Early Phase 1
N=9
Ankle Assistance and Resistance in Older Adults
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT06284525 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in 6MWT — 48.3 m
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Ankle resistance and biofeedback (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Northern Arizona University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 6MWT |
48.3 | — |
| PRIMARY Change in Metabolic Power |
-0.09 | — |
| PRIMARY Change in Plantar Flexor Force Production |
0.6 | — |
Summary
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
Inclusion Criteria
- Age between 65 and 85 years old, inclusive.
- Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
- Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
- The ability to read and understand English.
- Able to walk at least 30 feet with or without a walking aid
- Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
Exclusion Criteria
- Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time. Note: For elderly participants, a history of joint replacement or joint degeneration that does not impair their ability to walk safely is allowable.
- Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
Data sourced from ClinicalTrials.gov (NCT06284525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.