NCT03560089

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2021

Completed
Last Updated

December 4, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

May 15, 2018

Last Update Submit

November 26, 2025

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseGaitRehabilitationSerious game

Outcome Measures

Primary Outcomes (1)

  • Duration of the time-up-go test

    change between baseline and at 6 weeks

Secondary Outcomes (9)

  • Duration of the time-up-go test

    change between baseline and at 18 weeks

  • Step length

    change between baseline and at 6 weeks

  • step velocity

    change between baseline and at 6 weeks

  • Movement disorders Unified Parkinson's disease rating scale

    change between baseline and at 6 weeks

  • freezing of gait questionnaire

    change between baseline and at 6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Rehabilitation with active serious game

ACTIVE COMPARATOR

25 patients will perform motor rehabilitation programme using the serious game

Device: Serious game

No active serious game

PLACEBO COMPARATOR

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

Device: Placebo serious game

Interventions

Serious gameDEVICE

Serious game with movements

Rehabilitation with active serious game
Placebo serious gameDEVICE

Serious game without movement

No active serious game

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • dementia
  • contra-indication to magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Investigation Clinique- ICM

Paris, 75013, France

Location

Related Publications (4)

  • 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.

    PMID: 38588457BACKGROUND

  • 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.

    PMID: 39103924RESULT

  • 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.

    PMID: 37691341RESULT

  • 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.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Marie Laure Welter, PH MD PHD

    ICM, 47 bd de l'Hôpital, 75013 Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded assessment of video
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 18, 2018

Study Start

July 18, 2018

Primary Completion

December 6, 2021

Study Completion

December 6, 2021

Last Updated

December 4, 2025

Record last verified: 2025-05

Locations

FR(1)