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CompletedNCT03166020ERGOTACTUpdated Jun 1, 2020

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

An interventional study of Rehabilitation in Stroke and Motor Activity, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-01.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Motor Activity

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Keywords

  • Serious Game
  • Stroke
  • Rehabilitation
  • Connected objects
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 28 is below the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Severe cognitive disorders preventing the completion of the task
  • Bilateral brain lesions
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Rehabilitation with Interactive Table

    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.

    Other: Rehabilitation

  • Active comparator
    Self 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.

    Other: Rehabilitation

Interventions

  • OtherRehabilitation

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

06

What researchers measure

Primary outcomes

  1. Speed of the gesture to reach each target

    score

    Time frame: 10 minutes

Secondary outcomes

  1. Wolf Motor Functional Test

    Clinical Evaluation

    Time frame: 15 minutes

  2. Box and block

    Clinical Evaluation

    Time frame: 5 minutes

  3. Fugl Meyer

    Clinical Evaluation

    Time frame: 10 minutes

  4. MOCA

    Clinical Evaluation

    Time frame: 5 minutes

  5. Pain

    Visual analog scale

    Time frame: 1 minute

  6. Spasticity

    Visual analog scale

    Time frame: 5 minutes

  7. SF12 Quality of life

    Clinical Evaluation

    Time frame: 10 minutes

  8. Canadian Occupational Performance Measure

    Clinical Evaluation

    Time frame: 20 minutes

  9. Frenchay activities Index

    Clinical Evaluation

    Time frame: 15 minutes

  10. Cinematic Evaluation

    Evaluation of the cinematic of the paretic upper limb

    Time frame: 10 minutes

  11. Clamping force

    composite score

    Time frame: 2 minutes

07

Study locations

2 sites
  • Hopital Raymond Poincare
    Garches, 92380, France
  • Nicolas ROCHE, Md PhD
    Garches, 92380, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03166020
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
Responsible party
Sponsor
First posted
May 24, 2017
Start date
Oct 6, 2017
Primary completion
Nov 7, 2018
Completion
Dec 6, 2018
Last update
Jun 1, 2020

Study contacts

Nicolas ROCHE, MD phD
principal investigator · Raymond Poincare HOSPITAL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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