An interventional study of Wearable Ankle Power Training (WearAPT) and Control in Sedentary Behavior / Physical Inactivity and Aged, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
375 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.
This study's planned enrollment of 72 is close to the median of 70 across 322 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,370 studies on the registry; 133 are open to participants now.
Of its 160 completed or terminated interventional studies of FDA-regulated products, 139 (87%) have results posted.
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Exclusion Criteria:
Wearable ankle power training via resistive exoskeleton with push-off biofeedback
Other: Wearable Ankle Power Training (WearAPT)
Dose and intensity matched treadmill walking alone
Other: Control
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.
Also known as: Resistive ankle exoskeleton
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).
Habitual Walking Speed (m/s)
Average preferred walking speed during a 10-meter walk
Time frame: Baseline, Week 7, Week 19
6-min Walk Test Distance (m)
Maximum distance walked in 6 minutes
Time frame: Baseline, Week 7, Week 19
Walking Stride Length (m)
Average stride length during walking at habitual speed
Time frame: Baseline, Week 7, Week 19
Calf Muscle Size (cm)
Average plantarflexor cross-sectional area will be computed using ultrasound
Time frame: Baseline, Week 7, Week 19
Calf muscle strength (N/kg)
Maximum strength of the plantarflexor muscles measured using a dynamometer
Time frame: 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)
Time frame: Baseline, Week 7, Week 19
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.
Time frame: Baseline, Week 7, Week 19
Walking Economy (W/kg)
Net metabolic power estimated via expired gases during walking
Time frame: Baseline, Week 7, Week 19
Muscle coordination
The investigators will compute changes in the relative weighting of activation of the major plantarflexor muscles compared to more proximal leg muscles.
Time frame: Baseline, Week 7, Week 19
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2030, 38 months later.
Of 250 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 38 months is above that.
Counting every sponsor, half of 253 studies reached it within 22 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill →