A Virtual reality-Treadmill combined Intervention for enhancing Mobility and reducing falls in the Elderly (V-TIME)
- Conditions
- 1002803710009841Memory problemsOlder fallersMild Cognitive Impairment (MCI)Parkinson's Disease
- Registration Number
- NL-OMON37232
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Older fallers and patients with MCI are eligible for participation if they meet all of the following inclusion criteria: ;• >=2 falls within the 6 months prior to the study
• Aged 60-85 years
• Able to walk at least 5 minutes unassisted
• Adequate hearing and vision
• Stable medication for >=1 month and anticipated for the next 6 months;The following criteria are specific for either the older fallers or the MCI group.;Specific for the older fallers:
• Clinical Dementia Rating (CDR) score = 0.0;Specific for the patients with MCI:
• Diagnosis of MCI; CDR score = 0.5
Older fallers and patients with MCI 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is fall incidence rate during the 6 month<br /><br>post-training follow-up period, as assessed with a falls calendar. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures include gait, cognition, mobility, health related<br /><br>quality of life and prefrontal activation during walking. </p><br>