Hunan Normal University
Changsha, 81000, China
Location status: Recruiting
NCT Number: NCT07633093
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Changsha, 81000, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During each trial visit following completion of the assigned study condition (up to 5 days)
Comfortable gait speed (m/s) measured during a 10-meter walk test. Participants walk at their usual comfortable speed along a flat indoor walkway. Two trials are completed, and the mean gait speed is used for analysis.
Time frame: During each trial visit following completion of the assigned study condition (up to 5 days)
Average walking speed (m/s) measured during a 400-meter walk test. Participants walk 400 meters at a self-selected comfortable speed on an indoor walkway. Average walking speed is calculated as total walking distance divided by total completion time.
Time frame: During each trial visit following the assigned study condition, up to 5 days.
Lower-extremity physical performance assessed using the Short Physical Performance Battery. The test includes standing balance, short-distance gait speed, and repeated chair-stand performance. Component scores are summed to produce a total score ranging from 0 to 12, with higher scores indicating better physical performance.
Time frame: During each trial visit following the assigned study condition, up to 5 days.
Mean heart rate recorded continuously during the 400-meter walk test using a wrist-worn optical heart-rate monitor.
Time frame: Immediately after the 400-meter walk test during each trial visit, up to 5 days.
Perceived exertion is assessed immediately after the 400-meter walk test using the Borg Rating of Perceived Exertion Scale. Scores range from 6 to 20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion." Higher scores indicate greater perceived exertion and a worse outcome.
Time frame: After physical performance testing during each trial visit, up to 5 days.
Immediate fear of falling will be assessed after each trial condition using the single-item Fear of Falling 10-Point Rating Scale. Participants will rate how concerned they were about falling during the walking and physical performance tests completed during that visit. Scores range from 0 to 10, where 0 indicates "not concerned at all" and 10 indicates "extremely concerned." Higher scores indicate greater fear of falling and a worse outcome.
Time frame: After physical performance testing during each trial visit, up to 5 days.
Balance confidence will be assessed after each trial condition using the Activities-specific Balance Confidence Scale. The scale includes 16 activities, each rated from 0%, indicating no confidence in maintaining balance, to 100%, indicating complete confidence in maintaining balance. The total score is calculated as the mean of the 16 item scores and ranges from 0 to 100. Higher scores indicate greater balance confidence and a better outcome.
Time frame: After completion of the powered-device trial visit, up to 5 days.
Perceived usability of the powered lower-limb exoskeleton will be assessed after the powered-device condition using the 10-item System Usability Scale. Item responses are converted and summed to produce a total score ranging from 0 to 100. Higher scores indicate greater perceived usability of the exoskeleton and a better outcome.
Time frame: After completion of the powered-device trial visit, up to 5 days.
Participant satisfaction with the powered lower-limb exoskeleton will be assessed after the powered-device condition using the eight-item device subscale of the Quebec User Evaluation of Satisfaction With Assistive Technology 2.0. Each item is rated from 1, indicating "not satisfied at all," to 5, indicating "very satisfied." The device-subscale score is calculated as the mean of the valid device-item ratings and ranges from 1 to 5. Higher scores indicate greater satisfaction with the exoskeleton and a better outcome.
Time frame: From enrollment through completion of the final study visit, up to 5 days.
Number of falls occurring during study procedures. A fall is defined as an event in which the participant comes to rest inadvertently on the ground, floor, or another lower level.
Time frame: From enrollment through completion of the final study visit, up to 5 days.
Number of near-loss-of-balance events occurring during study procedures. A near-loss-of-balance event is defined as an observable unintended balance disturbance requiring a corrective response to prevent a fall.
Time frame: From enrollment through completion of the final study visit, up to 5 days.
Number of adverse events judged to be caused by, probably caused by, or associated with use of the powered lower-limb exoskeleton.
Contact information is provided by the study sponsor or research team.
Bo Liu, MS
CONTACT
Yang Zhang, PhD
CONTACT
Hunan Normal University
Other
Acute Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Community-Dwelling Older Adults: A Randomized Crossover Trial
Acronym: E-WALK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07513805
Aging, Fall Risk
Aurora, Colorado, United States
View Trial DetailsNCT07341061
Aging, Behavior
View Trial DetailsNCT07074613
Aging, Atrophy
Taipei, No. 177, Section 2, Neihu Rd., Taiwan
View Trial DetailsNCT06936865
Aging, Behavior
Madrid, Spain
View Trial Details