Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Pain: Numerical Rating Scale
研究概览
简要总结
Rationale:
Roughly 14 million adults aged 60 or older (10% male/13% female) in the United States experience symptoms of knee osteoarthritis (OA). Knee OA pain progressively impacts aging, reducing mobility and increasing morbidity. Nonsurgical self-management of knee OA includes exercise to promote proper knee mechanics, non-steroidal anti-inflammatory drugs (NSAIDs), cortisone injections, and weight loss to reduce pain and retain function. As OA has no cure, self-management progresses to ~1 million joint replacements per year. Critically, home-based devices are lacking for specifically training the low-level proprioceptive and neuromuscular circuitry for proper knee mechanics in a safe, focused, mechanistic way. Such devices would supplement exercises for strength, mobility, and whole-body loading and movement.
Initially considered a wear-and-tear condition, knee OA is now understood as a complex disease involving inflammatory responses to mechanical loading and neuromuscular feedback loops among pain, joint damage, and dynamic loading. Home-based exercises remain a primary nonpharmacological and nonsurgical approach to managing chronic pain in OA that fundamentally disrupts proprioception and neuromuscular control of the joint, which accelerates articular degeneration.
Neuromuscular Dynamics, LLC has developed a simple, safe, quick, and effective Leg Dexterity System that is portable, wireless, and coupled to HIPAA-compliant cloud analytics. A seated participant uses their foot to compress a platform atop a slender spring, which becomes unstable as it begins to buckle at low forces. The participant must then control their leg dexterity (i.e., via short-latency sensorimotor circuits) to stabilize the unstable dynamic foot-ground interactions. A tablet computer connected to the device provides feedback during use and uploads the participant's activity data to the server for analysis and reporting, accessible to users and clinicians.
The investigators have successfully tested Leg Dexterity in control participants in multiple publications. The Leg Dexterity test is safe and poses minimal risk as the forces needed to do it are very low, does not involve full weight- bearing maneuvers, and is performed while seated without the risk of falling.
Study:
The investigators will conduct a randomized home-based clinical trial in knee OA to demonstrate the efficacy of leg dexterity training to reduce pain and improve function compared to currently prescribed dynamic exercise on a wobble board (a commonly used approach for improving proprioception and balance). Successful completion of this study will justify the adoption of the Leg Dexterity System as an effective at-home supplement to any nonsurgical management of knee OA.
The investigators propose a longitudinal double-blind dose-matched trial comparing 8 weeks of leg dexterity training (Treatment using a slender, unstable spring system that engages short-latency sensorimotor control, 42 participants) vs. at-home wobble board exercises (Control, 42 participants) at the Steadman Philippon Research Institute.
详细描述
The investigators will conduct a randomized home-based clinical trial in knee OA to demonstrate the efficacy of leg dexterity training to reduce pain and improve function compared to currently prescribed dynamic exercise on a wobble board (a commonly used approach for improving proprioception and balance). Successful completion of this study will justify the adoption of the Leg Dexterity System as an effective at-home supplement to any nonsurgical management of knee OA.
The investigators propose a longitudinal double-blind dose-matched trial comparing 8 weeks of leg dexterity training (Treatment using a slender, unstable spring system that engages short-latency sensorimotor control, 42 participants) vs. at-home wobble board exercises (Control, 42 participants) at the Steadman Philippon Research Institute.
Primary Hypothesis: Neuromuscular control: Compared to the Control group, the Treatment group will report greater reduction in knee pain and demonstrate improved function in the more-affected leg. The primary outcomes measures will include The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain subscale and the Single Limb Stance Test (SLS).
Secondary Hypothesis: Whole-body function: Compared to the Control group, greater OA-related whole-body functional improvements will be found in the Treatment group. Secondary outcome measures include the WOMAC stiffness and physical function subscales; International Knee Documentation Committee (IKDC) Subjective Knee score, Timed-up-and-go test (TUG); 6 min walk test (6MW); 40-meter walk (40mW) Test; and lower-extremity Gait analysis.
The Leg Dexterity System:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 85 years
- •Ambulatory in home and community settings
- •History of knee osteoarthritis in one or both knees (Kellgren-Lawrence grade II-IV)
- •Baseline pain of 3-10 points on the target (i.e., more-affected) knee and a pain differential of at least -2 points on the contralateral knee as exhibited by the worst pain score for the previous week (on the 11-point Numeric Rating Scale, NRS/Visual Analog Scale VAS).
- •Capacity to personally give informed consent (consent via a legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments
排除标准
- •Previous or Planned Knee Surgeries, Procedures, and/or Treatments:
- •Planned surgery on either the contralateral or target knee at any time during the Study period, including pre-and post-training assessments.
