AzTrials
AzTrials

StrokeimVRNCT07412899

AdaptRehab imVR: Exploring the Feasibility of imVR for Upper Limb Stroke Rehabilitation in Ethiopia

A study testing Virtual Reality Headset with immersive exercises. in people with Stroke, run by Jimma University at 1 site in Ethiopia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Stroke is a major cause of long-term disability worldwide, particularly in low- and middle-income countries (LMICs). Upper limb impairments following stroke can substantially limit an individual's ability to perform daily activities and engage in community life. Read more about this study

Who is it for?
Ages 18 months and older
Conditions the study is for
Stroke
What is being tested?
Virtual Reality Headset with immersive exercises.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteEthiopia
Study dates
8 Dec 2025to 10 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adults aged 18 years and older.
  • Diagnosed with ischemic or hemorrhagic stroke.
  • Stroke onset within the previous six months and more.
  • Presence of upper-limb impairment.
  • In the subacute or chronic stage of stroke recovery.
  • Medically stable at the time of participation.
  • Able to understand and follow instructions.
  • Adequate cognitive and visual abilities to interact with the AdaptRehab im VR system.

Who cannot join

  • Diagnosed severe cognitive impairment.
  • Diagnosed significant visual impairment that interferes with imVR interaction.
  • Presence of a severe psychological or psychiatric disorder.
  • Any medical condition that would prevent safe participation in proposed AdaptRehab imVR
  • Not medically stable or unable to safely engage in AdaptRehab imVR (example age).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ethiopia1 site
  • Ethiopia, Jimma University, Jimma University Teaching Hospital

    Jimma, Oromiya, POBox : 378

Other trials in Ethiopia

About this study

Stroke is a major cause of long-term disability worldwide, particularly in low- and middle-income countries (LMICs). Upper limb impairments following stroke can substantially limit an individual's ability to perform daily activities and engage in community life. Traditional rehabilitation approaches often require high levels of patient engagement and adherence, which can be challenging. Immersive Virtual Reality (imVR) systems offer a promising alternative by enhancing motivation and engagement, thereby supporting upper limb recovery. This study aims to assess the feasibility of the AdaptRehab imVR system in the Ethiopian context, providing valuable insights to guide the design of a future randomized controlled trial.

Read the detailed description

Background: Stroke represents a significant global health burden, affecting fifteen million individuals annually and causing over 5.5 million deaths worldwide. Fifty to eighty percent of stroke survivors experience upper-limb impairment. These disabilities may limit an individual's ability to take care of themselves, participate fully in social and community-related work, or engage in leisure activities leading to profound consequences.

New technology could be a potential solution to increase the provision of rehabilitation services despite the shortage of healthcare professionals, especially in LMICs. Amongst the different technologies, one of the most promising one, for stroke rehabilitation is immersive Virtual Reality (imVR). imVR has been shown to be effective in rehabilitation by reducing pain, accelerating recovery times, providing realistic environments, decreasing dependence on rehabilitation personnel, enabling increased treatment intensity and frequency, facilitating creative treatment delivery, standardizing therapeutic activities, and improving overall recovery outcomes. Key features include real-time feedback; customizable and adaptive environments enhanced motivation, safe and controlled environments, and multisensory stimulation including visual, auditory, and haptic feedback. Additionally, imVR facilitates essential repetitive exercises, with numerous studies demonstrating its effectiveness in stroke rehabilitation. Furthermore, recent studies have demonstrated the feasibility of implementing advanced rehabilitation technologies in LMICs, suggesting potential for significant enhancement of rehabilitation services in regions facing professional shortages. However, the implementation of imVR in healthcare, particularly for rehabilitation in LMICs, faces multiple significant challenges. These include shortage of rehabilitation services and technologies, existing imVR applications, primarily designed for HICs, often fail to address LMIC-specific needs and local technical realities such as cultural sensitivity issues, proprietary restrictions, and frequent technological updates. These challenges are compounded by limited research on effectiveness in LMIC contexts, and significant cultural and language barriers, as most systems are designed in English. In addition, currently there are no commercially available imVR solutions incorporating local cultural factors. This study is important as there is limited prior research on the specific intervention technique used and to consider the sociocultural health beliefs of the target population. The lack of data on the intervention in the particular context makes this study a significant contribution to the field. The study will offer important insights to guide the design and execution of a larger-scale randomized controlled trial by evaluating the effectiveness, usability, user experience cybersickness and acceptability of the AdaptRehab imVR system. Therefore, this study is objective is to conduct the feasibility study of the potential use of the AdaptRehab VR system for upper limb rehabilitation among stroke patients in Jimma, Southwest Ethiopia.

