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Observational Study Evaluating Robotic Spinal Mobilization in 16 Parkinson's Disease Participants. The Study Recorded Changes in Mobility, Sit-to-stand Performance, and Pain Scores After a 2-week Intervention With the BackHug Device.

NCT07384364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2026-03-25

Study results available
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Summary

The goal of this completed observational pilot study was to evaluate the immediate and short-term clinical effects of robotic spinal mobilization on motor and non-motor symptoms in community-dwelling adults with Parkinson's Disease (PD). Specifically, the study aimed to determine if the mechanical release of axial rigidity correlates with measurable improvements in functional mobility, postural stability, and symptom burden.

A cohort of 16 participants (Hoehn and Yahr Stages 1-3) attended four 40-minute therapy sessions using the BackHug device over a two-week period. The device utilizes 26 robotic fingers to deliver targeted deep-tissue mobilization to the paraspinal muscles and intervertebral joints.

Researchers assessed outcomes using a repeated-measures design. Functional mobility and strength were measured immediately before and after sessions to capture acute therapeutic effects. Subjective metrics for chronic back pain and sleep quality were monitored longitudinally to assess cumulative benefits. The study provides preliminary data on the feasibility and efficacy of non-invasive mechanical mobilization as an adjunct therapy for PD.

Conditions

  • Parkinson's Disease (PD)

Sponsors & Collaborators

  • Pacla Medical Limited

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2025-12-10
Completion
2025-12-10

Countries

  • United Kingdom

Study Locations

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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 NCT07384364 on ClinicalTrials.gov