Parkinson's Disease
Conditions
Interventions
2. Active control
comparison of Treadmill Training alone (TT). To ensure comparable
representation of men and women, randomization allocation will take place
within gender.
After consent, participants will be randomized to one of two arms of the study:
1. Treadmill Training with Virtual Reality (TT+VR)
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients are eligible for participation if they meet all of the following inclusion criteria: - >=2 falls within the 6 months prior to the study - Age range: 60-85 years - Diagnosis of PD (UKBB criteria) - Hoehn and Yahr stage II-III (on medication) - Stable medication for at least one month and anticipated for the next 6 months - Able to walk at least 5 minutes unassisted - Adequate hearing and vision
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: - Psychiatric co-morbidities (e.g., major depression - DSM IV criteria) - Clinical diagnosis of dementia (e.g., Alzheimer*s, vascular, etc.) - History of stroke, traumatic brain injury, brain tumour or other neurological disorders - Acute lower back or lower extremity pain, musculoskeletal injuries, peripheral neuropathy which restricts gait - Unstable medical condition including cardiovascular instability in past 6 months - Unable to comply with training - Cognitively impaired (15 on New Freezing of Gait Questionnaire) - Metal objects or fragments in/on body - Active implant (e.g. pacemaker, neurostimulator, insulin pump) - Epilepsy - Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the change in blood oxygenation level dependent (ΔBOLD) signal in the bilateral anterior putamen during performance of a dual task containing a lower limb motor task and a cognitive task (pre-training vs. post-training assessment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters include the change in blood oxygenation level dependent (ΔBOLD) signal in the bilateral caudate nucleus, the anterior cingulate cortex and the prefrontal cortex, during performance of a dual task containing a lower limb motor task and a cognitive task (pre-training vs. post-training assessment). Other secondary study parameters are prefrontal cortex activation (concentration of oxygenated and deoxygenated heamoglobin) during training and more general walking tasks (dual task walking, obstacle negotiation, walking at preferred speed). Also, magnetic resonance imaging will be used to obtain brain oxygenation levels during ankle movements and a cognitive task, resting state functional connectivity, grey matter volume and white matter integrity. Other secondary study parameters are measures of gait, fall frequency, balance and mobility, community ambulation, cognitive functioning, health related quality of life, fear of falling and user satisfaction of the intervention. A pre-training vs. post training assessment will be used for all secondary study parameters. | — |
Countries
Netherlands
Outcome results
None listed