A Prospective, Single-Arm Pilot Study Evaluating the Effect of Robotic Spinal Mobilization (BackHug) on Mobility, Pain, and Sleep in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Functional Mobility (Gait Speed and Agility)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: BackHug Robotic Therapy
干预措施: BackHug Robotic Spinal Mobilization System (Device)
结局指标
主要结局
Change in Functional Mobility (Gait Speed and Agility)
时间窗: 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.
次要结局
- Change in Subjective Back Pain Intensity(Baseline and 4 weeks.)
- Change in Self-Reported Sleep Quality(Baseline and 4 weeks.)
- Change in Functional Lower Limb Strength (30-Second Sit-to-Stand Test)'(Baseline (Session 1) and Post-Intervention (Session 4, approximately 2 weeks later))