NCT02469350

Brief Summary

In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

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 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2017

Completed
Last Updated

November 18, 2025

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

May 28, 2015

Last Update Submit

November 14, 2025

Conditions

Parkinson's Disease

Keywords

Gait and balance disordersserious game

Outcome Measures

Primary Outcomes (1)

  • Feasibility questionnaire

    self-assessment questionnaire

    once a week

Secondary Outcomes (3)

  • Acceptability questionnaire

    once a week

  • biomechanical parameters of gait and balance

    at inclusion, 3 weeks, 6 weeks and 18 weeks

  • kinematics parameters of gait and balance

    at inclusion, 3 weeks, 6 weeks and 18 weeks

Study Arms (1)

Rehabilitation with serious game

EXPERIMENTAL

18 rehabilitation sessions with serious game during a 6-8 weeks period

Other: Serious game

Interventions

Serious gameOTHER

Rehabilitation with serious game

Rehabilitation with serious game

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease
  • Gait and balance disorders
  • Chronic bilateral deep brain stimulation of the subthalamic nucleus (\> 1 year).

You may not qualify if:

  • Dementia
  • Ongoing severe medical condition that prevented assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICM, CIC Neurosciences

Paris, 75013, France

Location

Related Publications (1)

  • Nuic D, Vinti M, Karachi C, Foulon P, Van Hamme A, Welter ML. The feasibility and positive effects of a customised videogame rehabilitation programme for freezing of gait and falls in Parkinson's disease patients: a pilot study. J Neuroeng Rehabil. 2018 Apr 10;15(1):31. doi: 10.1186/s12984-018-0375-x.

    PMID: 29636105RESULT

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, MD, PhD

    GHPS, APHP, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 11, 2015

Study Start

June 1, 2015

Primary Completion

May 4, 2017

Study Completion

October 4, 2017

Last Updated

November 18, 2025

Record last verified: 2017-10

Locations

FR(1)