Specific Aims. (1) assess the usability of the Adapt imVR system, (2) To evaluate the user experience of the AdaptRehab imVR system,(3) examine the occurrence and severity of cybersickness associated with the AdaptRehab imVR system and (4) explore the acceptability of the AdaptRehab imVR system among patients and therapists and (5) evaluate the effectiveness of the AdaptRehab imVR system using upper-extremity outcome measures, including the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) , Action Research Arm Test (ARAT), and Box and Block Test (BBT).

Methodology. A mixed methods design approach will be used. The data will be included both quantitative and qualitative data. The quantitative includes upper extremity outcome measures, usability, user experience and cybersickness while qualitative will be the acceptability of the system using interview and focus group discussion. The proposed study's overall reporting and methodology adhere to CONSORT 2010 Extension for Pilot and Feasibility Studies (Non-Randomized). The study will be carried out in the physiotherapy clinic center of the Jimma University Teaching Hospital in Jimma, southwest Ethiopia. After reviewing their medical records and determining their eligibility, adults (age greater than 18) who present to the study setting with subacute and chronic, and those who consent to be contacted for research will be recruited. The therapists will collect the baseline data and post intervention data from the participants such upper extremity outcome measures, usability, user experience and cybersickness. Qualitative data will also be collected from all physiotherapists and nurses providing therapy services at the JUTH physiotherapy clinic to get their reflection on the proposed AdaptRehab VR system suitability and acceptability for stroke patients' upper limb rehabilitation. The sample size for this feasibility study is justified based on the estimated patient flow in the study context and the need to obtain sufficient data on the feasibility and acceptability of the intervention. The study plans to recruit 20 stroke patients over 3 weeks, considering a 15% non-participation rate and a 15% exclusion rate. Additionally, based on their consent, we will include all physiotherapists and trained nurses providing therapy services at the JUTH physiotherapy clinic.

Conditions
Stroke
Being tested
Virtual Reality Headset with immersive exercises.
Keywords
immersive virtual reality, Feasibility study, Rehabilitation technology, AdaptRehab imVR, Upper Limb Rehabilitation, Stroke Rehabilitation, Virtual Reality Therapy, Motor Recovery
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Headset with immersive exercises.Device

    Also called Oculus quest 2

    Participants in this arm will receive AdaptRehab imVR therapy for upper limb stroke rehabilitation. Therapy will be delivered over nine sessions across three weeks. Sessions involve interactive, task-oriented exercises in an immersive VR environment, designed to improve upper limb motor function. Participants' usability, user experience, and cybersickness will be assessed as primary outcomes, while FMA, ARAT, and BBT scores will be collected as secondary outcomes.

Study groups in NCT07412899
Study groupRoleWhat they receive
Immersive virtual realityExperimentalParticipants in this arm will receive AdaptRehab imVR therapy for upper limb stroke rehabilitation. Therapy will be delivered over nine sessions across three weeks. Sessions involve interactive, task-oriented exercises in an immersive VR environment, designed to improve upper limb motor function. Participants' usability, user experience, and cybersickness will be assessed as primary outcomes, while FMA, ARAT, and BBT scores will be collected as secondary outcomes.
Receives: Device: Virtual Reality Headset with immersive exercises.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. System Usability Scale (SUS)

    The SUS will be conducted at the end of the intervention, after the 9 sessions, by the therapists from the participants. The SUS consists of 10 questions with 5 response options based on a Likert scale.

    Measured: The SUS will be assessed at Week 3 (post-intervention).

  2. User experience questionnaire (UEQ)

    The UEQ uses a 7-point scale ranging from 1 to 7, for example, from unattractive to attractive. On this scale, [1] represents extremely negative / completely unattractive, [2] represents very negative / mostly unattractive, [3] represents moderately negative / somewhat unattractive,[4] represents neutral / neither attractive nor unattractive, [5] represents moderately positive / somewhat attractive, [6] represents very positive / mostly attractive, and [7] represents extremely positive / completely attractive. The UEQ consists of 26 questions and will be completed by the therapists from the participants at the end of the intervention.

    Measured: The UEQ will be assessed at Week 3 (post-intervention).

  3. Simulator Sickness Questionnaire

    The Simulator Sickness Questionnaire also conducted at the end of intervention. The data will be collected from participants by the therapists. The therapists rate how much each listed symptoms such as general discomfort, fatigue, headache and eyestrain are affecting them at that moment using a 4-point scale: 0 = not at all, 1 = mild, 2 = moderate and 3 = severe.

    Measured: The simulator sickness questionnaire will be assessed at Week 3 (post-intervention).

