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

NCT03166020 — Not applicable, Completed, 28 participants, Centre d'Investigation Clinique et Technologique 805

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Registry	NCT03166020, acronym ERGOTACT
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	28 (Actual)
Sponsor	Centre d'Investigation Clinique et Technologique 805 (Other); collaborators: Fondation Garches
Conditions	Stroke, Motor Activity
Interventions	Rehabilitation (Other)
Dates	start 2017-10-06, primary completion 2018-11-07, completion 2018-12-06, first posted 2017-05-24, last updated 2020-06-01
Locations	2 sites in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Rehabilitation with Interactive Table	Experimental	Other: 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.
Self Rehabilitation	Active comparator	Other: 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 (Other): An occupational therapist will be required only for patient installation in front of the table.

+Outcome measures

Primary outcomes

Speed of the gesture to reach each target [10 minutes]: score

Secondary outcomes

Wolf Motor Functional Test [15 minutes]: Clinical Evaluation
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
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

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (2)

Facility	City	Country	Status
Hopital Raymond Poincare	Garches	France
Nicolas ROCHE, Md PhD	Garches	France

+Publications

Results publication: 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 37360348

+Investigators

Nicolas ROCHE, MD phD, Principal investigator, Raymond Poincare HOSPITAL