Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHunan Normal University
About this 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:
* 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Powered Lower-Limb Exoskeleton
DeviceA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Older AdultsExperimental treatment 1 intervention
Group B: Young Adult Reference ParticipantsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
During each trial visit following completion of the assigned study condition (up to 5 days)2
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.
Time frame
During each trial visit following completion of the assigned study condition (up to 5 days)Secondary outcomes
1
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.
Time frame
During each trial visit following the assigned study condition, up to 5 days.2
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.
Time frame
During each trial visit following the assigned study condition, up to 5 days.3
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.
Time frame
Immediately after the 400-meter walk test during each trial visit, up to 5 days.4
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.
Time frame
After physical performance testing during each trial visit, up to 5 days.Other outcomes
1
Number of Falls
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.2
Number of Near-Loss-of-Balance Events
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.3
Number of Device-Related Adverse Events
Number of adverse events judged to be caused by, probably caused by, or associated with use of the powered lower-limb exoskeleton.
Time frame
From enrollment through completion of the final study visit, up to 5 days.Sponsors and contacts
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Source ClinicalTrials.gov