Taking people in United StatesNo phase

Home leg training device for people with knee osteoarthritis

Tests a home leg dexterity trainer in people with knee osteoarthritis.

Key facts

Who runs it: Steadman Philippon Research Institute
Where: Vail, United StatesSee the site
Trial code: NCT07397806
Registry title: Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis
Status: Recruiting
People taking part: 82 people, planned
Started: 11 Sept 2025
Expected to end: 31 Dec 2027
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Lex Dexterity Trainer
Wobble Board
Record updated: 9 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with knee osteoarthritis (wear and inflammation of the knee joint) who can walk at home and in the community. It compares home leg dexterity training with wobble board exercises.

Age: 40 to 85 years
Sex: All sexes
Disease stage: Knee osteoarthritis in one or both knees, Kellgren-Lawrence grade II-IV (moderate to severe on X-ray). Worst pain last week of 3-10 points in the more-affected knee, at least 2 points more than in the other knee.
Earlier treatment: No arthroscopy or arthroscopic surgery on the target knee within 6 months. No steroid or hyaluronic acid injection into the target knee within 12 weeks. No partial or total knee replacement in the target knee. People who used opioid painkillers within 8 weeks must be willing to stop them for the whole study.

Main reasons for not taking part

Knee surgery or knee injections planned during the study
Blood disorders, such as clots or hemophilia, or cancer within 2 years (treated basal or squamous cell skin cancer is allowed)
Fibromyalgia, or an active systemic autoimmune disease or inflammatory arthritis such as rheumatoid or psoriatic arthritis
Other joint diseases, such as gout, joint infection or osteonecrosis
Not able to give consent personally

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

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

Who cannot take part

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
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
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 40 and 85 years old?

Where in United States

Steadman Philippon Research InstituteVail, United StatesContact: Sara Robinson, MSTaking people

About the trial

What the trial wants to find out

Rationale:

Read full original descriptionShow less

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.

The 2 groups in the trial

Leg Dexterity TrainingTreatment being tested
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.
Treatment: Lex Dexterity Trainer
Wobble BoardExisting treatment, for comparison
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.