Ankle Assistance and Resistance in Older Adults

Sarcopenia Clinical Trial

Official title:

Ankle Assistance and Resistance in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284525
• Other study ID #: 2137420
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Northern Arizona University
• Contact: Zach Lerner, PhD
• Phone: 928-523-1787
• Email: Zachary.Lerner[@]nau.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The overarching goal of this study is to improve mobility in older adults through advances in wearable assistance (i.e. powered orthoses). This goal will be accomplished by focusing on two specific research 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.

Several powered orthosis conditions will be tested during several modes of walking or running and balance throughout the course of the study. Trials will take place over-ground and/or on a treadmill. Balance trials will take place on a treadmill. Participants will walk for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue; a maximum of 15 minutes of continuous walking will take place between breaks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Northern Arizona University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6MWT	Six minute walk test distance (distance in meters)	1 day
Primary	Metabolic power	Metabolic power measured in Watts/kg	1 day
Primary	Plantar flexor strength	Manual muscle testing plantar flexor strength measured in N	1 day