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Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease

NCT07376122 · Pacla Medical Limited · Updated 30 Jan 2026

What is being tested
BackHug Robotic Spinal Mobilization System
For
Parkinson's Disease (PD)
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 75 years. About 30 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started 9 March 2026, ends Nov 2026. Registered 29 Jan 2026.
Results
None posted yet.

In the researchers' words

This interventional pilot study will evaluate the safety and clinical efficacy of robotic spinal mobilization in community-dwelling adults with Parkinson's Disease (PD). The primary objective is to determine if the mechanical release of axial rigidity using the BackHug device correlates with measurable improvements in functional mobility and postural stability. Participants will be prospectively recruited and assigned to receive a standardized course of robotic therapy. The intervention consists of a series of 40-minute sessions administered over a defined observation period. The device features 26 robotic therapeutic heads designed to deliver targeted deep-tissue mobilization to the paraspinal muscles and intervertebral joints of the thoracic and lumbar spine. Key outcomes will be assessed using a repeated-measures design. Functional mobility (3-Meter Timed Up and Go) and functional strength (30-Second Sit-to-Stand) will be measured immediately before and after specific sessions to quantify acute therapeutic effects. Additionally, subjective metrics for chronic back pain (VAS) and sleep quality will be monitored to assess longitudinal benefits. This study aims to validate non-invasive mechanical mobilization as a scalable adjunct therapy for managing the 'axial' symptoms of Parkinson's Disease.
ClinicalTrials.gov, NCT07376122