Sedentary Behavior / Physical InactivityNCT07897461
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
A study testing Wearable Ankle Power Training (WearAPT) in people with Sedentary Behavior / Physical Inactivity and Aged, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
This project introduces and investigates the scientific premise that passive wearable therapeutic devices can enhance plantarflexor muscle performance during walking to elicit and promote lasting physiological and functional improvements for older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sedentary Behavior / Physical Inactivity, Aged
- What is being tested?
- Wearable Ankle Power Training (WearAPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2027to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- insufficient weekly physical activity levels (i.e., ≤150 minutes moderate-intensity or ≤75 minutes vigorous-intensity activity)
- self-select a habitual walking speed deemed indicative of age-related slowing (i.e., ≤1.1 m/s)
- self-report at least some physical ability limitations (i.e., ≥4 on the "Stay Independent" questionnaire).
Who cannot join
- leg injury or fracture within the last 6 months
- diagnosed anemia
- neurological disorder of the legs such as peripheral neuropathy
- vascular disorder of the legs such as peripheral arterial disease
- taking medication that causes dizziness
- cannot walk without an assistive aid (i.e., cane or walker)
- Mini Mental State Exam ≤25
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Applied Biomechanics Laboratory
Chapel Hill, North Carolina, 27599
Jason R Franz, PhD, 919-966-6119, jrfranz@email.unc.edu
Biomechatronics Laboratory
Flagstaff, Arizona, 86011
Zachary Lerner, PhD, 928-523-1787, Zachary.Lerner@nau.edu
About this study
This project introduces and investigates the scientific premise that passive wearable therapeutic devices can enhance plantarflexor muscle performance during walking to elicit and promote lasting physiological and functional improvements for older adults. The investigators aim to quantify the preliminary efficacy of wearable plantarflexor resistance training to enhance gait performance in older adults, investigate neural and muscular mechanisms of adaptation, and identify target candidate characteristics for personalized treatment strategies. The investigators will test the hypothesis that, compared to baseline and unlike controls, WearAPT will increase peak ankle power output, stride length, habitual and maximum walking speeds, walking economy, and 6-min walk distance.
Read the detailed description
This proposal will address the critical need for novel and evidence-based therapeutics to enhance muscle function, mobility, and independence to those in our rapidly aging population. Walking disability in older adults is characterized by shorter steps, slower habitual walking speeds, and higher metabolic energy costs. These functional impairments stem from precipitous reductions in ankle (plantarflexor) push-off power output that cannot be improved by conventional strength training. Motivated by the need to overcome the poor compliance and functional transfer of traditional interventions and the extraordinary cost of powered exosuits, the investigators contend that smart passive devices providing targeted ankle resistance have the potential to revolutionize wearable therapeutics for context-specific adaptation of the plantarflexor muscles during walking to elicit and promote lasting physical and functional improvements for older adults. The investigators will complete a multi-site, blinded, pilot randomized controlled trial (RCT) to quantify the efficacy of a 6-week Wearable Ankle Power Training (WearAPT) intervention with push-off biofeedback to enhance gait performance in older adults while: (i) gaining muscular and neural insight into mechanisms of adaptation and (ii) identifying target candidate characteristics toward the development of personalized treatment strategies.
The investigators will recruit n=36 slow walking (≤1.1 m/s) and inactive older adults with self-reported physical ability limitations at each of two sites, randomly assigned to WearAPT (20 min twice weekly for a total of 12 training sessions) or a control group participating in intensity-matched treadmill walking alone. A mixed factorial analysis (group assignment, time) will examine differences both pre- and post-intervention and at a +3-month follow-up visit.
