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

8 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+