Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Older Adults

Sponsor
Hunan Normal University
Study ID
NCT07633093
Status
Recruiting
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Conditions

  • Aging
  • Mobility Limitation
  • Physical Function
  • Walking

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Powered Lower-Limb Exoskeleton — DEVICE
    A commercially available powered wearable lower-limb exoskeleton (VIATRIX; ULS Robotics Co., Ltd., Shanghai, China) designed to provide bilateral lower-limb assistance during walking. The device is worn around the pelvis and lower limbs and provides powered assistance through bilateral actuation. During powered-device assessments, participants use the adaptive assistive walking mode following device fitting and familiarization procedures.

Study Details

The goal of this clinical trial is to learn whether a powered wearable lower-limb exoskeleton can improve walking performance in independently ambulatory older adults aged 65 to 75 years. The main questions it aims to answer are: * Does use of a powered lower-limb exoskeleton increase comfortable walking speed over 10 meters? * Does use of a powered lower-limb exoskeleton increase average walking speed during a 400-meter walk? Researchers will compare walking performance in older adults during walking with the powered exoskeleton and walking without the device to determine whether the exoskeleton improves mobility. Young-adult reference participants will also complete walking assessments to provide reference values for walking performance. Participants will: * Attend a screening and familiarization visit. * Complete walking assessments with and without the powered exoskeleton in randomized order (older adults only). * Perform a 10-meter walk test, a 400-meter walk test, and other physical performance assessments. * Complete questionnaires about balance confidence, fear of falling, and device usability. * Be monitored for safety events during testing.

Key Dates

First listed
Jun 8, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Older Adults
    Community-dwelling older adults aged 65-75 years who complete walking assessments under both no-device and powered-exoskeleton conditions in randomized order using a crossover design. Participants attend a screening and familiarization visit followed by two trial visits.
  • No Intervention: Young Adult Reference Participants
    Healthy young adults aged 18-22 years who complete no-device walking assessments to provide reference values for walking performance. Participants are not randomized and do not receive the powered exoskeleton intervention.

Primary Outcome Measure

10-Meter Comfortable Gait Speed [ Time Frame: During each trial visit following completion of the assigned study condition (up to 5 days) ]

Central Contacts

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