The Effect of Beechband on Parkinson's Symptoms

NCT07821151 | Active Not Recruiting

• 1 other identifier: 12094209
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson's Disease; Vibrotactile stimulation; Wearable device

Outcome Measures

Primary Outcomes (1)

• Modified Unified Parkinson's Disease Rating Scale Motor Score (Modified UPDRS)

  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.

  Baseline, Week 6, and Week 12

Secondary Outcomes (5)

• Timed Up and Go Test Completion Time

  Baseline, Week 6, and Week 12

• Falls Efficacy Scale - International (FES-I)

  Baseline, Week 6, and Week 12

• Visual Sensitivity Scale (VSS)

  Baseline, Week 6, and Week 12

• Gait Specific Attentional Profile (G-SAP)

  Baseline, Week 6, and Week 12

• Generalised Anxiety Scale (GAD-7)

  Baseline, Week 6, and Week 12

Other Outcomes (5)

• Montreal Cognitive Assessment Total Score (MOCA)

  Baseline

• Rapid Assessment of Physical Activity Score (RAPA)

  Every 2 weeks through Week 12

• Self Reported Beechband Use

  Every 2 weeks during the assigned wearing period, through Week 12

Study Arms (2)

Immediate Start Beechband

EXPERIMENTAL

Participants wear the Beechband for approximately 6 hours per day throughout the 12-week study period.

Device: Beechband

Delayed Start Beechband

EXPERIMENTAL

Participants continue their usual activities without wearing the Beechband during the first 6 weeks. They then wear the Beechband for approximately 6 hours per day during Weeks 6-12.

Device: Beechband

Interventions

Beechband DEVICE

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.

Delayed Start Beechband; Immediate Start Beechband

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria
• Able to participate in online video calls

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

University of Exeter

Exeter, Devon, EX4 4QJ, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: The anonymised individual participant data and supporting information will be made available from December 2027, following completion of the study and preparation of the main study findings. The materials will remain available through the repository without a planned end date.
• Access Criteria: Fully anonymised individual participant data and supporting materials will be made openly available through Open Research Exeter (ORE). Researchers and members of the public will be able to access these materials without submitting an application or obtaining approval. Access and reuse will be governed by the repository's terms and the licence assigned to the dataset. Only data from participants who have consented to data sharing will be included. Identifiable information, participant-code linking files, and video recordings will not be shared.

Locations

GB (1)