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

Not Applicable

Not yet recruiting

• Conditions: Stroke; Upper Limb Rehabilitation

• Registration Number: NCT07026630
• Lead Sponsor: Indiana University

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment for Upper Extremity	Baseline (pre-intervention), Week 6, and End-of-Study (post-intervention, Week 13)	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.

Secondary Outcome Measures

Name	Time	Method
Stroke Impact Scale	Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)	The Stroke Impact Scale (SIS) holistically evaluates quality of life after a stroke. The SIS-16 version is a self-report questionnaire that assesses the ability to perform daily physical activities on a 5-point Likert scale.; Score ranges from 0 to 100, with higher scores indicating better capacity and milder stroke impact.
Lawton Instrumental Activities of Daily Living	Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)	The Lawton Instrumental Activities of Daily Living (IADL) Scale uses self-reported information to assess performance during independent living. Topics vary and include tasks such as phone use, shopping, housekeeping, and medication management.; Score ranges from 0 (low function and dependent) to 8 (high function and independent).; Scoring differs by gender due to known differences in IADL performance.

Trial Locations

Locations (1)

Indiana University Health, Neurorehabilitation & Robotics; 🇺🇸 Indianapolis, Indiana, United States