Recruiting

VR-assisted Gait Therapy vs. C-Mill

Sponsor:

Indiana University

Code:

NCT07038889

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

C-Mill VR+ by Motek

Walk-over-Ground

Study Details

Brief summary:

The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.

Conditions

Traumatic Brain Injury

Study ID

NCT07038889

Start date

Oct 9, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.
  • Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.
  • Exercise Clearance: Approval from a physician for participation in exercise-based interventions.
  • Rehabilitation Need: Demonstrates a need for functional rehabilitation.
  • Recent Therapy: Participants should not have received physical therapy (PT) within the last month.
  • Consent: Must be able to provide informed consent for themselves.

Exclusion Criteria:

  • Participants with unstable medication regimens that could interfere with their participation in the study.
  • Any comorbidity that could interfere with walking or gait training.
  • Participation in VR-assisted gait training within the last 6 months.
  • Intolerance to virtual reality environments or motion simulation.
  • Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.
  • More than 135 kg total body weight.
  • More than 2.00 meters in body height.
  • Presence of open skin lesions or bandages in areas that would come into contact with the harness.
  • Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.

Clarification:

\- The diagnosis of TBI can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VR-Assisted Overground Gait Therapy

Participants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Focus Vision, enabling participants to practice walking in real-world environments and gait tasks.

active comparator: Conventional Treadmill-Based VR Gait Therapy

Participants in the control group (VR-CTGT) will engage in gait training using C-Mill VR+ technology, which involves treadmill-assisted walking on a treadmill while interacting with less immersive virtual scenarios presented on screens.

Interventions

C-Mill VR+ by Motek

Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.

Walk-over-Ground

This intervention utilizes the HTC VIVE Focus Vision system for a realistic, fully immersive VR-assisted overground gait therapy. The immersive VR environment is designed to mimic real-world scenarios and challenges, enhancing the rehabilitation process by engaging patients in naturalistic gait activities.

Primary outcome measure

  • Step Count [ Time Frame: Continuous tracking from Screening to Week 10 ]
  • Travel Distance [ Time Frame: Continuous tracking from Screening to Week 10 ]
  • Activity Zone Minutes [ Time Frame: Continuous tracking from Screening to Week 10 ]

Central Contacts and Locations

Central contacts

Peter Altenburger, Ph.D., PT

317-278-0703paltenbu@iu.edu

Hee-Tae Jung, Ph.D.

317-278-1285heetjung@iu.edu

Locations

Indiana University Health, Neurorehabilitation & Robotics

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Peter Altenburger, Ph.D., PT

317-278-0703paltenbu@iu.edu

Kathryn Gyves, PT, DPT, NCS, CSRS, AVPT, CBIS

317-963-7050kgyves@iuhealth.org

Principal Investigator:

Peter Altenburger, Ph.D., PT

More Information

Sponsor

Indiana University

Last update posted

Oct 15, 2026

Last verified

Aug, 2026

Keywords

  • Gait Training
  • Virtual Reality
  • Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Indiana University on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.