Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Active Arm: Exelon® [Rivastigmine] orally. Uptitration (16 weeks): 1.5mg twice a day for four weeks, 3mg twice day for four weeks, 4.5mg twice day for four weeks, 6mg twice day for four weeks. Main
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with moderate (Hoehn and Yahr stage 2-3) PD. 2. History of having fallen at least once in the last year 3. Participants must be able to walk, without aids, for the length of the walking protocol (approximately 18m) 4. Stable on anti-Parkinsonian medication for 2 weeks prior to enrolment 5. Able to give informed consent and willing to participate
Exclusion criteria
Exclusion criteria: 1. Patients with any other cause [vascular, multisystem atrophy (MSA), progressive supranuclear palsy (PSP), normal pressure hydrocephalus) of Parkinsonism 2. Known diagnosis of dementia 3. Patients with other neurological, visual or orthopaedic problems that significantly interfere with balance or gait 4. Previous or current treatment with a cholinesterase inhibitor or absolute contraindication to cholinesterase inhibitor therapy 5. Inability to attend or comply with treatment or follow-up scheduling 6. Non-English speaking patients, as cognitive tests will be performed in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 01/10/2012 Gait variability (step time variability) with three paradigms: 1.1. Normal walking 1.2. Walking plus verbal fluency 1.3. Walking plus switching at 32 weeks Previous primary outcome measures until 01/10/2012: Gait variability (step time variability) whilst undertaking dual task at 32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/10/2012: 1. Change in harmonic ratios and other spatio-temporal gait parameters (velocity, cadence, step length (cm), stance time, stance time variability, double limb support (% of gait cycle) walk ratio, under three paradigms: 1.1. Normal walking 1.2. Walking plus verbal fluency 1.3. Walking plus task switching 2. Cognition [verbal fluency performance, Montreal Cognitive Assessment (MOCA), Cognitive Failures Questionnaire (CFQ), Test Your Memory (TYM), frontal assessment battery (FAB)] 3. Falls and resultant injuries (number and rate of falls, proportion of fallers in each group, injuries and healthcare resource use) 4. Falls risk factors (visual contrast sensitivity, lower limb proprioception and strength, reaction time, postural sway) 5. Parkinson?s Disease Falls Risk Score 6. Balance in standing (coordinated stability) 7. Fear of falling (Icon-FES) 8. Freezing (FOG questionnaire, and quantification from FOG walking paradigm) 9. Mood (15 item Geriatric Depression Score) 10. Parkinson?s disease symptoms and stage Unified Parkinson's Disease Rating Scale (UPDRS) 11. Quality of life (EQ-5D) 12. Adverse events Previous secondary outcome measures until 01/10/2012: 1. Change in other spatio-temporal gait parameters (velocity, cadence, step length (cm), stance time, stance time variability, double limb support (% of gait cycle) under three paradigms: 1.1. Normal walking 1.2. Walking plus verbal fluency 1.3. Walking plus task switching 8. Freezing (FOG questionnaire, and objective quantification) | — |
Countries
United Kingdom
Outcome results
None listed