Stroke, Upper Limb Rehabilitation
Conditions
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.
Interventions
DEVICECooking 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.
Sponsors
Indiana University Health
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination | Baseline (pre-intervention) | The Mini-Mental State Examination (MMSE) is an 11-question cognitive performance assessment that evaluates orientation, understanding, language, attention, and memory. |
Countries
United States
Outcome results
None listed