Activities of Daily Living (ADL) Virtual Reality (VR) for Acquired Brain Injury (ABI) Upper-Limb Rehabilitation

NCT ID: NCT07026630

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-05-31

Brief Summary

Acquired brain injury (ABI) individuals have shown greater engagement and functional recovery when trained in virtual reality (VR)-assisted rehabilitation therapies.

After developing an activities of daily living (ADL)-focused VR system in a prior study, this related follow-up study aims to test the efficacy and impact of this VR system on upper-limb rehabilitation outcomes of ABI individuals when routinely integrated into treatment plans.

Detailed Description

After completion of informed consent, patients will undergo screening assessments to determine eligibility for study participation.

All eligible participants integrate VR into rehabilitation treatment plans twice per week for 12 weeks. Graphical complexity increases progressively throughout the study: "Simple" in Weeks 1-4, "Standard" in Weeks 5-8, and "Complex" in Weeks 9-12. Assessments are conducted at pre-intervention and post-intervention.

Conditions

Upper Limb Rehabilitation; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADL-Focused Virtual Reality

Participants will receive 24 one-hour rehabilitation sessions with a licensed occupational therapist trained in stroke recovery and with the VR system. Each therapy session will include range of motion and general strengthening activities as well as 20-30 minutes of the intervention (ADL-focused upper-limb virtual reality training). The goal is to complete rehabilitative training in 12 weeks, with each participant training two times per week.

Group Type: EXPERIMENTAL

Cooking In the Kitchen

Intervention Type: DEVICE

The virtual reality (VR) training tool simulates cooking, an activity of daily living (ADL). The layout of VR environments intentionally place ingredients, tools, and the recipe book far away from the user to require gross upper-limb physical movements. Successful step completion requires reaching to obtain ingredients or turn book pages, grabbing to hold or release objects, and chopping, scooping, stirring, and pouring motions to prepare food items. The VR tool includes three versions of varying graphical complexity: Simple, Standard, and Complex.

Complexity is controlled by stimuli count and detail level. For example, Simple features an empty room with monotone colors, basic shapes, and no extra features. In contrast, Complex resembles a fully-fledged kitchen with color patterns, textures, background details, and sounds.

Interventions

Cooking In the Kitchen

The virtual reality (VR) training tool simulates cooking, an activity of daily living (ADL). The layout of VR environments intentionally place ingredients, tools, and the recipe book far away from the user to require gross upper-limb physical movements. Successful step completion requires reaching to obtain ingredients or turn book pages, grabbing to hold or release objects, and chopping, scooping, stirring, and pouring motions to prepare food items. The VR tool includes three versions of varying graphical complexity: Simple, Standard, and Complex.

Complexity is controlled by stimuli count and detail level. For example, Simple features an empty room with monotone colors, basic shapes, and no extra features. In contrast, Complex resembles a fully-fledged kitchen with color patterns, textures, background details, and sounds.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• acquired brain injury with upper extremity impairment
• Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score of 20 points or more
• able to follow commands and instructions
• least 2 months post-stroke, in the subacute or chronic recovery phase

Exclusion Criteria

• contraindications that increase susceptibility to VR-related adverse events and/or prevent completion of training tasks, such as seizures, epilepsy, visual acuity deficits (besides glasses), vertigo, nystagmus, motion sensitivity, or other non-ABI conditions that impede upper limb movement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Indiana University Health

OTHER

Sponsor Role: collaborator

Responsible Party

Hee-Tae Jung

Assistant Professor, Health Informatics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee-Tae Jung, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Peter Altenburger, Ph.D., PT

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Indiana University Health, Neurorehabilitation & Robotics

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

23118

Identifier Type: -

Identifier Source: org_study_id