Upper Limb RehabilitationNCT07026630
Activities of Daily Living (ADL) Virtual Reality (VR) for Acquired Brain Injury (ABI) Upper-Limb Rehabilitation
A study testing Cooking In the Kitchen in people with Upper Limb Rehabilitation and Stroke, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Rehabilitation, Stroke
- What is being tested?
- Cooking In the Kitchen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to May 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health, Neurorehabilitation & Robotics
Indianapolis, Indiana, 46202
About this study
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
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.
Read the 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.
- Conditions
- Upper Limb Rehabilitation, Stroke
- Being tested
- Cooking In the Kitchen
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking In the KitchenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cooking In the Kitchen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention), Week 6, and End-of-Study (post-intervention, Week 13)
Secondary outcomes (2)
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.
Measured: Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)
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.
Measured: Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study startNov 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: IRB disapproved the study protocol on 13-Nov-2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb RehabilitationStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Hee-Tae Jung, Indiana University
- Investigators
- Hee-Tae Jung, Ph.D., Principal investigator, Indiana University, Luddy School of Informatics, Computing, and EngineeringPeter Altenburger, Ph.D., PT, Principal investigator, Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026630
- Sponsor's protocol ID
- 23118
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07026630
- Acronym / sponsor ID
- 23118
- Conditions
- Upper Limb Rehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB disapproved the study protocol on 13-Nov-2025
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- Nov 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADL-Focused Virtual Reality | Experimental | Device: Cooking In the KitchenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooking In the KitchenThe 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. | Device | ADL-Focused Virtual Reality |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity
Time frame: 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.
2 secondary outcomes
Stroke Impact Scale
Time frame: Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)
Lawton Instrumental Activities of Daily Living
Time frame: Baseline (pre-intervention) and End-of-Study (post-intervention, Week 13)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Upper Limb Rehabilitation
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Tae Jung, Ph.D. principal investigator
Indiana University, Luddy School of Informatics, Computing, and Engineering
Peter Altenburger, Ph.D., PT principal investigator
Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking In the Kitchen in people with Upper Limb Rehabilitation and Stroke, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for Upper Extremity (time frame: Baseline (pre-intervention), Week 6, and End-of-Study (post-intervention, Week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.