Explorative study: serious games rehabilitation programme to manage gait and balance disorders in patients with Parkinson's disease

Phase 2

Completed

• Conditions: neurologische aandoeningen; gait and balance problems; parkinson's disease

• Registration Number: NL-OMON46570
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

- Diagnosis of probable PD according to the UK Brain Bank Criteria
- Age of >18 years old.
- UPDRS-MDS part II: walking and balance (item 2.12) score >= of 1 and/or Freezing (2.13 item) score of >=1 at screening visit during assessed in *on* medication state
- Relatively stable dopaminergic medication (and relatively stable stimulation parameters in case of a neurostimulator) within last 30 days, or the change in medication does not influence moving (LED change of less than 50% increase or decrease).
- Properly controlled other medical conditions and/or lack of interference with the research protocol.
- Must have access to internet via a computer/laptop at home.

Exclusion Criteria

- Advanced Parkinson*s disease defined as stage 5 according to Hoehn and Yahr (inability to stand up or walk alone).
- Mild Cognitive Impairment or dementia (MMSE < 24).
- Impulse control disorders defined as score >1(inclusively) in item 1.6 of part I MDS-UPDRS.
- Participation in other research study.
- Physical limitation such as incapacitation.
- Severe auditory or visual deficits.
- Computer/laptop does not comply to minimum system requirements of the serious game.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study will difference between groups on the Timed<br /><br>Up & Go test score at week 6 measured in ON medication state. Timed Up & Go<br /><br>test will be videotaped and rated by a blinded investigator. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include motor and non-motor symptoms, gait and balance<br /><br>disorders, cognitive functioning, depression and anxiety, organisational and<br /><br>economic impact, patient and professional experience, safety, tolerance,<br /><br>feasibility, and neurophysiological gait and balance parameters.<br /><br><br /><br>The addition of the 18 week follow up assessment (as secondary endpoint)<br /><br>provides us information about the course of the effect and whether it persists<br /><br>in either those who continue and stop playing the game and the attractiveness<br /><br>of the game.</p><br>