- Conditions
- Sedentary Behavior / Physical Inactivity, Aged
- Being tested
- Wearable Ankle Power Training (WearAPT), Control
- Keywords
- Exoskeleton, Gait, Ankle, Assistive Technologies, Plantarflexor, Inactive older adults, Slow-walking older adults
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Ankle Power Training (WearAPT)Other
Also called Resistive ankle exoskeleton
Participants will complete two supervised, 20-min WearAPT sessions per week over the 6-week intervention period. Informed by a pilot study and designed to ensure a standardized starting point for all participants, all subjects will initially begin their first visit walking at their baseline preferred (self-selected) treadmill walking speed, and with 0 Nm of ankle resistive torque. The investigators will increase the resistance by 0.025 Nm/kg per minute, up to a maximum of 0.15 Nm/kg on the first session. On subsequent sessions, walking speed and resistance will be increased based on two evidence-based criteria monitored in 5-min intervals: (i) rate of perceived exertion (RPE) between 4 and 6, and (ii) a target heart rate indicative of moderate intensity activity (i.e., 50-70% maximum heart rate). The investigators will increase walking speed by 2.5% per session and resistive torque by 0.025 Nm/kg per week.
ControlOther
Participants randomly assigned to the control group will participate in pre- and post- laboratory visits and will complete a protocol of dose- (i.e., 20 min) and intensity-matched (i.e., heart rate) unresisted treadmill walking alone. Specifically, control participants will walk at a speed designed to elicit the same target within-session heart rate (i.e., 50-70% maximum).
| Study group | Role | What they receive |
|---|---|---|
| WearAPT | Experimental | Wearable ankle power training via resistive exoskeleton with push-off biofeedback Receives: Other: Wearable Ankle Power Training (WearAPT) |
| Control | Active comparator | Dose and intensity matched treadmill walking alone Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habitual Walking Speed (m/s)
Average preferred walking speed during a 10-meter walk
Measured: Baseline, Week 7, Week 19
6-min Walk Test Distance (m)
Maximum distance walked in 6 minutes
Measured: Baseline, Week 7, Week 19
Walking Stride Length (m)
Average stride length during walking at habitual speed
Measured: Baseline, Week 7, Week 19
Calf Muscle Size (cm)
Average plantarflexor cross-sectional area will be computed using ultrasound
Measured: Baseline, Week 7, Week 19
Calf muscle strength (N/kg)
Maximum strength of the plantarflexor muscles measured using a dynamometer
Measured: Baseline, Week 7, Week 19
Calf muscle excitation
The magnitude of habitual plantar flexor muscle activation during walking will be computed using recording electrodes (i.e., electromyography)
Measured: Baseline, Week 7, Week 19
Secondary outcomes (1)
Peak ankle power output (W/kg)
Quantitative motion capture and inverse dynamics will compute the peak net ankle power output extracted from the push-off phase of walking.
Measured: Baseline, Week 7, Week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary Behavior / Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jason Franz, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897461
- Sponsor's protocol ID
- 26-2756
- Other IDs
- 1R01AG090334-01A1
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
- ClinicalTrials.gov ID
- NCT07897461
- Acronym / sponsor ID
- 26-2756
- Conditions
- Sedentary Behavior / Physical Inactivity, Aged
- Keywords
- Exoskeleton, Gait, Ankle, Assistive Technologies, Plantarflexor, Inactive older adults, Slow-walking older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project introduces and investigates the scientific premise that passive wearable therapeutic devices can enhance plantarflexor muscle performance during walking to elicit and promote lasting physiological and functional improvements for older adults. The investigators aim to quantify the preliminary efficacy of wearable plantarflexor resistance training to enhance gait performance in older adults, investigate neural and muscular mechanisms of adaptation, and identify target candidate characteristics for personalized treatment strategies. The investigators will test the hypothesis that, compared to baseline and unlike controls, WearAPT will increase peak ankle power output, stride length, habitual and maximum walking speeds, walking economy, and 6-min walk distance.
Detailed description
This proposal will address the critical need for novel and evidence-based therapeutics to enhance muscle function, mobility, and independence to those in our rapidly aging population. Walking disability in older adults is characterized by shorter steps, slower habitual walking speeds, and higher metabolic energy costs. These functional impairments stem from precipitous reductions in ankle (plantarflexor) push-off power output that cannot be improved by conventional strength training. Motivated by the need to overcome the poor compliance and functional transfer of traditional interventions and the extraordinary cost of powered exosuits, the investigators contend that smart passive devices providing targeted ankle resistance have the potential to revolutionize wearable therapeutics for context-specific adaptation of the plantarflexor muscles during walking to elicit and promote lasting physical and functional improvements for older adults. The investigators will complete a multi-site, blinded, pilot randomized controlled trial (RCT) to quantify the efficacy of a 6-week Wearable Ankle Power Training (WearAPT) intervention with push-off biofeedback to enhance gait performance in older adults while: (i) gaining muscular and neural insight into mechanisms of adaptation and (ii) identifying target candidate characteristics toward the development of personalized treatment strategies.
