eural plasticity in a Virtual reality-Treadmill combined Intervention for enhancing Mobility and reducing falls in Elderly (V-TIME) with Parkinson's Disease

Completed

Conditions: Parkinson's Disease
10028037

Registration Number: NL-OMON36978

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

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

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 (< 24 on Mini-Mental State Examination)
- Interfering therapy, or fall clinic visit <1 month ago
- Severe freezing precluding safe participation (>15 on New Freezing of Gait Questionnaire)
- Metal objects or fragments in/on body
- Active implant (e.g. pacemaker, neurostimulator, insulin pump)
- Epilepsy
- Claustrophobia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in blood oxygenation level dependent<br /><br>(ΔBOLD) signal in the bilateral anterior putamen during performance of a dual<br /><br>task containing a lower limb motor task and a cognitive task (pre-training vs.<br /><br>post-training assessment).</p><br>

Secondary Outcome Measures