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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46570

Enrollment

Registered

2018-08-02

Start date

2019-10-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurologische aandoeningen gait and balance problems parkinson's disease

Interventions

Patients will be randomized to receive either rehabilitation with serious game *Toap Run* on the Kinect TM® system (intervention) (n=12 or 13) or similar game performed with the keyboard of the comp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 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.

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study will difference between groups on the Timed Up & Go test score at week 6 measured in ON medication state. Timed Up & Go test will be videotaped and rated by a blinded investigator.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)