Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease

January 28, 2026 updated by: Pacla Medical Limited

A Prospective, Single-Arm Pilot Study Evaluating the Effect of Robotic Spinal Mobilization (BackHug) on Mobility, Pain, and Sleep in Parkinson's Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Rationale: Axial rigidity is a cardinal motor feature of Parkinson's Disease (PD), characterized by stiffness in the trunk and spine. This symptom contributes significantly to gait impairment, balance dysfunction, and chronic pain, yet often shows limited response to standard dopaminergic medication. This interventional study will investigate the utility of the BackHug robotic device to mechanically mobilize the thoracic and lumbar spine, evaluating the hypothesis that reducing axial stiffness improves systemic mobility.

Study Design: This is a prospective, single-arm, open-label interventional pilot study.

The Intervention (BackHug): Participants will be assigned to receive therapy on the BackHug device.

Duration: 40 minutes per session.

Mechanism: 26 robotic fingers delivering targeted pressure to the paraspinal muscles.

Settings: Intensity and speed will be personalized to user tolerance but standardized to target the neck, shoulders, and full back.

Eligibility Criteria:

Inclusion: Adults (18-75) with confirmed PD; Hoehn and Yahr Stages 1-3; Ability to walk independently for 5 minutes.

Exclusion: Serious bone pathology (malignancy, infection, severe osteoporosis/osteomalacia); Inflammatory arthritides; Non-PD neurological conditions (spinal cord compression); Vascular risks (aortic aneurysm).

Study Protocol:

Screening & Baseline: Candidates will undergo safety screening against contraindications. Baseline functional metrics (TUG, STS) and subjective scores (VAS, Sleep) will be recorded.

Intervention Phase:

Pre-Therapy Testing: Functional tests performed immediately prior to therapy.

Therapy Administration: Automated robotic mobilization session.

Post-Therapy Testing: Functional tests repeated immediately post-session to capture acute motor changes.

Follow-up: Final assessments will be conducted at the end of the protocol to evaluate short-term retention of benefits.

Outcome Measures:

Primary: Change in Functional Mobility via 3-Meter Timed Up and Go (TUG).

Secondary: Change in Functional Strength via 30-Second Sit-to-Stand (STS); Change in Pain Intensity via VAS (0-10); Change in Sleep Quality via Likert Scale.

Exploratory: Proprioception and fine motor control (Finger-Nose, Toe Tapping).

Quality Assurance & Data Management Plan:

Data Validation: All functional assessments will be administered by trained clinical staff using standardized protocols to ensure inter-rater reliability.

Source Data Verification: Primary data will be recorded on source documents (Case Report Forms). Where consent is granted, video recordings of functional tests will serve as source data for timing verification.

Data Checks: The electronic database will employ logic checks (e.g., range limits for Age and VAS scores) to prevent data entry errors.

Missing Data Plan: The study will utilize a Last Observation Carried Forward (LOCF) approach for minor missing data points, or conduct analysis on a Per-Protocol basis for the primary endpoint.

Statistical Analysis Plan:

Sample Size: The study aims to recruit a cohort sufficient to generate effect size estimates for a future randomized controlled trial.

Analysis: Paired t-tests (or Wilcoxon signed-rank tests for non-parametric data) will be used to compare Pre- vs. Post-intervention scores. Descriptive statistics will summarize demographic baseline characteristics.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

The study population consists of community-dwelling adults (aged 18-80) with a confirmed diagnosis of Parkinson's Disease. Participants present with mild to moderate disease severity (Hoehn and Yahr Stages 1-3) and retain the ability to ambulate independently. The cohort is recruited primarily through clinical referral and direct-to-patient outreach, comprising individuals specifically seeking non-pharmacological management for axial rigidity and associated motor symptoms.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: BackHug Robotic Therapy
Device: BackHug Robotic Spinal Mobilization System

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Mobility (Gait Speed and Agility)
Time Frame: Baseline and 4 weeks.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subjective Back Pain Intensity
Time Frame: Baseline and 4 weeks.
Participants self-report their current level of back pain or discomfort using the Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst possible pain.
Baseline and 4 weeks.
Change in Self-Reported Sleep Quality
Time Frame: Baseline and 4 weeks.

Participants rate their overall quality of sleep using a 5-point Likert scale. The scale ranges from 0 to 5, where:

5 = Very Poor (Frequent waking, discomfort)

0 = Excellent (Uninterrupted, restful sleep) Higher scores indicate an improvement in sleep quality.
Baseline and 4 weeks.
Change in Functional Lower Limb Strength (30-Second Sit-to-Stand Test)'
Time Frame: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later)
Participants are instructed to sit in a chair with arms crossed over their chest and then stand up and sit down as many times as possible within 30 seconds. The number of full stands completed is recorded. This test assesses functional lower limb muscle strength and core stability. An increase in the number of repetitions indicates an improvement in functional strength.
Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacla Medical Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 9, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-PD-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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