Secondary outcomes (3)
  1. Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)

    FMA-UE is one of the most widely used tools for evaluating upper limb function in stroke patients with upper extremity impairments. It comprises seven subdomains: Upper Extremity (0-36), Wrist (0-10), Hand (0-14), and Coordination/Speed (0-6), which together form the total motor function score (0-66). Additional subdomains assess Sensation (0-12), Passive Joint Motion (0-24), and Joint Pain (0-24). The assessments will be performed by the participants' physiotherapists. Higher scores in each subdomain indicate greater improvement in upper extremity function.

    Measured: The assessments will be conducted two times: Baseline (pre-intervention) and immediately post-intervention at Week 3.

  2. Action Research Arm Test (ARAT)

    ARAT is another commonly used tool for assessing upper extremity function. It consists of four subtests: Grasp, Grip, Pinch, and Gross Movement, with the following score ranges: Grasp (0-18), Grip (0-12), Pinch (0-18), and Gross Movement (0-9). A total score is calculated by summing the scores of all subdomains (range: 0-57), with higher scores indicating better hand dexterity.

    Measured: The assessments will be conducted two times: Baseline (pre-intervention) and immediately post-intervention at Week 3.

  3. Box and Block Test (BBT)

    The BBT is a widely used assessment of manual dexterity. It measures how many blocks a participant can transfer, one at a time, from one compartment of a box to another within 60 seconds. A higher number of blocks transferred indicate better hand and arm dexterity. The test is simple, quick to administer, and is commonly used in studies evaluating upper extremity function in stroke and rehabilitation settings.

    Measured: The assessments will be conducted two times: Baseline (pre-intervention) and immediately post-intervention at Week 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start8 Dec 2025
  3. Primary completion26 Mar 2026 (estimated)
  4. Study completion10 Apr 2026 (estimated)

Resources

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
Model description
This is a single-arm, interventional feasibility study designed to evaluate the use of AdaptRehab imVR for upper limb stroke rehabilitation. Participants will receive immersive virtual reality-based therapy over three weeks, totaling nine sessions, with no comparator or control group. The study will assess feasibility outcomes, including usability, user experience, and cybersickness as primary outcomes, and upper limb functional outcomes measured by FMA, ARAT, and BBT as secondary outcomes. Allocation is non-randomized, and the study is open-label, meaning that both participants and investigators are aware of the intervention.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412899
Sponsor's protocol ID
JimmaUniversity
Acronym
imVR
Status last verified
Feb 2026
First submitted
22 Jan 2026
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data on participants' usability, user experience, and cybersickness (primary outcomes), as well as FMA, ARAT, and BBT scores (secondary outcomes), will be shared upon request when needed.

Publications

  • Kenea CD, Abessa TG, Lamba D, Bonnechere B. AdaptRehab VR: Development of an Immersive Virtual Reality System for Upper Limb Stroke Rehabilitation Designed for Low- and Middle-Income Countries Using a Participatory Co-Creation Approach. Bioengineering (Basel). 2025 May 28;12(6):581. doi: 10.3390/bioengineering12060581.

    PubMed 40564398
  • Kenea CD, Abessa TG, Lamba D, Bonnechere B. Immersive Virtual Reality in Stroke Rehabilitation: A Systematic Review and Meta-Analysis of Its Efficacy in Upper Limb Recovery. J Clin Med. 2025 Mar 7;14(6):1783. doi: 10.3390/jcm14061783.

    PubMed 40142592
  • Diriba Kenea C, Gemechu Abessa T, Lamba D, Bonnechere B. Technological Features of Immersive Virtual Reality Systems for Upper Limb Stroke Rehabilitation: A Systematic Review. Sensors (Basel). 2024 May 31;24(11):3546. doi: 10.3390/s24113546.

    PubMed 38894337
  • Kenea CD, Abessa TG, Lamba D, Bonnechere B. Feasibility, acceptability, and preliminary efficacy of AdaptRehab VR, an immersive virtual reality system for upper limb stroke rehabilitation: A mixed-methods study in Ethiopia. PLoS One. 2026 Oct 9;21(10):e0360216. doi: 10.1371/journal.pone.0360216. eCollection 2026.

    PubMed 42853792

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Headset with immersive exercises. in people with Stroke, run by Jimma University at 1 site in Ethiopia.

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 8 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. 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 Ethiopia. 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?

This study is still under way. Results are not available in the source record yet.

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?

System Usability Scale (SUS) (time frame: The SUS will be assessed at Week 3 (post-intervention).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412899, which also lists 4 linked publications.

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 17 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in