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 | Completed Results

• 1 other identifier: PM-PD-2025-01
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Parkinson Disease; Axial Rigidity; Robotic Spinal Mobilization; Functional Mobility; Pain; Sleep quality

Outcome Measures

Primary Outcomes (1)

• Percent Change in Functional Mobility (3-Meter Timed Up and Go Test)

  Functional mobility is assessed using the 3-Meter Timed Up and Go (TUG) test. Participants are timed (in seconds) as they rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. This test evaluates gait speed, balance, and functional agility. A decrease in time indicates an improvement in mobility. Results are reported as a percent change from baseline. A negative value indicates a decrease in time, representing an improvement in functional mobility.

  Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).

Secondary Outcomes (3)

• Percent Change in Subjective Back Pain Intensity (Visual Analog Scale) From Baseline

  Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).

• Percent Change in Self-Reported Sleep Quality From Baseline

  Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).

• Percent Change in Functional Lower Limb Strength (30-Second Sit-to-Stand Test)

  Baseline (prior to first intervention) and Post-Intervention (Session 4, approximately 2 weeks post-baseline)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohort was selected from a community-dwelling population in Edinburgh, United Kingdom. Recruitment was conducted at a single specialist physiotherapy centre (The Manual Therapy Clinic) through patient database referrals and local outreach. The population comprised individuals with a confirmed diagnosis of Parkinson's Disease who were living independently in the community and actively seeking non-pharmacological management for motor symptoms

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacla Medical Limited: lead

Study Sites (1)

The Manual Therapy Clinic

Edinburgh, Scotland, EH12 5EH, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Limitations and Caveats

This was a single-arm, open-label pilot study with a small sample size (N=16) intended to generate effect size estimates for future powered trials. The absence of a control group limits the ability to rule out placebo effects or natural symptom fluctuation. Functional assessments were conducted unblinded. Results should be interpreted as preliminary evidence of feasibility and potential efficacy rather than definitive proof of treatment effect.

Results Point of Contact

• Title: Clinical Lead
• Organization: Pacla Medical Limited

support@paclamedical.com

+44, (0)7905771727

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: September 24, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Locations

GB (1)