An interventional study of Virtual Reality Headset with immersive exercises. in Stroke, sponsored by Jimma University. Enrolling by invitation at 1 site in Ethiopia. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Jimma University · Not applicable, Interventional, and Treatment
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.
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 18 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Jimma University is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Device: Virtual Reality Headset with immersive exercises.
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.
Also known as: Oculus quest 2
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.
Time frame: The SUS will be assessed at Week 3 (post-intervention).
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.
Time frame: The UEQ will be assessed at Week 3 (post-intervention).
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.
Time frame: The simulator sickness questionnaire will be assessed at Week 3 (post-intervention).
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.
Time frame: The assessments will be conducted two times: Baseline (pre-intervention) and immediately post-intervention at Week 3.
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.
Time frame: The assessments will be conducted two times: Baseline (pre-intervention) and immediately post-intervention at Week 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.
Time frame: The assessments will be conducted two times: Baseline (pre-intervention) and immediately post-intervention at Week 3.
Plan to share: 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.
Supporting information: Study protocol, Icf, Csr
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