Usability of the Regen Gait Therapy Robot in Healthy Adults

NCT07547683 | Recruiting FDA Device

• 1 other identifier: STUDY00008251
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Regen is a robot-assisted device designed to help therapists and improve the quality of treatment. It works by replicating the movement of the therapist and providing assistance as needed for the patient. This study aims to assess the safety, feasibility, usability, and ability to Regen to replicate the movement pattern of therapist in young healthy adults during treadmill walking.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (4)

• System Usability Scale (SUS)

  The System Usability Scale (SUS) will be used to assess the usability of the device. The SUS consists of 10 items scored on a 5-point Likert scale and converted to a total score ranging from 0 to 100, with higher scores indicating better usability.

  During the experimental session (Day 1) and immediately post-task (within 10 minutes after completion)

• NASA Task Load Index (NASA-TLX)

  The NASA Task Load Index (NASA-TLX) will be used to assess perceived workload across six domains (mental demand, physical demand, temporal demand, performance, effort, and frustration). Scores range from 0 to 100, with higher scores indicating greater workload.

  During the experimental session (Day 1) and immediately post-task (within 10 minutes after completion)

• Device Acceptability (Likert Scale)

  Participants will rate safety, comfort, ease of use, and satisfaction using 5-point Likert scale items. Higher scores indicate greater acceptability of the device.

  Immediately post-task (within 10 minutes after completion, Day 1)

• Qualitative Feedback on Device Usability and Safety

  Open-ended questions will be used to collect qualitative feedback from participants and therapists regarding device usability, safety, and overall experience.

  Immediately post-task (within 10 minutes after completion, Day 1)

Study Arms (1)

Regen-assisted gait feasibility and usability arm

EXPERIMENTAL

Single experimental arm in which all participants complete treadmill walking under therapist-assisted and Regen-assisted conditions, to evaluate the feasibility and usability of the Regen robotic gait therapy system.

Device: Regen Rehabilitation Assistive Device

Interventions

Regen Rehabilitation Assistive Device DEVICE

Regen is a robotic gait therapy device that learns therapist-guided movement trajectories and autonomously reproduces them.

Regen-assisted gait feasibility and usability arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy study participants: adults (18-50 years) who can walk independently on a treadmill for at least 6 minutes
• Physical therapist (PT) with a license and experience in gait rehab (self-reported)

You may not qualify if:

• (1) For healthy study participants:
• Any neurological or orthopedic condition that can affect walking (Self-reported)
• Uncontrolled cardiovascular or metabolic condition that can affect walking (Self-reported)
• Current lower-limb pain or discomfort
• Lower-limb surgery within the past six months
• On medications that may impair balance (Self-reported)
• Open wound in the lower limb
• (2) For PT:
• Not having license
• No experience in gait rehab

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Related Publications (4)

• Zbytniewska M, Kanzler CM, Jordan L, Salzmann C, Liepert J, Lambercy O, Gassert R. Reliable and valid robot-assisted assessments of hand proprioceptive, motor and sensorimotor impairments after stroke. J Neuroeng Rehabil. 2021 Jul 16;18(1):115. doi: 10.1186/s12984-021-00904-5.

  PMID: 34271954 BACKGROUND

• Giansanti D. The Social Robot in Rehabilitation and Assistance: What Is the Future? Healthcare (Basel). 2021 Feb 25;9(3):244. doi: 10.3390/healthcare9030244.

  PMID: 33668987 BACKGROUND

• Banyai AD, Brisan C. Robotics in Physical Rehabilitation: Systematic Review. Healthcare (Basel). 2024 Aug 29;12(17):1720. doi: 10.3390/healthcare12171720.

  PMID: 39273744 BACKGROUND

• Jing Q, Xing Y, Duan M, Guo P, Cai W, Gao Q, Gao R, Ji L, Lu J. Study on the Rehabilitation Therapist Estimation Under Institutional Perspective by Applying the Workload Indicators of Staffing Needs in the Aging Context. Front Public Health. 2022 Jun 16;10:929675. doi: 10.3389/fpubh.2022.929675. eCollection 2022.

  PMID: 35784252 BACKGROUND

Study Officials

• Hao-Yuan Hsiao, PhD

  University of Austin at Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mac Prible, PhD

CONTACT

6466208829; prible@utexas.edu

Sonu Maharjan, MS

CONTACT

6823743674; sm86245@my.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 23, 2026
• Study Start: March 26, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)