Parkinson's Disease (PD)NCT07384364
Observational Study Evaluating Robotic Spinal Mobilization in 16 Parkinson's Disease Participants. The Study Recorded Changes in Mobility, Sit-to-stand Performance, and Pain Scores After a 2-week Intervention With the BackHug Device.
An observational study of Parkinson's Disease (PD), run by Pacla Medical Limited at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease (PD)
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2025to 10 Dec 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Diagnosis: Confirmed clinical diagnosis of Parkinson's Disease.
- Disease Severity: Hoehn and Yahr Scale Stage 3 or below (indicating mild to moderate disability with preserved postural reflexes).
- Functional Mobility: Ability to walk independently for approximately 5 minutes. Use of walking poles is permitted; reliance on a walking frame (Zimmer frame) or wheelchair excludes participation.
- Consent: Willing and able to provide informed consent and attend all four scheduled therapy sessions.
Who cannot join
- Spinal \& Bone Pathology: Diagnosis of spinal malignancy (benign or malignant tumors), active spinal infection (e.g., tuberculosis), severe congenital defects (dysplasia), metabolic bone disease (e.g., severe osteomalacia), or currently healing spinal fractures/dislocations.
- Inflammatory Conditions: Severe Rheumatoid Arthritis or other inflammatory arthritides causing potential spinal instability.
- Neurological Contraindications (Non-PD): Evidence of spinal cord compression, spinal cord damage, or Cauda Equina syndrome.
- Vascular \& Hematological Risks: History of aortic dysfunction (e.g., abdominal aortic aneurysm, blood clot), severe haemophilia, or unmanaged bleeding disorders.
- Other: Current pregnancy; History of active cancer (excluding localized squamous cell carcinoma); Recent spinal surgery.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Manual Therapy Clinic
Edinburgh, Scotland, EH12 5EH
About this study
Official title: A Prospective, Single-Arm, Observational Case Series Evaluation of the Impact of Robotic Spinal Mobilization on Functional Mobility, Axial Rigidity, Chronic Back Pain, and Sleep Quality in Community-Dwelling Adults With Parkinson's Disease
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.
Read the detailed description
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:
- Administrator Qualifications: All functional assessments were administered by HCPC-registered physiotherapists trained in standard PD assessment protocols (e.g., TUG, STS) to ensure inter-rater reliability.
- Source Data Verification: Primary functional data was recorded on standardized paper Assessment Forms (source documents) at the point of care. These were subsequently verified against the electronic study database.
- Video Verification: Where participant consent was granted, video recordings of functional tests were utilized as source data to cross-verify the accuracy of timed metrics (e.g., confirming gait speed to the nearest millisecond).
- Data Consistency Checks: The data management system employed logic checks during entry to flag out-of-range values (e.g., age outside 18-75, VAS scores outside 0-10) for immediate review against clinician notes.
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.
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson Disease, Axial Rigidity, Robotic Spinal Mobilization, Functional Mobility, Pain, Sleep quality
- Medical subject headings
- Parkinson Disease, Pain, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (prior to first intervention) and Post-Intervention (Session 4, approximately 2 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start24 Sep 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacla Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384364
- Sponsor's protocol ID
- PM-PD-2025-01
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Observational Case Series Evaluation of the Impact of Robotic Spinal Mobilization on Functional Mobility, Axial Rigidity, Chronic Back Pain, and Sleep Quality in Community-Dwelling Adults With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07384364
- Acronym / sponsor ID
- PM-PD-2025-01
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson Disease, Axial Rigidity, Robotic Spinal Mobilization, Functional Mobility, Pain, Sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pacla Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Administrator Qualifications: All functional assessments were administered by HCPC-registered physiotherapists trained in standard PD assessment protocols (e.g., TUG, STS) to ensure inter-rater reliability.
- Source Data Verification: Primary functional data was recorded on standardized paper Assessment Forms (source documents) at the point of care. These were subsequently verified against the electronic study database.
- Video Verification: Where participant consent was granted, video recordings of functional tests were utilized as source data to cross-verify the accuracy of timed metrics (e.g., confirming gait speed to the nearest millisecond).
- Data Consistency Checks: The data management system employed logic checks during entry to flag out-of-range values (e.g., age outside 18-75, VAS scores outside 0-10) for immediate review against clinician notes.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- Diagnosis: Confirmed clinical diagnosis of Parkinson's Disease.
- Disease Severity: Hoehn and Yahr Scale Stage 3 or below (indicating mild to moderate disability with preserved postural reflexes).
- Functional Mobility: Ability to walk independently for approximately 5 minutes. Use of walking poles is permitted; reliance on a walking frame (Zimmer frame) or wheelchair excludes participation.
- Consent: Willing and able to provide informed consent and attend all four scheduled therapy sessions.
Key exclusion criteria (5 listed)
- Spinal \& Bone Pathology: Diagnosis of spinal malignancy (benign or malignant tumors), active spinal infection (e.g., tuberculosis), severe congenital defects (dysplasia), metabolic bone disease (e.g., severe osteomalacia), or currently healing spinal fractures/dislocations.
- Inflammatory Conditions: Severe Rheumatoid Arthritis or other inflammatory arthritides causing potential spinal instability.
- Neurological Contraindications (Non-PD): Evidence of spinal cord compression, spinal cord damage, or Cauda Equina syndrome.
- Vascular \& Hematological Risks: History of aortic dysfunction (e.g., abdominal aortic aneurysm, blood clot), severe haemophilia, or unmanaged bleeding disorders.
- Other: Current pregnancy; History of active cancer (excluding localized squamous cell carcinoma); Recent spinal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Change in Functional Mobility (3-Meter Timed Up and Go Test)
Time frame: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).
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.
3 secondary outcomes
Percent Change in Subjective Back Pain Intensity (Visual Analog Scale) From Baseline
Time frame: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).
Percent Change in Self-Reported Sleep Quality From Baseline
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)
Time frame: Baseline (prior to first intervention) and Post-Intervention (Session 4, approximately 2 weeks post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD), run by Pacla Medical Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Functional Mobility (3-Meter Timed Up and Go Test) (time frame: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.