patient installation in front of the table.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of the gesture to reach each target
Time Frame: 10 minutes
score
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wolf Motor Functional Test
Time Frame: 15 minutes
Clinical Evaluation
15 minutes
Box and block
Time Frame: 5 minutes
Clinical Evaluation
5 minutes
Fugl Meyer
Time Frame: 10 minutes
Clinical Evaluation
10 minutes
MOCA
Time Frame: 5 minutes
Clinical Evaluation
5 minutes
Pain
Time Frame: 1 minute
Visual analog scale
1 minute
Spasticity
Time Frame: 5 minutes
Visual analog scale
5 minutes
SF12 Quality of life
Time Frame: 10 minutes
Clinical Evaluation
10 minutes
Canadian Occupational Performance Measure
Time Frame: 20 minutes
Clinical Evaluation
20 minutes
Frenchay activities Index
Time Frame: 15 minutes
Clinical Evaluation
15 minutes
Cinematic Evaluation
Time Frame: 10 minutes
Evaluation of the cinematic of the paretic upper limb
10 minutes
Clamping force
Time Frame: 2 minutes
composite score
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

Fondation Garches

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2017

Primary Completion (Actual)

November 7, 2018

Study Completion (Actual)

December 6, 2018

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 24, 2017

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01903-48

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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