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Recruiting NCT07633093

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

No phase Interventional Aging Walking Physical Function Mobility Limitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Powered Lower-Limb Exoskeleton.
Who it may be relevant to
Registry conditions: Aging, Walking, Physical Function, Mobility Limitation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Acute Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Community-Dwelling Older Adults: A Randomized Crossover Trial

Overview

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.

Detailed description

Age-related decline in mobility is associated with reduced independence, lower quality of life, and increased risk of disability and adverse health outcomes. Walking performance is a clinically meaningful indicator of functional status in older adults, and preservation of mobility is a major goal of healthy aging. Although exercise and rehabilitation interventions can improve mobility, their benefits typically require repeated training and sustained adherence. Technologies that provide immediate assistance during walking may offer a complementary approach to supporting mobility in older adults.

Powered wearable lower-limb exoskeletons are designed to provide external mechanical assistance during locomotion. Previous studies have shown that lower-limb exoskeletons can reduce the metabolic cost of walking and improve walking performance under laboratory conditions. However, less is known about the acute effects of commercially available exoskeleton systems on clinically relevant walking outcomes in independently ambulatory older adults.

This study will evaluate the acute effects of a commercially available powered lower-limb exoskeleton on walking performance in community-dwelling older adults. The primary outcomes are comfortable gait speed during a 10-meter walk test and average walking speed during a 400-meter walk test. Secondary outcomes include lower-extremity physical performance, physiological responses during walking, perceived exertion, balance confidence, fear of falling, device usability, participant satisfaction, and safety outcomes.

The study uses a randomized crossover design. Older adult participants will complete two experimental conditions in randomized order: walking without the exoskeleton and walking with the powered exoskeleton. Participants will attend a screening and familiarization visit followed by two trial visits separated by at least 48 hours. During the familiarization visit, participants will receive device fitting and supervised practice with the exoskeleton. At each trial visit, participants will complete standardized walking and physical performance assessments under the assigned condition.

A young-adult reference group will complete no-device walking assessments to provide reference values for walking performance. Exploratory analyses will examine whether exoskeleton-assisted walking reduces the performance gap between older adults and young adults.

The study hypothesis is that use of the powered exoskeleton will improve both short-distance and sustained walking performance in older adults and partially reduce the mobility performance gap between older and young adults.

Interventions

  • Device Powered Lower-Limb Exoskeleton
    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.

Primary outcome measures

  • 10-Meter Comfortable Gait Speed [Time frame: During each trial visit following completion of the assigned study condition (up to 5 days)]
  • 400-Meter Average Walking Speed [Time frame: During each trial visit following completion of the assigned study condition (up to 5 days)]
Secondary outcome measures (7)
  • Short Physical Performance Battery Score [Time frame: During each trial visit following the assigned study condition, up to 5 days.]
  • Mean Heart Rate During the 400-Meter Walk [Time frame: During each trial visit following the assigned study condition, up to 5 days.]
  • Borg Rating of Perceived Exertion [Time frame: Immediately after the 400-meter walk test during each trial visit, up to 5 days.]
  • Fear of Falling 10-Rating Scale Score [Time frame: After physical performance testing during each trial visit, up to 5 days.]
  • Activities-specific Balance Confidence Scale Score [Time frame: After physical performance testing during each trial visit, up to 5 days.]
  • System Usability Scale Score [Time frame: After completion of the powered-device trial visit, up to 5 days.]
  • Quebec User Evaluation of Satisfaction With Assistive Technology 2.0 Device Subscale Score [Time frame: After completion of the powered-device trial visit, up to 5 days.]

Eligibility criteria

Inclusion criteria

  • Older adults aged 65 to 75 years who are community-dwelling, independently ambulatory, able to walk independently on level ground, able to maintain standing balance without personal assistance, and able to understand study instructions.
  • Young-adult reference participants aged 18 to 22 years who are healthy university students without known conditions affecting walking or balance.

Exclusion criteria

  • Self-reported neurological disease affecting gait or balance.
  • Major musculoskeletal injury or surgery affecting walking within the previous 6 months.
  • Uncontrolled cardiopulmonary disease.
  • Severe visual or vestibular impairment affecting safe walking.
  • Current lower-limb pain that limits walking.
  • Cognitive impairment that prevents informed consent or protocol adherence.
  • Any condition judged by the study team to make participation unsafe.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • Hunan Normal University — Changsha

Identifiers

NCT: NCT07633093 · HNU-2026-408

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