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NCT03166020 Clinical Trial

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

Stroke Clinical Trial

— ERGOTACT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03166020
Other study ID # 2016-A01903-48
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 6, 2017
Est. completion date December 6, 2018

Study information
Verified date May 2018
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date December 6, 2018
Est. primary completion date November 7, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital Raymond Poincare Garches
France Nicolas ROCHE, Md PhD Garches

Sponsors (2)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805 Fondation Garches

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Speed of the gesture to reach each target score 10 minutes
Secondary Wolf Motor Functional Test Clinical Evaluation 15 minutes
Secondary Box and block Clinical Evaluation 5 minutes
Secondary Fugl Meyer Clinical Evaluation 10 minutes
Secondary MOCA Clinical Evaluation 5 minutes
Secondary Pain Visual analog scale 1 minute
Secondary Spasticity Visual analog scale 5 minutes
Secondary SF12 Quality of life Clinical Evaluation 10 minutes
Secondary Canadian Occupational Performance Measure Clinical Evaluation 20 minutes
Secondary Frenchay activities Index Clinical Evaluation 15 minutes
Secondary Cinematic Evaluation Evaluation of the cinematic of the paretic upper limb 10 minutes
Secondary Clamping force composite score 2 minutes
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