Recruiting

Regen

Sponsor:

University of Texas at Austin

Code:

NCT07547683

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Regen Rehabilitation Assistive Device

Study Details

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

Study ID

NCT07547683

Start date

Mar 26, 2026

Status verified date

Apr, 2026

Completion date

Jun 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

(1) For healthy study participants:

1. Any neurological or orthopedic condition that can affect walking (Self-reported)
2. Uncontrolled cardiovascular or metabolic condition that can affect walking (Self-reported)
3. Current lower-limb pain or discomfort
4. Lower-limb surgery within the past six months
5. On medications that may impair balance (Self-reported)
6. Open wound in the lower limb

(2) For PT:

1. Not having license
2. No experience in gait rehab

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Regen-assisted gait feasibility and usability arm

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.

Interventions

Regen Rehabilitation Assistive Device

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

Primary outcome measure

  • System Usability Scale (SUS) [ Time Frame: During the experimental session (Day 1) and immediately post-task (within 10 minutes after completion) ]
  • NASA Task Load Index (NASA-TLX) [ Time Frame: During the experimental session (Day 1) and immediately post-task (within 10 minutes after completion) ]
  • Device Acceptability (Likert Scale) [ Time Frame: Immediately post-task (within 10 minutes after completion, Day 1) ]
  • Qualitative Feedback on Device Usability and Safety [ Time Frame: Immediately post-task (within 10 minutes after completion, Day 1) ]

Central Contacts and Locations

Central contacts

Mac Prible, PhD

6466208829prible@utexas.edu

Sonu Maharjan, MS

6823743674sm86245@my.utexas.edu

Locations

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

More Information

Sponsor

University of Texas at Austin

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-04-23.