Osteo Arthritis of the KneeNCT07397806
Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis
A study testing Lex Dexterity Trainer and Wobble Board in people with Osteo Arthritis of the Knee, run by Steadman Philippon Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- Lex Dexterity Trainer and Wobble Board
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Steadman Philippon Research Institute
Vail, Colorado, 81657
Sara Robinson, MS, 970-401-8717, srobinson@sprivail.org
Scott Tashman, PhD, 970-238-8094, tashman@me.com
About this study
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.
Read more
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.
Read the detailed description
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:
To use the Leg Dexterity system, seated individuals are instructed to use a single leg to slowly compress the spring with the platform with the goal to make the force feedback line as high as possible (i.e., maximize vertical compression force) throughout each ~10 second trial without letting the foot slip on the platform (see Figure). The spring begins to show instabilities at low forces. Participants are informed that it is ok for the spring to bend and oscillate (i.e., due to the instability inherent in task). Despite the motion, the goal is to maintain the highest possible force level without the spring buckling (which occurs when the force exceeds 15% of body weight). Because the spring becomes increasingly instable even at these low forces, the maximal sustained compression quantifies their maximal neuromuscular control abilities.
The Wobble Board:
Commercial wobble boards (Core-Tex Reactive Trainer, Core-Tex Fitness, Inc. shown at right). are an intervention used at home and the clinic to improve leg and body dynamic control. As shown, the wobble board is equipped with safety bars to protect against falls and poses minimal risk for older adults and adults with knee OA. To use the wobble board with eyes open, participants will stand on the center of the board and perform 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. This wobbleboard protocol is a safe and effective intervention in knee OA[67,68], and participants are encouraged to minimize the use of the handle bars within their comfort level to maximize and improve leg and body dynamic control.
Participant Assignment:
After informed consent, study participants will undergo a baseline assessment and be randomized to receive either the Leg Dexterity device or the wobbleboard. They will then take their assigned device home, with instructions to perform the exercises they were trained on 3 times per week for 8 weeks and maintain a log of their activities. After 8 weeks, they will return to the Steadman Philippon Research Institute for a repeat assessment and to return the equipment.
Establish the clinical feasibility, utility and efficacy of using a home-based Leg Dexterity training program to reduce pain and improve function for individuals with osteoarthritis.
There is a single endpoint at 8 weeks after initiation of training.
- 82 patient participants with knee osteoarthritis, targeting equal numbers of male and female participants.
This is a Phase II clinical trial, providing an initial assessment of efficacy.
Single-center study conducted at the Steadman Philippon Research Institute in Vail, CO
Participants will be randomized into one of two home treatment regimens, utilizing either the Leg Dexterity system or a commercially available wobbleboard. Training will occur 3 times per week for 8 weeks.
36 months
The initial visit will consist of informed consent, screening, baseline testing and training on the proper use of either the Knee Dexterity system or the wobbleboard. This visit will take approximately 3 hours. Participants will then conduct 8 weeks of home-based training using their assigned device. They will then return for their follow-up visit, during which the assessments performed at baseline will be repeated. This visit will take approximately 90 minutes. The supplied training device will be returned and study participation will be complete. Total study duration for each participant will be approximately 10 weeks.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- Lex Dexterity Trainer, Wobble Board
- Keywords
- osteoarthritis, knee, exercise, dexterity
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lex Dexterity TrainerDevice
The Leg Dexterity Trainer is a portable, wireless device. 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.
Wobble BoardDevice
A wobble board is a circular or rectangular board with a rounded base, designed to improve balance, core strength, and coordination by creating an unstable surface that challenges stability.
| Study group | Role | What they receive |
|---|---|---|
| Leg Dexterity Training | Experimental | 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. Receives: Device: Lex Dexterity Trainer |
| Wobble Board | Active comparator | 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. Receives: Device: Wobble Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: Numerical Rating Scale
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.
Measured: Pain will be assessed during the baseline visit and after the 8-week training session.
Pain and Function: WOMAC
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.
Measured: Womac will be assessed during the baseline visit and after the 8-week training session.
Secondary outcomes (5)
Single Leg Stance Test: stance time
During the SLS, participants will be asked to maintain balance on each leg with their arms folded across their chest and eyes closed for at most 30 seconds on both stable (rigid surface) and unstable (e.g., 10 cm thick foam) surfaces on top of two Bertec® force plates with standardized software for SLS (Bertec, Inc., Columbus, OH). Participants will stand on the force plate and lift one foot off the floor (flexing the knee to approximately 60º) at their own pace and balance for up to 30 seconds. Trials will be terminated early upon ground contact with the non-test limb. Participants will complete three repetitions in each condition with each leg (12 total trials, 30 minutes for both legs). The first SLS outcome measure will be stance time.
Measured: Baseline and after completion of the 8-week training session
Performance-Based Physical Function
Measures of functional performance will include the 6-minute walk test (6MW), timed-up-and-go test (TUG), and 4-meter walk (4mW) tests. The 6MW test measures the distance walked in 6 minutes to evaluate endurance. The TUG measures the time it takes a patient to rise from an armchair (seat height of 46 cm), walk 3 m, turn, and return to sitting in the same chair without physical assistance. The 4mW will be assessed at the fastest safe speed for each participant and assess the capacity for performance of certain activities (e.g., crossing a street before the light changes). These tests have been established as meaningful outcome measures in older persons with a wide range of conditions and have demonstrated validity and reliability.
Measured: Baseline and after completion of the 8-week training session
Gait Analysis
Gait kinematics will be assessed using an 8-camera markerless motion capture system (Dari/Captury) during open-ground, free-speed walking. Three walking trials will be collected, with a minimum of 3 gait cycles per trial. Primary outcomes will be knee flexion angle (min/max/range and side-to-side symmetry) and stride parameters.
Measured: Baseline and after completion of the 8-week training session
o 12-Item Short Form Health Survey (SF-12)
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life.
Measured: Baseline and after the 8-week training intervention
Single Leg Stance (SLS) test: Center of Mass Displacement
During the SLS, participants will be asked to maintain balance on each leg with their arms folded across their chest and eyes closed for at most 30 seconds on both stable (rigid surface) and unstable (e.g., 10 cm thick foam) surfaces on top of two Bertec® force plates with standardized software for SLS (Bertec, Inc., Columbus, OH). Participants will stand on the force plate and lift one foot off the floor (flexing the knee to approximately 60º) at their own pace and balance for up to 30 seconds. Trials will be terminated early upon ground contact with the non-test limb. Participants will complete three repetitions in each condition with each leg (12 total trials, 30 minutes for both legs). The second SLS outcome measure will be the mean and maximum displacement of the Center of Pressure (COP) location in mm.
Measured: Baseline and after completion of the 8-week training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start11 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steadman Philippon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Neuromuscular Dynamics, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Scott Tashman, Steadman Philippon Research Institute
- Investigators
- Scott Tashman, PhD, Principal investigator, Steadman Philippon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397806
- Sponsor's protocol ID
- NMD-OA-2024
- Other IDs
- R44AG090114
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the reported results, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07397806
- Acronym / sponsor ID
- NMD-OA-2024
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- osteoarthritis, knee, exercise, dexterity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Steadman Philippon Research InstituteUniversity, hospital or other
- Collaborators
- Neuromuscular Dynamics, National Institute on Aging (NIA)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
To use the Leg Dexterity system, seated individuals are instructed to use a single leg to slowly compress the spring with the platform with the goal to make the force feedback line as high as possible (i.e., maximize vertical compression force) throughout each ~10 second trial without letting the foot slip on the platform (see Figure). The spring begins to show instabilities at low forces. Participants are informed that it is ok for the spring to bend and oscillate (i.e., due to the instability inherent in task). Despite the motion, the goal is to maintain the highest possible force level without the spring buckling (which occurs when the force exceeds 15% of body weight). Because the spring becomes increasingly instable even at these low forces, the maximal sustained compression quantifies their maximal neuromuscular control abilities.
