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.
CompletedNCT07384364
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Prospective, Single-Arm, Observational Case Series Evaluation of the Impact of Robotic Spinal Mobilization on Functional Mobility, Axial Rigidity, Chronic Back Pain, and Sleep Quality in Community-Dwelling Adults With Parkinson's Disease
- Conditions
- Parkinson's Disease (PD)
- Sponsor
- Pacla Medical Limited
- Start date
- 2025-09-24
- Primary completion
- 2025-12-10
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis: Confirmed clinical diagnosis of Parkinson's Disease. * Disease Severity: Hoehn and Yahr Scale Stage 3 or below (indicating mild to moderate disability with preserved postural reflexes). * Functional Mobility: Ability to walk independently for approximately 5 minutes. Use of walking poles is permitted; reliance on a walking frame (Zimmer frame) or wheelchair excludes participation. * Consent: Willing and able to provide informed consent and attend all four scheduled therapy sessions. Exclusion Criteria: * Spinal \& Bone Pathology: Diagnosis of spinal malignancy (benign or malignant tumors), active spinal infection (e.g., tuberculosis), severe congenital defects (dysplasia), metabolic bone disease (e.g., severe osteomalacia), or currently healing spinal fractures/dislocations. * Inflammatory Conditions: Severe Rheumatoid Arthritis or other inflammatory arthritides causing potential spinal instability. * Neurological Contraindications (Non-PD): Evidence of spinal cord compression, spinal cord damage, or Cauda Equina syndrome. * Vascular \& Hematological Risks: History of aortic dysfunction (e.g., abdominal aortic aneurysm, blood clot), severe haemophilia, or unmanaged bleeding disorders. * Other: Current pregnancy; History of active cancer (excluding localized squamous cell carcinoma); Recent spinal surgery.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07384364