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

NCT ID: NCT03560089

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2021-12-06

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinded assessment of video

Study Groups

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Rehabilitation with active serious game

25 patients will perform motor rehabilitation programme using the serious game

Group Type ACTIVE_COMPARATOR

Serious game

Intervention Type DEVICE

Serious game with movements

No active serious game

25 patients will not perform motor rehabilitation programme using the serious game

Group Type PLACEBO_COMPARATOR

Placebo serious game

Intervention Type DEVICE

Serious game without movement

Interventions

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Serious game

Serious game with movements

Intervention Type DEVICE

Placebo serious game

Serious game without movement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* dementia
* contra-indication to magnetic resonance imaging
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Laure Welter, PH MD PHD

Role: PRINCIPAL_INVESTIGATOR

ICM, 47 bd de l'Hôpital, 75013 Paris

Locations

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Centre Investigation Clinique- ICM

Paris, , France

Site Status

Countries

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France

References

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Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type BACKGROUND
PMID: 38588457 (View on PubMed)

Skrzatek A, Nuic D, Cherif S, Beranger B, Gallea C, Bardinet E, Welter ML. Brain modulation after exergaming training in advanced forms of Parkinson's disease: a randomized controlled study. J Neuroeng Rehabil. 2024 Aug 5;21(1):133. doi: 10.1186/s12984-024-01430-w.

Reference Type RESULT
PMID: 39103924 (View on PubMed)

Nuic D, van de Weijer S, Cherif S, Skrzatek A, Zeeboer E, Olivier C, Corvol JC, Foulon P, Pastor JZ, Mercier G, Lau B, Bloem BR, De Vries NM, Welter ML. Home-based exergaming to treat gait and balance disorders in patients with Parkinson's disease: A phase II randomized controlled trial. Eur J Neurol. 2024 Jan;31(1):e16055. doi: 10.1111/ene.16055. Epub 2023 Sep 10.

Reference Type RESULT
PMID: 37691341 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

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C17-07

Identifier Type: -

Identifier Source: org_study_id

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