The Wobble Board:
Commercial wobble boards (Core-Tex Reactive Trainer, Core-Tex Fitness, Inc. shown at right). are an intervention used at home and the clinic to improve leg and body dynamic control. As shown, the wobble board is equipped with safety bars to protect against falls and poses minimal risk for older adults and adults with knee OA. To use the wobble board with eyes open, participants will stand on the center of the board and perform 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. This wobbleboard protocol is a safe and effective intervention in knee OA[67,68], and participants are encouraged to minimize the use of the handle bars within their comfort level to maximize and improve leg and body dynamic control.
Participant Assignment:
After informed consent, study participants will undergo a baseline assessment and be randomized to receive either the Leg Dexterity device or the wobbleboard. They will then take their assigned device home, with instructions to perform the exercises they were trained on 3 times per week for 8 weeks and maintain a log of their activities. After 8 weeks, they will return to the Steadman Philippon Research Institute for a repeat assessment and to return the equipment.
Establish the clinical feasibility, utility and efficacy of using a home-based Leg Dexterity training program to reduce pain and improve function for individuals with osteoarthritis.
There is a single endpoint at 8 weeks after initiation of training.
- 82 patient participants with knee osteoarthritis, targeting equal numbers of male and female participants.
This is a Phase II clinical trial, providing an initial assessment of efficacy.
Single-center study conducted at the Steadman Philippon Research Institute in Vail, CO
Participants will be randomized into one of two home treatment regimens, utilizing either the Leg Dexterity system or a commercially available wobbleboard. Training will occur 3 times per week for 8 weeks.
36 months
The initial visit will consist of informed consent, screening, baseline testing and training on the proper use of either the Knee Dexterity system or the wobbleboard. This visit will take approximately 3 hours. Participants will then conduct 8 weeks of home-based training using their assigned device. They will then return for their follow-up visit, during which the assessments performed at baseline will be repeated. This visit will take approximately 90 minutes. The supplied training device will be returned and study participation will be complete. Total study duration for each participant will be approximately 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leg Dexterity Training | Experimental | Device: Lex Dexterity TrainerFor 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. |
| Wobble Board | Active comparator | Device: Wobble BoardThe 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Previous or Planned Knee Surgeries, Procedures, and/or Treatments:
- Current and/or Previous Medical Conditions, Surgeries, and/or Procedures:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lex Dexterity TrainerThe Leg Dexterity Trainer is a portable, wireless device. 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. | Device | Leg Dexterity Training |
| Wobble BoardA wobble board is a circular or rectangular board with a rounded base, designed to improve balance, core strength, and coordination by creating an unstable surface that challenges stability. | Device | Wobble Board |
Primary outcome
Pain: Numerical Rating Scale
Time frame: 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
Time frame: 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.
5 secondary outcomes
Single Leg Stance Test: stance time
Time frame: Baseline and after completion of the 8-week training session
Performance-Based Physical Function
Time frame: Baseline and after completion of the 8-week training session
Gait Analysis
Time frame: Baseline and after completion of the 8-week training session
o 12-Item Short Form Health Survey (SF-12)
Time frame: Baseline and after the 8-week training intervention
Single Leg Stance (SLS) test: Center of Mass Displacement
Time frame: Baseline and after completion of the 8-week training session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the reported results, after deidentification
Related trials for Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Tashman, PhD principal investigator
Steadman Philippon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lex Dexterity Trainer and Wobble Board in people with Osteo Arthritis of the Knee, run by Steadman Philippon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Robinson, MS (970-401-8717, srobinson@sprivail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: Numerical Rating Scale (time frame: Pain will be assessed during the baseline visit and after the 8-week training session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.