Usability of the Regen Gait Therapy Robot in Healthy Adults
ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Texas at Austin
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Regen Rehabilitation Assistive Device
DeviceRegen is a robotic gait therapy device that learns therapist-guided movement trajectories and autonomously reproduces them.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Regen-assisted gait feasibility and usability armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During the experimental session (Day 1) and immediately post-task (within 10 minutes after completion)2
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.
Time frame
During the experimental session (Day 1) and immediately post-task (within 10 minutes after completion)3
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.
Time frame
Immediately post-task (within 10 minutes after completion, Day 1)4
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.
Time frame
Immediately post-task (within 10 minutes after completion, Day 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov