Trial results for a study investigating PDVibe2 vibrational therapy for Parkinson's Disease were posted on ClinicalTrials.gov on 2026-03-16, showing an improved Functional Ambulation Profile (FAP) score of 99.2 with the intervention compared to 86.8 without.
Background
Parkinson's Disease (PD) is a progressive neurological disorder that affects movement, often leading to symptoms such as tremors, rigidity, slow movement (bradykinesia), and postural instability. Gait and balance impairments, including freezing of gait (FOG), are particularly challenging symptoms that significantly impact quality of life and increase the risk of falls. Current treatments primarily focus on managing motor symptoms, but innovative approaches to directly address gait and balance issues are continuously being explored. This study investigated the potential of a vibrational therapy device, PDVibe2, to improve these specific motor functions in individuals with PD.
Trial design
This completed study, designated as Phase NA, enrolled 12 participants with Parkinson Disease. The trial evaluated the safety, tolerability, and effect of vibration delivered by an experimental device called PDVibe2 on freezing of gait (FOG), gait, and balance. Participants underwent sessions with the PDVibe2 vibration intervention and sessions without vibration intervention, allowing for a comparison of outcomes.
Key results
The trial reported several key measurements related to functional ambulation, motor symptoms, and mobility:
- Functional Ambulation Profile (FAP) Score (FAP score on a scale):
- PDVibe2 Vibration Intervention Session: Mean of 99.2 (Standard Deviation 6).
- No Vibration Intervention Session: Mean of 86.8 (Standard Deviation 6).
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) (MDS-UPDRS score on scale):
- For one measurement, PDVibe2 Vibration Intervention Session: Mean of 14.1 (Standard Deviation 2.07).
- For the same measurement, No Vibration Intervention Session: Mean of 12.8 (Standard Deviation 2.07).
- For another measurement, PDVibe2 Vibration Intervention Session: Mean of 14.0 (Standard Deviation 2.07).
- For the same measurement, No Vibration Intervention Session: Mean of 13.0 (Standard Deviation 2.07).
- For a third measurement, PDVibe2 Vibration Intervention Session: Mean of 34.6 (Standard Deviation 3.06).
- For the same measurement, No Vibration Intervention Session: Mean of 37.0 (Standard Deviation 3.06).
- For a fourth measurement, PDVibe2 Vibration Intervention Session: Mean of 32.6 (Standard Deviation 3.06).
- For the same measurement, No Vibration Intervention Session: Mean of 31.6 (Standard Deviation 3.06).
- Timed Up and Go (TUG) Test (seconds):
- PDVibe2 Vibration Intervention Session: Mean of 10.5 (Standard Error 1.0).
- No Vibration Intervention Session: Mean of 10.4 (Standard Error 1.0).
What this means
The posted results indicate that the PDVibe2 vibrational therapy may offer benefits for gait in individuals with Parkinson's Disease. Specifically, the Functional Ambulation Profile (FAP) score showed a higher mean value during the PDVibe2 intervention session compared to sessions without vibration, suggesting improved functional ambulation. While some Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) scores showed slight variations between intervention and non-intervention sessions, and the Timed Up and Go (TUG) Test showed minimal difference, the FAP score provides a clear signal of potential improvement in a key area for PD patients. Given the small enrollment of 12 participants, these findings are preliminary and warrant further investigation in larger studies to confirm efficacy and determine clinical significance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03883217, titled "Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease", were posted on 2026-03-16 on clinicaltrials.gov.