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

NCT07026630 | Withdrawn

• 1 other identifier: 23118
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Rehabilitation; Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment for Upper Extremity

  The Fugl-Meyer Assessment (FMA) is a physical performance impairment index that evaluates motor recovery. Domains of motor function, sensation, balance, range of motion, and pain are measured on a 3-point ordinal scale. The upper extremity (UE) section score ranges from 0 to 66, with higher scores indicating less impairment.

  Baseline (pre-intervention), Week 6, and End-of-Study (post-intervention, Week 13)

Secondary Outcomes (2)

• Stroke Impact Scale

  Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)

• Lawton Instrumental Activities of Daily Living

  Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)

Other Outcomes (1)

• Mini-Mental State Examination

  Baseline (pre-intervention)

Study Arms (1)

ADL-Focused Virtual Reality

EXPERIMENTAL

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.

Device: Cooking In the Kitchen

Interventions

Cooking In the Kitchen 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.

ADL-Focused Virtual Reality

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \- 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

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

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Health Informatics

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)