- •Within 6 months of signing informed consent has received diagnostic arthroscopy of the target knee or arthroscopic surgery (including microfracture and meniscectomy) on the target knee;
- •Within 12 weeks of signing informed consent has received intra-articular treatment of the target knee with steroids or hyaluronic acid derivatives;
- •Planned intra-articular treatment of the target knee with steroids or hyaluronic acid derivatives on either the contralateral or target knee at any time during the Study period including pre-and post-training assessments.
- •History of previous total or partial arthroplasty in the target knee. Partial or total arthroplasty in the contralateral knee is acceptable as long as the surgery was performed at least 6 months prior to enrollment and the operative knee is asymptomatic
- •Current and/or Previous Medical Conditions, Surgeries, and/or Procedures:
- •Within 2 years of signing informed consent, history of active blood disorders (i.e., DVTs, chronic blood clotting, hemophilia, leukemia, myeloma, etc.); or active malignancy of any type or history of a malignancy (with the exception of subjects with a history of treated basal or squamous cell carcinoma).
- •Current diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria.
- •Any active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism requiring hormone replacement only, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of systemic inflammatory arthritis such as psoriatic, rheumatoid, ankylosing spondylitis or reactive arthritis.
- •Current or prior history of other joint diseases including but not limited to joint dysplasia, crystal-induced arthropathy (such as gout, or calcium pyrophosphate deposition disease evidenced by clinical and/or radiographic means), aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler syndrome, joint infection, hemochromatosis, or neuropathic arthropathy of any cause.
- •Any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Investigator or his designee) constitutes a risk or contraindication for participation in the Study or that could interfere with the Study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the Study.
- •Within 8 weeks of signing informed consent, has used opioid analgesics and is not willing to discontinue these medications through the duration of the study.
研究组 & 干预措施
Leg Dexterity Training
For the Lex Dexterity Training group, participants will be seated at the edge of a standard-height (76 cm) table and instructed to hold on to the edge of the table and support their weight equally through the table and the support leg before placing the foot of the training leg on the device's platform. The training leg will be positioned in a standardized posture (85 - 95° of hip and knee flexion) with the foot on the platform. Participants will press down on the platform ten (10) times, one leg at a time. Subjects will be asked to reach and hold the maximal force they can sustain before the device becomes unstable, thus engaging and training their neuromuscular control of unstable foot-ground interactions. After the initial in-person training session, participants will take the device home, with instructions to complete the training protocol (approximately 10-minute sessions) 3 times per week. The sessions are guided and logged with a tablet-based app.
干预措施: Lex Dexterity Trainer (Device)
Wobble Board
The Wobble Board (Control) group will train for 10 minute sessions 3 times per week on a commercially available wobble board, with a safety rail system to provide support and prevent falls. The wobbleboard is a well-known, safe and moderately effective intervention for treating knee OA. This training will consist of 5 repetitions each of: (i) forward/backward and (ii) side-to-side board tilts, and 30 seconds of (iv) single-leg stance on each leg. As previously described, this wobbleboard protocol is a safe and effective intervention in knee OA. As shown, the wobble board is equipped with safety bars to protect against falls. After the initial in-person training session, participants will take the wobble board and safety rails home, with instructions to complete the training protocol (approximately 10-minute sessions) 3 times per week. The sessions are guided and logged with a tablet-based app.
干预措施: Wobble Board (Device)
结局指标
主要结局
Pain: Numerical Rating Scale
时间窗: Pain will be assessed during the baseline visit and after the 8-week training session.
Study participants will complete the 11-point Numerical Rating Scale (NRS), which is a simple and frequently used pain assessment tool across both clinical research and clinical practice. The resulting score is a unitless integer ranging from 0 to 10, with 0 being no pain and 10 being the most pain imaginable.
Pain and Function: WOMAC
时间窗: Womac will be assessed during the baseline visit and after the 8-week training session.
Study participants will complete the Western Ontario McMaster Osteoarthritis Index (WOMAC) pain subscale, which consists of 5 questions about pain experienced during activities like walking, using stairs, and standing. Each item is rated on a 5-point Likert scale from 0 to 4: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme. Scores from each subsale are summed to produce a unitless pain/function score.
次要结局
- Single Leg Stance Test: stance time(Baseline and after completion of the 8-week training session)
- Performance-Based Physical Function(Baseline and after completion of the 8-week training session)
- Gait Analysis(Baseline and after completion of the 8-week training session)
- o 12-Item Short Form Health Survey (SF-12)(Baseline and after the 8-week training intervention)
- Single Leg Stance (SLS) test: Center of Mass Displacement(Baseline and after completion of the 8-week training session)
研究者
Scott Tashman
Director, Biomedical Engineering
Steadman Philippon Research Institute