Parkinson's Disease (PD)NCT07376122
Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease
A study testing BackHug Robotic Spinal Mobilization System in people with Parkinson's Disease (PD), run by Pacla Medical Limited.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- BackHug Robotic Spinal Mobilization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- BackHug Robotic Spinal Mobilization System
- Keywords
- Axial Rigidity, Spinal Mobilization, Robotic Therapy, Chronic Pain, Sleep Quality, Gait Disorders
- Medical subject headings
- Parkinson Disease, Chronic Pain, Sleep Initiation and Maintenance Disorders, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BackHug Robotic Spinal Mobilization SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: BackHug Robotic Therapy | Experimental | Not described Receives: Device: BackHug Robotic Spinal Mobilization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Mobility (Gait Speed and Agility)
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.
Measured: Baseline and 4 weeks.
Secondary outcomes (3)
Change in Subjective Back Pain Intensity
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.
Measured: Baseline and 4 weeks.
Change in Self-Reported Sleep Quality
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.
Measured: Baseline and 4 weeks.
Change in Functional Lower Limb Strength (30-Second Sit-to-Stand Test)'
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.
Measured: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start9 Mar 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacla Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376122
- Sponsor's protocol ID
- PM-PD-2026-01
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 37068206Yang 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.
PubMed 27004637Van 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.
PubMed 10025495
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07376122
- Acronym / sponsor ID
- PM-PD-2026-01
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Axial Rigidity, Spinal Mobilization, Robotic Therapy, Chronic Pain, Sleep Quality, Gait Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pacla Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: BackHug Robotic Therapy | Experimental | Device: BackHug Robotic Spinal Mobilization System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BackHug Robotic Spinal Mobilization SystemParticipants 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. | Device | Experimental: BackHug Robotic Therapy |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Results publication: PubMed 37068206Seckinogullari 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.
- Results publication: PubMed 27004637Yang 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.
- Results publication: PubMed 10025495Van 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.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing BackHug Robotic Spinal Mobilization System in people with Parkinson's Disease (PD), run by Pacla Medical Limited.
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: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chongsu Lee, MSc, MCSP, BEng (+447905771727, chongsu@paclamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Mobility (Gait Speed and Agility) (time frame: Baseline and 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376122, which also lists 3 linked publications.
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 30 Jan 2026.