The primary objective is to evaluate the efficacy of the serious game *Toap Run* on gait and balance outcomes in patients with PD. Secondary objectives include assessing the effects of the game on disease symptoms, spatiotemporal gait parameter and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neurologische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Parkinson*s disease (PD) is a neurodegenerative disorder with many motor- and
non-motor symptoms. People with Parkinson (PwP) fall frequently during the
course of the disease. This can have tremendous and serious consequences, like
an increase in disability, reduced quality of life and hospital admission.
Rehabilitation in PD has been shown to play an important role in the reduction
falls and fall risk. Recent technological advances make it possible to
introduce individualized, home-based exercise in virtual reality games
specifically designed for PwP, including fallers. Preliminary evidence in a
small pilot study with 10 people showed good acceptability and feasibility of a
serious game with a 'Toap Run' developed for PD, with potential benefits on
falls and freezing of gait.
Study objective
The primary objective is to evaluate the efficacy of the serious game *Toap
Run* on gait and balance outcomes in patients with PD. Secondary objectives
include assessing the effects of the game on disease symptoms, spatiotemporal
gait parameter and quality of life. Moreover, the impact of this program on
health economics will be also evaluated.
Study design
We will perform an explorative single - blind randomised controlled trial with
active control arm. Patients (n=25) will be included in France (Brain and Spine
Institute- we will ask for local ethical approval) and The Netherlands
(Radboudumc, n=25). Patients will be equally allocated to 2 parallel groups
either receiving balance training using the serious game *Toap Run* or to a
active control control group for 6 weeks. Measurements will be performed at
three timepoints by a blinded rater.
Intervention
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 computer (active control group)) (n=12 or
13). Toap Run will be personalised for the subjects using a Kinect via a brief
in-game gait and balance test. For subjects without Kinect (for example
controls), the difficulty level will be raised in accordance with a standard
training protocol.
Study burden and risks
Subjects are assessed at three moments: baseline, week 6 and week 18 (follow-
up). This assessment takes about 4 hours each time to complete. They are
required to keep a fall journal, which may cost a minute a day to fill out. All
of the intervention and control group subjects are required to play the game
for at least 6 weeks in a row for at least 2:15 hours a week. We may encounter
two types of risks: physical injury and/or gaming addiction. The possible
benefits for participants are improvements in gait and balance functions, as
well as improvements in quality of life. The total burden will be about 30
hours, plus the additional play time after the first follow-up assessment.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64775.091.18 |