Home-based leg dexterity training for knee osteoarthritis

Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis

This study will test whether an at-home leg dexterity device can reduce pain and improve function for people aged 40–85 with knee osteoarthritis compared with wobble-board exercises.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Steadman Philippon Research Institute (Academic / other)
• Locations: 1 site (Vail, Colorado)
• Trial ID: NCT07397806 on ClinicalTrials.gov

What this trial studies

Researchers will randomize 84 ambulatory adults with radiographic knee osteoarthritis (Kellgren-Lawrence grade II–IV) to 8 weeks of home-based leg dexterity training using a slender unstable spring system (42 participants) or to dose-matched wobble board exercises (42 participants), with longitudinal follow-up at the Steadman Philippon Research Institute. The trial is designed as a double-blind, dose-matched comparison focused on neuromuscular control and whole-body function. Primary outcomes are the WOMAC Pain subscale and the Single Limb Stance Test, while secondary outcomes include WOMAC stiffness and physical function subscales and the IKDC subjective score. The aim is to see if targeted proprioceptive and short-latency sensorimotor retraining produces greater pain relief and functional gains than commonly prescribed wobble-board exercises.

Who should consider this trial

Good fit: Ambulatory adults aged 40–85 with Kellgren-Lawrence grade II–IV knee osteoarthritis, baseline target-knee pain of 3–10 on an 11-point scale, and the capacity to give informed consent are ideal candidates.

Not a fit: Patients who recently had or plan knee surgery, are non-ambulatory, or have medical conditions preventing safe use of home exercise devices are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the device could provide a safe at-home supplement that reduces knee pain and improves leg function, potentially delaying or reducing the need for surgical interventions.

How similar studies have performed: Proprioceptive and balance exercises such as wobble-board training have shown benefit in knee OA, but the specific leg dexterity spring device is novel and has not been widely tested in randomized trials.

Eligibility criteria

INCLUSION CRITERIA:

1. Age 40 to 85 years
2. Ambulatory in home and community settings
3. History of knee osteoarthritis in one or both knees (Kellgren-Lawrence grade II-IV)
4. 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).
5. 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

EXCLUSION CRITERIA:

1. Previous or Planned Knee Surgeries, Procedures, and/or Treatments:

   1. Planned surgery on either the contralateral or target knee at any time during the Study period, including pre-and post-training assessments.
   2. 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;
   3. Within 12 weeks of signing informed consent has received intra-articular treatment of the target knee with steroids or hyaluronic acid derivatives;
   4. 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.
   5. 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
2. Current and/or Previous Medical Conditions, Surgeries, and/or Procedures:

   1. 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).
   2. Current diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria.
   3. 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.
   4. 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.
   5. 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.
3. 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.

Where this trial is running

Vail, Colorado

• Steadman Philippon Research Institute — Vail, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Scott Tashman, PhD — Steadman Philippon Research Institute
• Study coordinator: Sara Robinson, MS

Conditions Osteo Arthritis of the Knee; osteoarthritis; knee; exercise; dexterity