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

Официальное название

Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)

Обзор

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.

Подробное описание

After obtaining consent and screening, eligible participants are randomized to the treatment or control groups.

First, all participants are issued a wearable tracker to gauge baseline activity for at least 5 days.

During the intervention phase, participants undergo 12 treatment sessions, 2x a week for 6 weeks.

Assessments are conducted at pre-intervention, post-intervention, and 1-month followup.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

• 10-Meter Walk Test [Срок оценки: Baseline, Week 7, Week 10]
• 6-Minute Walk Test [Срок оценки: Baseline, Week 7, Week 10]
• Dynamic Gait Index [Срок оценки: Baseline, Week 7, Week 10]
• Timed Up and Go Test [Срок оценки: Baseline, Week 7, Week 10]
• Step-Over Test [Срок оценки: Baseline, Week 7, Week 10]
• Step Length [Срок оценки: Baseline, Week 7, Week 10]
• Stride Length [Срок оценки: Baseline, Week 7, Week 10]
• Stance Percentage [Срок оценки: Baseline, Week 7, Week 10]
• Gait Speed [Срок оценки: Baseline, Week 7, Week 10]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Indiana University Health, Neurorehabilitation & Robotics — Indianapolis

Идентификаторы

NCT: NCT07038889 · 25423

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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