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

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ClinicalTrials.gov Identifier: NCT03166020
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Fondation Garches
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Motor Activity Other: Rehabilitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Amplitude and speed of the gesture to reach each target [ Time Frame: 10 minutes ]
    composite score


Secondary Outcome Measures :
  1. Wolf Motor Functional Test [ Time Frame: 15 minutes ]
    Clinical Evaluation

  2. Box and block [ Time Frame: 5 minutes ]
    Clinical Evaluation

  3. Fugl Meyer [ Time Frame: 10 minutes ]
    Clinical Evaluation

  4. MOCA [ Time Frame: 5 minutes ]
    Clinical Evaluation

  5. Pain [ Time Frame: 1 minute ]
    Visual analog scale

  6. Satisfaction [ Time Frame: 1 minute ]
    Visual analog scale

  7. Spasticity [ Time Frame: 5 minutes ]
    Visual analog scale

  8. SF12 Quality of life [ Time Frame: 10 minutes ]
    Clinical Evaluation

  9. Canadian Occupational Performance Measure [ Time Frame: 20 minutes ]
    Clinical Evaluation

  10. Frenchay activities Index [ Time Frame: 15 minutes ]
    Clinical Evaluation

  11. Cinematic Evaluation [ Time Frame: 10 minutes ]
    Evaluation of the cinematic of the paretic upper limb

  12. Clamping force [ Time Frame: 2 minutes ]
    composite score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166020


Contacts
Contact: Nicolas ROCHE, MDphD 0033147105409 nicolas.roche@aphp.fr

Locations
France
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: ROCHE Nicolas, MDPHD    0147107900    roche.nicolas@rpc.aphp.fr   
Contact: POTTIER Sandra, CRA    0147104469    sandra.pottier@rpc.aphp.fr   
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: Nicolas ROCHE, MDPHD    (33)147105409    roche.nicolas@rpc.aphp.fr   
Contact: Sandra POTTIER, CRA    (33)147104469    sandra.pottier@rpc.aphp.fr   
Nicolas ROCHE, Md PhD Recruiting
Garches, France, 92380
Contact: Nicolas Roche, Md, PhD    0033147105409    roche.nicolas@aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Fondation Garches
Investigators
Principal Investigator: Nicolas ROCHE, MD phD Raymond Poincare HOSPITAL

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03166020     History of Changes
Other Study ID Numbers: 2016-A01903-48
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Serious Game
Stroke
Rehabilitation
Connected objects

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases