Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)

NCT07038889 | Not Yet Recruiting FDA Device

• 1 other identifier: 25423
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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; Stroke; Gait Training

Outcome Measures

Primary Outcomes (3)

• Step Count

  FitBit tracks the number of steps (count) taken by participant.

  Continuous tracking from Screening to Week 10

• Travel Distance

  FitBit tracks the total distance (miles) travelled by participant.

  Continuous tracking from Screening to Week 10

• Activity Zone Minutes

  Fitbit calculates maximum heart rate (HR) from user age (Max HR = 220 - age) and defines Activity Zone thresholds based on percentages of max HR (Fat Burn 50-69%, Cardio/Peak \>70%). Activity Zone Minutes (AZMs) are an intensity-weighted measure of activity. AZM (count) is based on sustained heart rate over time: 1 AZM per minute in the Fat Burn Zone (50-69% max HR) and 2 AZMs per minute in the Cardio/Peak Zones (\>=70% max HR).

  Continuous tracking from Screening to Week 10

Secondary Outcomes (9)

• 10-Meter Walk Test

  Baseline, Week 7, Week 10

• 6-Minute Walk Test

  Baseline, Week 7, Week 10

• Dynamic Gait Index

  Baseline, Week 7, Week 10

• Timed Up and Go Test

  Baseline, Week 7, Week 10

• Step-Over Test

  Baseline, Week 7, Week 10

Other Outcomes (3)

• Quality of Life after Brain Injury

  Baseline, Week 7, Week 10

• Disability Rating Scale

  Screening, Baseline, Week 7, Week 10

• Mini-Mental State Examination

  Screening

Study Arms (2)

VR-Assisted Overground Gait Therapy

EXPERIMENTAL

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 Pro 2, enabling participants to practice walking in real-world environments and gait tasks.

Device: Walk-over-Ground

Conventional Treadmill-Based VR Gait Therapy

ACTIVE COMPARATOR

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.

Device: C-Mill VR+ by Motek

Interventions

C-Mill VR+ by Motek DEVICE

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

Conventional Treadmill-Based VR Gait Therapy

Walk-over-Ground DEVICE

This intervention utilizes the HTC VIVE Pro 2 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.

VR-Assisted Overground Gait Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI) or stroke, confirmed by the referring neurologist.
• Cognitive Function: Mini-Mental State Examination (MMSE) score greater than 24, indicating sufficient cognitive function to participate in the study.
• Exercise Clearance: Approval from a neurologist 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.

You may not qualify if:

• 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 or stroke can be confirmed by their neurologist or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a neurologist to ensure it meets the study's medical criteria.

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University Health, Neurorehabilitation & Robotics

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hee-Tae Jung, Ph.D.

  Indiana University, Luddy School of Informatics, Computing, and Engineering

  PRINCIPAL INVESTIGATOR

• Peter Altenburger, Ph.D., PT

  Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Altenburger, Ph.D., PT

CONTACT

317-278-0703; paltenbu@iu.edu

Hee-Tae Jung, Ph.D.

CONTACT

317-278-1285; heetjung@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Health Informatics

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 26, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-12

Locations

US (1)