Parkinson Disease (PD)
Conditions
Keywords
Parkinson's Disease, Vibrotactile stimulation, Wearable device
Brief summary
Parkinson's disease can affect movement, balance, and everyday activities. The Beechband is a wrist-worn device that provides intermittent vibrations. Some people have reported improvements in symptoms while wearing the device, but there is currently little scientific evidence to support these reports. This pilot study will explore whether movement symptoms and participants' perceptions of their symptoms change after wearing the Beechband for 6 or 12 weeks. Approximately 60 people with Parkinson's disease will be randomly assigned to one of two groups. One group will wear the Beechband for 12 weeks. The other group will continue their usual activities without the Beechband for the first 6 weeks and will then wear it for the following 6 weeks. Participants will be asked to wear the device for approximately 6 hours each day during their assigned wearing period. Assessments will be conducted remotely by video call at the beginning of the study and after 6 and 12 weeks. They will include measures of movement and balance, a timed walking task, and questionnaires about symptoms and everyday experiences. Device use and any unwanted or unexpected effects will also be recorded. The study is intended to estimate the size of any possible changes and assess the feasibility of a future larger clinical trial. It is not designed to provide definitive evidence that the Beechband is effective.
Interventions
DEVICEBeechband
The Beechband is a wrist-worn device that delivers intermittent vibrotactile stimulation. Participants are instructed to wear the device for approximately 6 hours per day during their assigned intervention period, following the manufacturer's guidance. Arm 1: Participants in the IMMEDIATE start arm wear the device for 12 weeks. Arm 2: Participants in the DELAYED start arm wear the device during Weeks 6-12. During selected remote assessments following a Beechband wearing period, movement measures are completed with the device switched on and switched off.
Sponsors
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria * Able to participate in online video calls
Exclusion criteria
* Montreal Cognitive Assessment (MOCA) score below 16 * Previous use of a Beechband, or another vibrating wrist-worn device, for managing symptoms associated with Parkinson's disease * Any neurological diagnosis other than Parkinson's disease that affects cognition or memory, pain, or movement * Pregnant * Significant memory problems that could interfere with the ability to provide informed consent * Unable to stand or walk without assistance for at least 1 minute * Any electronic implant, including deep brain stimulation or a pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Unified Parkinson's Disease Rating Scale Motor Score (Modified UPDRS) | Baseline, Week 6, and Week 12 | Motor symptoms are assessed remotely using the Unified Parkinson's Disease Rating Scale. Items that cannot be assessed reliably by video, including rigidity and postural instability, are omitted. Retained items are scored and summed, with higher scores indicating more severe motor symptoms. Assessments following a Beechband-wearing period also include measurements with the device switched on and switched off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test Completion Time | Baseline, Week 6, and Week 12 | Time in seconds required to stand from a chair, walk 3 metres, turn, return, and sit down. A shorter time indicates better functional mobility. |
| Falls Efficacy Scale - International (FES-I) | Baseline, Week 6, and Week 12 | Self-reported concern about falling during everyday activities. Higher scores indicate greater concern about falling. |
| Visual Sensitivity Scale (VSS) | Baseline, Week 6, and Week 12 | Self-reported symptoms associated with visually complex or moving environments |
| Gait Specific Attentional Profile (G-SAP) | Baseline, Week 6, and Week 12 | Self-reported attention directed toward walking and movement. |
| Generalised Anxiety Scale (GAD-7) | Baseline, Week 6, and Week 12 | Seven-item measure of anxiety symptoms, ranging from 0 to 21; higher scores indicate greater anxiety. |
Countries
United Kingdom
Outcome results
None listed