University of Exeter
Exeter, Devon, EX4 4QJ, United Kingdom
NCT Number: NCT07821151
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.
This study is active but is not currently recruiting participants.
Notify MeAll sexes
Interventional
Not applicable
Exeter, Devon, EX4 4QJ, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 6, and Week 12
Self-reported concern about falling during everyday activities. Higher scores indicate greater concern about falling.
Time frame: Baseline, Week 6, and Week 12
Self-reported symptoms associated with visually complex or moving environments
Time frame: Baseline, Week 6, and Week 12
Self-reported attention directed toward walking and movement.
Time frame: Baseline, Week 6, and Week 12
Seven-item measure of anxiety symptoms, ranging from 0 to 21; higher scores indicate greater anxiety.
Time frame: Baseline
Measure of cognitive function completed remotely, including drawing tasks shown to the researcher by video.
Time frame: Every 2 weeks through Week 12
Self-reported level of physical activity during the preceding two weeks.
Time frame: Every 2 weeks during the assigned wearing period, through Week 12
Average number of hours per day and frequency of Beechband use during the preceding two weeks.
Time frame: Through Week 12
Number and percentage of enrolled participants who withdraw before completing the Week 12 assessment.
Time frame: Every 2 weeks and through Week 12
Number and type of unwanted or unexpected health events reported during the study, including discomfort and dizziness.
University of Exeter
Other
Evaluating Potential Changes in Symptoms Associated With Parkinson's After 6-12 Weeks of Wearing the Beechband
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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