Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Change in Functional Mobility (Gait Speed and Agility) [Time frame: Baseline and 4 weeks.]

Secondary outcome measures (3)

• Change in Subjective Back Pain Intensity [Time frame: Baseline and 4 weeks.]
• Change in Self-Reported Sleep Quality [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07376122 · PM-PD-2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