Ankle Assistance and Resistance in Older Adults

NCT06284525 | Completed Early Phase 1 Results FDA Device

• 1 other identifier: 2137420
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (3)

• Change in 6MWT

  Change (post - baseline) in six minute walk test distance (distance in meters)

  Baseline assessment and 1-week post training assessment (at 5 weeks)

• Change in Metabolic Power

  Change (post - baseline) in metabolic power measured in J/(kgm)

  Baseline assessment and 1-week post training assessment (at 5 weeks)

• Change in Plantar Flexor Force Production

  Change (post - baseline) in manual muscle testing plantar flexor force production measured in N/kg

  Baseline assessment and 1-week post training assessment (at 5 weeks)

Study Arms (1)

Gait training with exoskeleton resistance

EXPERIMENTAL

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.

Device: Ankle resistance and biofeedback

Interventions

Ankle resistance and biofeedback DEVICE

An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.

Gait training with exoskeleton resistance

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Arizona University: lead

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: Principal investigator
• Organization: Northern Arizona University

Zachary.Lerner@nau.edu

928-523-1787

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 29, 2024
• Study Start: February 1, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)