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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02469350
Other study ID # C15-12
Secondary ID RCB
Status Completed
Phase N/A
First received May 28, 2015
Last updated October 31, 2017
Start date June 2015
Est. completion date October 4, 2017

Study information

Verified date October 2017
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 4, 2017
Est. primary completion date May 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Parkinson's disease

- Gait and balance disorders

- Chronic bilateral deep brain stimulation of the subthalamic nucleus (> 1 year).

Exclusion Criteria:

- Dementia

- Ongoing severe medical condition that prevented assessments

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Serious game
Rehabilitation with serious game

Locations

Country Name City State
France ICM, CIC Neurosciences Paris

Sponsors (1)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility questionnaire self-assessment questionnaire once a week
Secondary Acceptability questionnaire self-assessment questionnaire once a week
Secondary biomechanical parameters of gait and balance recordings of centres of foot and mass displacements and velocities at inclusion, 3 weeks, 6 weeks and 18 weeks
Secondary kinematics parameters of gait and balance range of motion of hip, knee and ankle angles at inclusion, 3 weeks, 6 weeks and 18 weeks
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