AgingE-WALKNCT07633093
Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Older Adults
A study testing Powered Lower-Limb Exoskeleton in people with Aging and Walking, run by Hunan Normal University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Walking, Physical Function
- What is being tested?
- Powered Lower-Limb Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 16 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Community-Dwelling Older Adults: A Randomized Crossover Trial
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:
Read more
- 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.
Read the 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.
- Conditions
- Aging, Walking, Physical Function, Mobility Limitation
- Being tested
- Powered Lower-Limb Exoskeleton
- Keywords
- Exoskeleton, Wearable Robotics, Gait Speed, Assistive Technology, Mobility Assistance
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Lower-Limb ExoskeletonDevice
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 group | Role | What they receive |
|---|---|---|
| Older Adults | Experimental | 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. Receives: Device: Powered Lower-Limb Exoskeleton |
| Young Adult Reference Participants | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Meter Comfortable Gait Speed
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.
Measured: During each trial visit following completion of the assigned study condition (up to 5 days)
400-Meter Average Walking Speed
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.
Measured: During each trial visit following completion of the assigned study condition (up to 5 days)
Secondary outcomes (7)
Short Physical Performance Battery Score
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.
Measured: During each trial visit following the assigned study condition, up to 5 days.
Mean Heart Rate During the 400-Meter Walk
Mean heart rate recorded continuously during the 400-meter walk test using a wrist-worn optical heart-rate monitor.
Measured: During each trial visit following the assigned study condition, up to 5 days.
Borg Rating of Perceived Exertion
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.
Measured: Immediately after the 400-meter walk test during each trial visit, up to 5 days.
Fear of Falling 10-Rating Scale Score
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.
Measured: After physical performance testing during each trial visit, up to 5 days.
Activities-specific Balance Confidence Scale Score
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.
Measured: After physical performance testing during each trial visit, up to 5 days.
System Usability Scale Score
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.
Measured: 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
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.
Measured: After completion of the powered-device trial visit, up to 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jul 2026
- Primary completion16 Aug 2026
- Study completion16 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Older adult participants complete two experimental conditions in randomized order across separate trial visits: walking without the powered exoskeleton and walking with the powered exoskeleton. Young-adult reference participants complete no-device walking assessments only and are not randomized to intervention conditions.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Zhang, Hunan Normal University
- Investigators
- Yang Zhang, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633093
- Sponsor's protocol ID
- HNU-2026-408
- Acronym
- E-WALK
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 18 Aug 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Community-Dwelling Older Adults: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07633093
- Acronym / sponsor ID
- E-WALK / HNU-2026-408
- Conditions
- Aging, Walking, Physical Function, Mobility Limitation
- Keywords
- Exoskeleton, Wearable Robotics, Gait Speed, Assistive Technology, Mobility Assistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 16 Aug 2026 (actual)
- Study completion
- 16 Aug 2026 (actual)
- First posted
- 8 Jun 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Older adult participants complete two experimental conditions in randomized order across separate trial visits: walking without the powered exoskeleton and walking with the powered exoskeleton. Young-adult reference participants complete no-device walking assessments only and are not randomized to intervention conditions.
| Arm | Type | Receives |
|---|---|---|
| Older Adults | Experimental | Device: Powered Lower-Limb ExoskeletonCommunity-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. |
| Young Adult Reference Participants | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Powered Lower-Limb ExoskeletonA 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. | Device | Older Adults |
Primary outcome
10-Meter Comfortable Gait Speed
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.
400-Meter Average Walking Speed
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.
7 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 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. This study is not recruiting at the moment.
Yang Zhang, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered Lower-Limb Exoskeleton in people with Aging and Walking, run by Hunan Normal University at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 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 18 Aug 2026.