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Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease

NCT07376122 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-30

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson's Disease (PD)

Interventions

DEVICE

BackHug Robotic Spinal Mobilization System

Participants will receive spinal mobilization therapy using the BackHug Robotic System. The device comprises a treatment bed with 26 robotic therapeutic heads ('fingers') that deliver targeted mechanical pressure to the paraspinal muscles and intervertebral joints of the cervical, thoracic, and lumbar spine. The mechanism is designed to mobilize stiff spinal segments and reduce paraspinal muscle tension (axial rigidity). Protocol: Regimen: Four (4) sessions administered over a two-week period. Duration: 40 minutes per session. Personalization: Treatment intensity and speed are adjusted to individual user tolerance via the device's control app, while maintaining a standardized focus on the full spine. Mechanism: Real-time load sensing adapts pressure to the user's specific spinal curvature.

Sponsors & Collaborators

  • Pacla Medical Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2026-11-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376122 on ClinicalTrials.gov