Back to resultsEvaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident (ERGOTACT)
Primary Purpose
Stroke, Motor Activity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring Serious Game, Stroke, Rehabilitation, Connected objects
Eligibility 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
Sites / Locations
- Hopital Raymond Poincare
- Nicolas ROCHE, Md PhD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehabilitation with Interactive Table
Self Rehabilitation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Speed of the gesture to reach each target
score
Secondary Outcome Measures
Wolf Motor Functional Test
Clinical Evaluation
Box and block
Clinical Evaluation
Fugl Meyer
Clinical Evaluation
MOCA
Clinical Evaluation
Pain
Visual analog scale
Spasticity
Visual analog scale
SF12 Quality of life
Clinical Evaluation
Canadian Occupational Performance Measure
Clinical Evaluation
Frenchay activities Index
Clinical Evaluation
Cinematic Evaluation
Evaluation of the cinematic of the paretic upper limb
Clamping force
composite score
Full Information
NCT ID
NCT03166020
First Posted
May 23, 2017
Last Updated
May 28, 2020
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
1. Study Identification
Unique Protocol Identification Number
NCT03166020
Brief Title
Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
Acronym
ERGOTACT
Official Title
Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Motor Activity
Keywords
Serious Game, Stroke, Rehabilitation, Connected objects
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation with Interactive Table
Arm Type
Experimental
Arm Description
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.
Arm Title
Self Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
An occupational therapist will be required only for patient installation in front of the table.
Primary Outcome Measure Information:
Title
Speed of the gesture to reach each target
Description
score
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Wolf Motor Functional Test
Description
Clinical Evaluation
Time Frame
15 minutes
Title
Box and block
Description
Clinical Evaluation
Time Frame
5 minutes
Title
Fugl Meyer
Description
Clinical Evaluation
Time Frame
10 minutes
Title
MOCA
Description
Clinical Evaluation
Time Frame
5 minutes
Title
Pain
Description
Visual analog scale
Time Frame
1 minute
Title
Spasticity
Description
Visual analog scale
Time Frame
5 minutes
Title
SF12 Quality of life
Description
Clinical Evaluation
Time Frame
10 minutes
Title
Canadian Occupational Performance Measure
Description
Clinical Evaluation
Time Frame
20 minutes
Title
Frenchay activities Index
Description
Clinical Evaluation
Time Frame
15 minutes
Title
Cinematic Evaluation
Description
Evaluation of the cinematic of the paretic upper limb
Time Frame
10 minutes
Title
Clamping force
Description
composite score
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas ROCHE, MD phD
Organizational Affiliation
Raymond Poincare HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Nicolas ROCHE, Md PhD
City
Garches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
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