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NCT07633093
Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Older Adults
Conditions: Aging, Walking, Physical Function, Mobility Limitation
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Hunan Normal University
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.
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
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.
Source: ClinicalTrials.gov (NCT07633093). StuddyBuddy aggregates publicly available trial information.