An observational study in Parkinson's Disease (PD), sponsored by Pacla Medical Limited. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Pacla Medical Limited · Observational
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.
Study Rationale and Background: Axial rigidity is a cardinal motor feature of Parkinson's Disease (PD) that contributes significantly to gait impairment, balance dysfunction, and chronic pain. Unlike appendicular symptoms, axial symptoms often show limited response to standard dopaminergic medication. This study investigated 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.
Technical Description of the Intervention: The BackHug device is an automated spinal mobilization system featuring 26 independent robotic therapeutic heads. The mechanism employs real-time load sensing to adapt pressure to the user's spinal curvature. Participants received a standardized 40-minute protocol targeting the neck, shoulders, thoracic, and lumbar spine. Treatment intensity was personalized to user tolerance via the device's control app.
Quality Assurance and Data Validation Plan: To ensure data integrity and minimize bias in this observational setting, the following quality assurance procedures were implemented:
Data Management and Missing Data
Data Dictionary: All variables were defined according to standard clinical scales (e.g., Visual Analog Scale 0-10 cm; Likert Scale 1-5).
Handling of Missing Data: The study adhered to a Per-Protocol analysis. Missing data points resulting from missed sessions or incomplete assessments were documented in the study log but excluded from the final efficacy calculation for that specific endpoint. No data imputation methods were used.
Statistical Analysis Plan
Sample Size Assessment: As a pilot observational case series, the sample size (N=16) was determined based on feasibility and the capacity of the single-center clinical facility. The objective was to generate effect size estimates and standard deviation data sufficient to power a future randomized controlled trial (RCT).
Descriptive Statistics: Baseline demographics (Age, Gender, Disease Duration) were summarized using means and standard deviations.
Efficacy Analysis: The primary analytical method compared Pre-Intervention vs. Post-Intervention scores to determine the percentage change in performance. Paired t-tests were employed to assess the statistical significance of acute and longitudinal changes in functional mobility and strength.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 19 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Pacla Medical Limited is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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
Exclusion Criteria:
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.
Time frame: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).
Percent Change in Subjective Back Pain Intensity (Visual Analog Scale) From Baseline
Participants self-report their current level of back pain intensity using a Visual Analog Scale (VAS) ranging from 0 to 10. 0 = No Pain 10 = Worst Possible Pain A decrease in the score indicates a reduction in pain intensity.
Time frame: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).
Percent Change in Self-Reported Sleep Quality From Baseline
Participants rate their overall sleep quality using a numerical rating scale from 0 to 5. 0 = Very Poor Sleep 5 = Excellent Sleep An increase in the score indicates an improvement in sleep quality and restoration.
Time frame: 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)
Participants are instructed to sit in a chair 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. Results are reported as a percent change from baseline. A positive value indicates an increase in the number of repetitions completed, representing an improvement in functional strength.
Time frame: Baseline (prior to first intervention) and Post-Intervention (Session 4, approximately 2 weeks post-baseline)
Recruitment was conducted at a single site in Edinburgh, UK. Participants were identified through social media advertising (Meta/Facebook, LinkedIn) and word-of-mouth referrals. Recruitment activities were targeted specifically at community-dwelling individuals in the Edinburgh area. The active recruitment period ran from September 15, 2025, to November 24, 2025.
| Milestone | Single Intervention Arm |
|---|---|
| Started | 19 |
| Completed | 16 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
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.
| percentage of change | Single Intervention Arm |
|---|---|
| Percent Change in Functional Mobility (3-Meter Timed Up and Go Test) | -23.02 ± 10.73 |
Participants self-report their current level of back pain intensity using a Visual Analog Scale (VAS) ranging from 0 to 10. 0 = No Pain 10 = Worst Possible Pain A decrease in the score indicates a reduction in pain intensity.
| percentage of change | Single Intervention Arm |
|---|---|
| Percent Change in Subjective Back Pain Intensity (Visual Analog Scale) From Baseline | -66.8 ± 28.4 |
Participants rate their overall sleep quality using a numerical rating scale from 0 to 5. 0 = Very Poor Sleep 5 = Excellent Sleep An increase in the score indicates an improvement in sleep quality and restoration.
| percentage of change | Single Intervention Arm |
|---|---|
| Percent Change in Self-Reported Sleep Quality From Baseline | -34.1 ± 25.2 |
Participants are instructed to sit in a chair 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. Results are reported as a percent change from baseline. A positive value indicates an increase in the number of repetitions completed, representing an improvement in functional strength.
| percentage of change | Single Intervention Arm |
|---|---|
| Percent Change in Functional Lower Limb Strength (30-Second Sit-to-Stand Test) | 60.85 ± 59.09 |
Collected over Adverse events were collected from the time of signed informed consent until the final study visit (approximately 2 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Intervention Arm | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) |
| Event | Single Intervention Arm |
|---|---|
| Transient muscle sorenessMusculoskeletal and connective tissue disorders | 1/19 |
Baseline characteristics are presented for the 16 participants who completed the study protocol. 3 participants withdrew prior to study completion and are excluded from this analysis.
| Age, Continuous(Years) | Single Intervention Arm |
|---|---|
| Mean | 59.3 ± 10.5 |
| Sex: Female, Male(Participants) | Single Intervention Arm |
|---|---|
| Female | 3 |
| Male | 13 |
| Race and Ethnicity Not Collected(Participants) | Single Intervention Arm |
|---|
| Duration of Parkinson's Disease(Years) | Single Intervention Arm |
|---|---|
| Mean | 3.6 ± 3.7 |
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Pacla Medical Limited