NCT07384364Completed
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.
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 19 (actual)
- First submitted
- 26 Jan 2026
- Start date
- 24 Sept 2025
- Primary completion date
- 10 Dec 2025
- Lead sponsor
- Pacla Medical Limited
- Diseases
- Parkinson disease
- NCT number
- NCT07384364
What you commit to
- Study type: Observational
- Participants enrolled: 19
- From 24 Sept 2025 to the primary completion date, 10 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Manual Therapy Clinic Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.