Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease

NCT07376122 | Not Yet Recruiting

• 1 other identifier: PM-PD-2026-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Axial Rigidity, Spinal Mobilization, Robotic Therapy, Chronic Pain, Sleep Quality, Gait Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Functional Mobility (Gait Speed and Agility)

  Functional mobility is assessed using the Timed Up and Go (TUG) Test (or a similar timed walking task). Participants are timed (in seconds) as they rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. A shorter time indicates better mobility and reduced bradykinesia.

  Baseline and 4 weeks.

Secondary Outcomes (3)

• Change in Subjective Back Pain Intensity

  Baseline and 4 weeks.

• Change in Self-Reported Sleep Quality

  Baseline and 4 weeks.

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

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

Study Arms (1)

Experimental: BackHug Robotic Therapy

EXPERIMENTAL

Device: BackHug Robotic Spinal Mobilization System

Interventions

BackHug Robotic Spinal Mobilization System DEVICE

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.

Experimental: BackHug Robotic Therapy

Eligibility Criteria

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

You may qualify if:

• Diagnosis: Participants must have a confirmed clinical diagnosis of Parkinson's Disease.
• Disease Severity: Hoehn and Yahr Scale Stage 3 or below (indicating mild to moderate disability; capable of independent balance).
• Functional Mobility: Ability to walk independently for approximately 5 minutes. Use of walking poles is permitted; however, reliance on a walking frame (Zimmer frame) or wheelchair excludes participation.
• Age: 18 to 80 years.

You may not qualify if:

• Participants are excluded if they present with any absolute contraindication to mechanical spinal mobilization, including:
• Spinal Pathology \& Trauma: History of spinal malignancy (benign or malignant tumors), active spinal infection (e.g., tuberculosis), severe congenital defects (dysplasia), or currently healing spinal fractures/dislocations.
• Metabolic \& Inflammatory Bone Disease: Diagnosed severe Osteomalacia or severe Rheumatoid Arthritis (due to ligamentous instability risk).
• Neurological Contraindications (Non-PD): Evidence of spinal cord compression, Cauda Equina syndrome, or other serious neurological conditions causing spinal instability or loss of sensation.
• Vascular \& Hematological Risks: History of aortic dysfunction (e.g., abdominal aortic aneurysm), severe haemophilia, or unmanaged coagulation disorders causing bleeding into joints.

Sponsors & Collaborators

• Pacla Medical Limited: lead

Related Publications (3)

• Seckinogullari B, Balkan AF, Cakmakli GY, Aksoy S, Elibol B. Acute effects of lumbosacral mobilization on balance and functional activities in idiopathic Parkinson's disease:A randomised controlled trial. Neurol Res. 2023 Aug;45(8):745-752. doi: 10.1080/01616412.2023.2203613. Epub 2023 Apr 17.

  PMID: 37068206 RESULT

• Yang WC, Hsu WL, Wu RM, Lu TW, Lin KH. Motion analysis of axial rotation and gait stability during turning in people with Parkinson's disease. Gait Posture. 2016 Feb;44:83-8. doi: 10.1016/j.gaitpost.2015.10.023. Epub 2015 Nov 9.

  PMID: 27004637 RESULT

• Van Emmerik RE, Wagenaar RC, Winogrodzka A, Wolters EC. Identification of axial rigidity during locomotion in Parkinson disease. Arch Phys Med Rehabil. 1999 Feb;80(2):186-91. doi: 10.1016/s0003-9993(99)90119-3.

  PMID: 10025495 RESULT

MeSH Terms

Conditions

Parkinson Disease; Chronic Pain; Sleep Initiation and Maintenance Disorders; Mobility Limitation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chongsu Lee, MSc, MCSP, BEng

CONTACT

+447905771727; chongsu@paclamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR