Trial Outcomes & Findings for 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. (NCT NCT07384364)
NCT ID: NCT07384364
Last Updated: 2026-03-25
Results Overview
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.
COMPLETED
19 participants
Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).
2026-03-25
Participant Flow
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.
There was no washout or run-in period. All 19 enrolled participants met the eligibility criteria and were assigned directly to the single intervention arm to receive BackHug therapy.
Participant milestones
| Measure |
Single Intervention Arm
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the thoracic and lumbar spine to address axial rigidity.
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Single Intervention Arm
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the thoracic and lumbar spine to address axial rigidity.
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Intervention Arm
n=16 Participants
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the cervical, thoracic and lumbar spine, and the scapular joints, to address axial rigidity.
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Age, Continuous
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59.3 Years
STANDARD_DEVIATION 10.5 • n=16 Participants
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Sex: Female, Male
Female
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3 Participants
n=16 Participants
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Sex: Female, Male
Male
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13 Participants
n=16 Participants
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Duration of Parkinson's Disease
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3.6 Years
STANDARD_DEVIATION 3.7 • n=16 Participants
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PRIMARY outcome
Timeframe: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).Population: While 16 participants completed the overall study, the 3-meter TUG analysis is based on 13 participants. Three individuals were excluded from this specific analysis due to a ceiling effect, as their baseline TUG scores were 10 seconds or lower.
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.
Outcome measures
| Measure |
Single Intervention Arm
n=13 Participants
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the thoracic and lumbar spine to address axial rigidity.
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Percent Change in Functional Mobility (3-Meter Timed Up and Go Test)
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-23.02 percentage of change
Standard Deviation 10.73
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SECONDARY outcome
Timeframe: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).Population: Percentage change calculated as ((Post-Intervention Score - Baseline Score) / Baseline Score) \* 100. Negative values indicate a reduction (improvement) in pain intensity.
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.
Outcome measures
| Measure |
Single Intervention Arm
n=14 Participants
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the thoracic and lumbar spine to address axial rigidity.
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Percent Change in Subjective Back Pain Intensity (Visual Analog Scale) From Baseline
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-66.8 percentage of change
Standard Deviation 28.4
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SECONDARY outcome
Timeframe: Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later).Population: Data from participants with no sleep scores at baseline was excluded from this analysis. Percentage change calculated as ((Post - Pre) / Pre) \* 100. Negative values indicate improvement (reduction in sleep disturbance).
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.
Outcome measures
| Measure |
Single Intervention Arm
n=9 Participants
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the thoracic and lumbar spine to address axial rigidity.
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Percent Change in Self-Reported Sleep Quality From Baseline
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-34.1 percentage of change
Standard Deviation 25.2
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SECONDARY outcome
Timeframe: Baseline (prior to first intervention) and Post-Intervention (Session 4, approximately 2 weeks post-baseline)Population: Participants with a baseline score of 12 or greater (normal range) were excluded from analysis to avoid ceiling effects. Data reflects the 11 participants with baseline functional impairment.
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.
Outcome measures
| Measure |
Single Intervention Arm
n=11 Participants
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the thoracic and lumbar spine to address axial rigidity.
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Percent Change in Functional Lower Limb Strength (30-Second Sit-to-Stand Test)
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60.85 percentage of change
Standard Deviation 59.09
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Adverse Events
Single Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Intervention Arm
n=19 participants at risk
All participants in this single-arm study received the same intervention. Participants underwent a two-week therapy program consisting of four 40-minute robotic spinal mobilization sessions using the BackHug device. Sessions targeted the thoracic and lumbar spine to address axial rigidity.
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Musculoskeletal and connective tissue disorders
Transient muscle soreness
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5.3%
1/19 • Adverse events were collected from the time of signed informed consent until the final study visit (approximately 2 weeks).
Adverse events were monitored at each study visit. Participants were also instructed to report any adverse events immediately to the study team.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place