Leg Dexterity Trainer for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new Leg Dexterity System designed to help individuals with knee osteoarthritis (OA) manage pain and improve function at home. The system employs a simple, safe device that trains leg control and stability, and it is compared to traditional wobble board exercises. Participants will use the device at home to determine if it reduces pain and improves movement more effectively than current methods. Suitable candidates for this trial include those diagnosed with knee osteoarthritis who experience moderate to severe knee pain.
As an unphased trial, this study provides participants the opportunity to explore innovative pain management solutions before they become widely available.
Do I need to stop taking my current medications for the trial?
The trial requires you to stop using opioid pain medications at least 8 weeks before joining and throughout the study. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.
What prior data suggests that the Leg Dexterity Trainer is safe for knee osteoarthritis patients?
Research shows that the Leg Dexterity Trainer is a safe option for people with knee osteoarthritis. Studies have found that this device is low-risk because it uses gentle movements and doesn't require standing or bearing full weight. This eliminates the risk of falling, as the exercises are performed while sitting.
Participants in earlier studies used the Leg Dexterity Trainer without major safety issues. The device is easy to use and includes technology that tracks progress. This system helps improve movement and reduce pain, making it a promising tool for managing knee osteoarthritis at home.
In summary, earlier trials have well-received the Leg Dexterity Trainer. The gentle, seated exercises make it a safe choice for improving knee function without the worry of falls or injuries.12345Why are researchers excited about this trial?
Most treatments for knee osteoarthritis focus on pain relief or inflammation reduction, such as NSAIDs or physical therapy. The Leg Dexterity Trainer is unique because it aims to enhance neuromuscular control by training the leg to manage unstable foot-ground interactions. This method is particularly exciting because it offers a proactive approach to improving joint function and stability, rather than just addressing symptoms. By using a specialized device and a tablet-based app for guidance, it provides a novel way to potentially improve mobility and quality of life for those with knee osteoarthritis.
What evidence suggests that the Leg Dexterity Trainer is effective for knee osteoarthritis?
Research has shown that exercises to improve proprioception, the body's ability to sense joint movement, can reduce pain and enhance life quality for people with knee osteoarthritis (OA). In this trial, participants will use the Leg Dexterity Trainer, which aims to improve control over leg movements, crucial for managing knee OA. Studies have found that exercises like strength training can enhance physical function and reduce pain in knee OA. The Leg Dexterity Trainer focuses on improving leg control and alleviating knee OA symptoms. Early findings suggest that enhancing proprioception and muscle control may aid in managing knee OA. Another group in this trial will use a Wobble Board, a well-known intervention for knee OA, to compare its effectiveness with the Leg Dexterity Trainer.14678
Who Is on the Research Team?
Scott Tashman, PhD
Principal Investigator
Steadman Philippon Research Institute
Are You a Good Fit for This Trial?
This trial is for adults aged 60 or older with knee osteoarthritis who are looking for non-surgical ways to manage their condition. Participants should be able to perform exercises at home and have access to a tablet computer. They must not have conditions that would interfere with the study or pose additional risks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment and Training
Participants undergo baseline assessment and training on the use of either the Leg Dexterity system or the wobbleboard
Treatment
Participants perform home-based training using their assigned device (Leg Dexterity or wobbleboard) 3 times per week for 8 weeks
Follow-up
Participants return for follow-up assessment, repeating baseline assessments and returning the equipment
What Are the Treatments Tested in This Trial?
Interventions
- Leg Dexterity Trainer
Trial Overview
The trial tests a new Leg Dexterity System against traditional wobble board exercises, both done at home. The goal is to see if the new system can better reduce pain and improve function in people with knee OA over an 8-week period, using feedback from a connected tablet.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Steadman Philippon Research Institute
Lead Sponsor
Neuromuscular Dynamics
Collaborator
National Institute on Aging (NIA)
Collaborator
Citations
Home-Based Leg Dexterity Trainer for Management of ...
Study: The investigators will conduct a randomized home-based clinical trial in knee OA to demonstrate the efficacy of leg dexterity training ...
Proprioceptive Training and Outcomes of Patients With Knee ...
PrT, ST, PrT + ST program were effective in improving symptoms and quality of life among individuals with knee OA; no differences between groups in WOMAC survey ...
Impact of strength training on physical function, ...
Conclusions. Short-term strength training effectively reduces pain and enhances function in knee OA patients. Both low- and high-load exercises ...
systematic review and network meta-analysis
Main outcome measures Primary outcomes included pain, function, gait performance, and quality of life, assessed at short term (four weeks), mid- ...
Effect of high-intensity training on improving knee flexion ...
This study found that high-intensity training can significantly improve knee flexion strength and leg press strength, and improve KOOS symptoms ...
SPRI and Neuromuscular Dynamics Launch NIH-Funded ...
Eight-week study evaluates the “Leg Dexterity System,” a novel at-home device designed to improve mobility and reduce pain through ...
The Effect of Balance Training on Functional Outcomes ... - PMC
The findings of studies showed that physical function in knee OA patients could have clinical improvements significantly after receiving balance training.
Effect of high-intensity training on improving knee flexion ...
High-intensity exercise significantly improves knee flexion strength, leg press strength, and KOOS symptoms and QoL in knee osteoarthritis patients.
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