Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident
ERGOTACT
1 other identifier
interventional
28
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Oct 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedStudy Start
First participant enrolled
October 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2018
CompletedJune 1, 2020
May 1, 2018
1.1 years
May 23, 2017
May 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Speed of the gesture to reach each target
score
10 minutes
Secondary Outcomes (11)
Wolf Motor Functional Test
15 minutes
Box and block
5 minutes
Fugl Meyer
10 minutes
MOCA
5 minutes
Pain
1 minute
- +6 more secondary outcomes
Study Arms (2)
Rehabilitation with Interactive Table
EXPERIMENTALIncluded 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.
Self Rehabilitation
ACTIVE COMPARATORIncluded 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.
Interventions
An occupational therapist will be required only for patient installation in front of the table.
Eligibility Criteria
You may qualify if:
- Stroke patients
- Subject with gripping ability: capable of peeling off the connected object from the table, presented in its grip area.
You may not qualify if:
- Severe cognitive disorders preventing the completion of the task
- Bilateral brain lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hopital Raymond Poincare
Garches, 92380, France
Nicolas ROCHE, Md PhD
Garches, 92380, France
Related Publications (1)
Pouplin S, Bonnyaud C, Bouchigny S, Megard C, Bertholier L, Goulamhoussen R, Foulon P, Bensmail D, Barbot F, Roche N. Feasibility of a serious game system including a tangible object for post stroke upper limb rehabilitation: a pilot randomized clinical study. Front Neurol. 2023 Jun 9;14:1176071. doi: 10.3389/fneur.2023.1176071. eCollection 2023.
PMID: 37360348DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas ROCHE, MD phD
Raymond Poincare HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 24, 2017
Study Start
October 6, 2017
Primary Completion
November 7, 2018
Study Completion
December 6, 2018
Last Updated
June 1, 2020
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share