Clinical trial NCT07026630: Activities of Daily Living (ADL) Virtual Reality (VR) for Acquired Brain Injury (ABI) Upper-Limb Rehabilitation
Official title: Validating the Efficacy of Activities of Daily Living (ADL)-Focused Virtual Reality (VR) in Upper-Limb Rehabilitation for Acquired Brain Injury (ABI) Individuals: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Upper Limb Rehabilitation
Stroke
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
First posted: 2025-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: Baseline (pre-intervention), Week 6, and End-of-Study (post-intervention, Week 13)
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)
measure: Lawton Instrumental Activities of Daily Living
timeFrame: Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)
Other outcomes:
measure: Mini-Mental State Examination
timeFrame: Baseline (pre-intervention)
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health, Neurorehabilitation & Robotics
state: Indiana
Study officials:
affiliation: Indiana University, Luddy School of Informatics, Computing, and Engineering
name: Hee-Tae Jung, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation
name: Peter Altenburger, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
References: