Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Placebo serious game; Device: Serious game

• Registration Number: NCT03560089
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

To test the effects of a serious game rehabilitation programme in 50 patients with Parkinson's disease with gait and balance disorders in a randomised controlled study

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-18
• Study Start: 2018-07-18
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Parkinson's disease
• Gait and balance disorders resistant to dopaminergic medication

Exclusion Criteria

• dementia
• contra-indication to magnetic resonance imaging

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No active serious game	Placebo serious game	25 patients will not perform motor rehabilitation programme using the serious game
Rehabilitation with active serious game	Serious game	25 patients will perform motor rehabilitation programme using the serious game

Primary Outcome Measures

Name	Time	Method
Duration of the time-up-go test	change between baseline and at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Step length	change between baseline and at 6 weeks
freezing of gait questionnaire	change between baseline and at 6 weeks
Montreal Cognitive Assessment	change between baseline and at 6 weeks
step velocity	change between baseline and at 6 weeks
gait and balance scale	change between baseline and at 6 weeks
Parkinson's disease quality of life scale	change between baseline and at 6 weeks
Magnetic resonance imaging	change between baseline and at 6 weeks
Duration of the time-up-go test	change between baseline and at 18 weeks
Movement disorders Unified Parkinson's disease rating scale	change between baseline and at 6 weeks

Trial Locations

Locations (1)

Centre Investigation Clinique- ICM; 🇫🇷 Paris, France