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

NCT07633093 | Not Yet Recruiting

• 1 other identifier: HNU-2026-408
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aging; Walking; Mobility Limitation; Physical Function

Keywords

Exoskeleton; Wearable Robotics; Gait Speed; Assistive Technology; Mobility Assistance

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During each trial visit following completion of the assigned study condition (up to 5 days)

Secondary Outcomes (7)

• Short Physical Performance Battery Score

  During each trial visit following the assigned study condition, up to 5 days.

• Mean Heart Rate During the 400-Meter Walk

  During each trial visit following the assigned study condition, up to 5 days.

• Borg Rating of Perceived Exertion

  Immediately after the 400-meter walk test during each trial visit, up to 5 days.

• Fear of Falling 10-Rating Scale Score

  After physical performance testing during each trial visit, up to 5 days.

• Activities-specific Balance Confidence Scale Score

  After physical performance testing during each trial visit, up to 5 days.

Other Outcomes (3)

• Number of Falls

  From enrollment through completion of the final study visit, up to 5 days.

• Number of Near-Loss-of-Balance Events

  From enrollment through completion of the final study visit, up to 5 days.

• Number of Device-Related Adverse Events

  From enrollment through completion of the final study visit, up to 5 days.

Study Arms (2)

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.

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.

Interventions

Powered Lower-Limb Exoskeleton DEVICE

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.

Older Adults

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Normal University: lead

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Zhang, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Zhang, PhD

CONTACT

727-251-9431; yzhang68@crimson.ua.edu

Bo Liu, MS

CONTACT

8613217485573; 202110150267@hunnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the visible nature of the powered lower-limb exoskeleton intervention, neither participants nor study personnel could be blinded to condition assignment. All assessments were therefore conducted under open-label conditions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Independent Scientific Advisor

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share