The investigators will recruit n=36 slow walking (≤1.1 m/s) and inactive older adults with self-reported physical ability limitations at each of two sites, randomly assigned to WearAPT (20 min twice weekly for a total of 12 training sessions) or a control group participating in intensity-matched treadmill walking alone. A mixed factorial analysis (group assignment, time) will examine differences both pre- and post-intervention and at a +3-month follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WearAPT | Experimental | Other: Wearable Ankle Power Training (WearAPT)Wearable ankle power training via resistive exoskeleton with push-off biofeedback |
| Control | Active comparator | Other: ControlDose and intensity matched treadmill walking alone |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- insufficient weekly physical activity levels (i.e., ≤150 minutes moderate-intensity or ≤75 minutes vigorous-intensity activity)
- self-select a habitual walking speed deemed indicative of age-related slowing (i.e., ≤1.1 m/s)
- self-report at least some physical ability limitations (i.e., ≥4 on the "Stay Independent" questionnaire).
Key exclusion criteria (7 listed)
- leg injury or fracture within the last 6 months
- diagnosed anemia
- neurological disorder of the legs such as peripheral neuropathy
- vascular disorder of the legs such as peripheral arterial disease
- taking medication that causes dizziness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Ankle Power Training (WearAPT)Also: Resistive ankle exoskeletonParticipants will complete two supervised, 20-min WearAPT sessions per week over the 6-week intervention period. Informed by a pilot study and designed to ensure a standardized starting point for all participants, all subjects will initially begin their first visit walking at their baseline preferred (self-selected) treadmill walking speed, and with 0 Nm of ankle resistive torque. The investigators will increase the resistance by 0.025 Nm/kg per minute, up to a maximum of 0.15 Nm/kg on the first session. On subsequent sessions, walking speed and resistance will be increased based on two evidence-based criteria monitored in 5-min intervals: (i) rate of perceived exertion (RPE) between 4 and 6, and (ii) a target heart rate indicative of moderate intensity activity (i.e., 50-70% maximum heart rate). The investigators will increase walking speed by 2.5% per session and resistive torque by 0.025 Nm/kg per week. | Other | WearAPT |
| ControlParticipants randomly assigned to the control group will participate in pre- and post- laboratory visits and will complete a protocol of dose- (i.e., 20 min) and intensity-matched (i.e., heart rate) unresisted treadmill walking alone. Specifically, control participants will walk at a speed designed to elicit the same target within-session heart rate (i.e., 50-70% maximum). | Other | Control |
Primary outcome
Habitual Walking Speed (m/s)
Time frame: Baseline, Week 7, Week 19
Average preferred walking speed during a 10-meter walk
6-min Walk Test Distance (m)
Time frame: Baseline, Week 7, Week 19
Maximum distance walked in 6 minutes
Walking Stride Length (m)
Time frame: Baseline, Week 7, Week 19
Average stride length during walking at habitual speed
Calf Muscle Size (cm)
Time frame: Baseline, Week 7, Week 19
Average plantarflexor cross-sectional area will be computed using ultrasound
Calf muscle strength (N/kg)
Time frame: Baseline, Week 7, Week 19
Maximum strength of the plantarflexor muscles measured using a dynamometer
Calf muscle excitation
Time frame: Baseline, Week 7, Week 19
The magnitude of habitual plantar flexor muscle activation during walking will be computed using recording electrodes (i.e., electromyography)
1 secondary outcome
Peak ankle power output (W/kg)
Time frame: Baseline, Week 7, Week 19
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Franz, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Ankle Power Training (WearAPT) in people with Sedentary Behavior / Physical Inactivity and Aged, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason R Franz, PhD (919-966-6119, jrfranz@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Habitual Walking Speed (m/s) (time frame: Baseline, Week 7, Week 19). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.