Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease

Pacla Medical Limited

Status

Begins enrollment this month

Conditions

Parkinson's Disease (PD)

Treatments

Device: BackHug Robotic Spinal Mobilization System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07376122

PM-PD-2026-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.