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

Not Applicable

Completed

• Conditions: Motor Activity; Stroke
• Interventions: Other: Rehabilitation

• Registration Number: NCT03166020
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Study Start: 2017-10-06
• Status Verified: 2018-05
• Primary Completion: 2018-11-07
• Study Completion: 2018-12-06
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self Rehabilitation	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.
Rehabilitation with Interactive Table	Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Speed of the gesture to reach each target	10 minutes	score

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hopital Raymond Poincare; 🇫🇷 Garches, France

Nicolas ROCHE, Md PhD; 🇫🇷 Garches, France