Ankle Devices for Sarcopenia

Overseen By Zach Lerner, PhD

Age: 65+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northern Arizona University

Disqualifiers: Neurological, Musculoskeletal, Cardiorespiratory, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new ankle devices to help older adults improve their walking ability. Researchers aim to determine if ankle resistance training and wearable devices can enhance mobility. Participants will use an exoskeleton for ankle resistance and biofeedback while walking on a treadmill. This trial suits individuals aged 65 to 85 who can walk at least 30 feet, with or without a walking aid, and do not have conditions that make walking difficult. As an Early Phase 1 trial, this research focuses on understanding how these innovative devices function in people, offering participants a chance to be among the first to experience this new technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ankle device is safe for improving mobility in older individuals?

Research shows that ankle exoskeletons used for resistance training can improve mobility. A previous study demonstrated that different types of ankle exoskeletons enhanced walking ability. However, detailed safety information specifically about ankle resistance and biofeedback remains unavailable.

As this trial begins, direct evidence about safety in humans is limited. Early trials often assess how well participants tolerate a new treatment. In this study, participants will wear devices during short training sessions to identify any potential issues.

Resistance training generally improves muscle function in older adults, and these wearable devices aim to assist without causing harm. Participants might experience temporary discomfort as their muscles adapt to the new activity, but serious side effects are unlikely based on existing knowledge of resistance training.

Overall, while this study's wearable device is still under evaluation, early research suggests it could safely help older adults improve their walking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ankle resistance and biofeedback treatment for sarcopenia because it introduces a novel approach to muscle strengthening. Unlike traditional treatments that often rely on medications or generalized exercise programs, this technique uses a unique combination of exoskeleton-assisted gait training and real-time biofeedback. This innovative method specifically targets the ankle muscles during the stance phase of walking, potentially enhancing muscle strength and coordination more effectively. By focusing on these specific muscle groups with tailored resistance, this treatment could offer a more efficient and personalized way to combat sarcopenia-related muscle loss.

What evidence suggests that ankle resistance and biofeedback is effective for improving mobility in older individuals with sarcopenia?

Research shows that ankle resistance and biofeedback, which participants in this trial will receive, can greatly improve walking in older adults. One study found that biofeedback adjusted ankle strength by about 14% to 17%, aiding walking. Exercise, including resistance training, improves physical performance and muscle strength in people with sarcopenia, a condition that leads to muscle loss. Other research confirms that resistance training increases muscle strength and size, which is important for better movement. These findings suggest that ankle resistance and biofeedback might effectively help older adults walk better. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for older adults with sarcopenia, which means they've lost muscle mass and strength. Participants should be interested in improving their walking ability. Specific eligibility details are not provided, so generally healthy older adults looking to enhance mobility may apply.

Inclusion Criteria

The ability to read and understand English

Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used

Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination

Exclusion Criteria

Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise

I can walk safely without being hindered by any health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Gait Training

Participants complete 20-30 minutes of ankle resistance training on each visit, involving walking on a treadmill with stance phase ankle resistance and biofeedback.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ankle Resistance and Biofeedback

Trial Overview The study is testing two approaches: one where participants walk with added resistance at the ankle to strengthen muscles, and another where they use wearable devices that assist movement at the ankle, knee, or hip to improve walking.

How Is the Trial Designed?

Group I: Gait training with exoskeleton resistance Experimental Treatment 1 Intervention

Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

Citations

1. mdpi.com mdpi.com/1424-8220/24/7/2230

A State-of-the-Art of Exoskeletons in Line with the WHO's ... The findings revealed substantial positive outcomes across diverse health conditions. LLE training led to improvements in key performance ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7897464/

Ankle Power Biofeedback Reverses the Distal-to-Proximal ... Results: Biofeedback systematically elicited changes in ankle power; increasing and decreasing ankle power by 14% and 17% when targeting ±20% ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40349627/

Effectiveness of different types of exercise based- ... This meta-analysis supported the use of physical exercise to improve the physical performance and muscular strength of people with sarcopenia.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0531556521000954

The influence of resistance training on neuromuscular ... Resistance training (RT) improves muscle strength and mass. However, the effects of RT on neuromuscular adaptations in middle-aged and older adults are unclear.

5. researchgate.net researchgate.net/publication/390992568_Effects_of_Resistance_Training_on_Sarcopenia_Risk_Among_Healthy_Older_Adults_A_Scoping_Review_of_Physiological_Mechanisms

(PDF) Effects of Resistance Training on Sarcopenia Risk ... This scoping review aims to consolidate studies that have explored RT programs in mitigating sarcopenia among healthy older adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11014060/

A State-of-the-Art of Exoskeletons in Line with the WHO's ... Fang (2022) [33] evaluated two protocols involving assistance and resistance modes of an ankle exoskeleton and reported an improvement in ...

7. nature.com nature.com/articles/s41598-025-10429-9

Lower extremity muscle activation patterns in sarcopenic ... Physical performance assessment has become an integral part of sarcopenia diagnosis, severity evaluation, and adverse outcomes prediction.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jcsm.13576

Sarcopenia interventions in long‐term care facilities ... This study aimed to identify, appraise and synthesize the interventions targeting sedentary behaviour and physical inactivity, construct a Theory of Change ...