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IRB disapproved the study protocol on 13-Nov-2025
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| Name | Class |
|---|---|
| Indiana University Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale | 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. | Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13) |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination | The Mini-Mental State Examination (MMSE) is an 11-question cognitive performance assessment that evaluates orientation, understanding, language, attention, and memory. | Baseline (pre-intervention) |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health, Neurorehabilitation & Robotics | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Lawton Instrumental Activities of Daily Living | 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. | Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |