NCT07412899

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 22, 2026

Last Update Submit

February 9, 2026

Conditions

Keywords

immersive virtual realityFeasibility studyRehabilitation technologyAdaptRehab imVRUpper Limb RehabilitationStroke RehabilitationVirtual Reality TherapyMotor Recovery

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

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

Secondary Outcomes (3)

  • Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)

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

  • Action Research Arm Test (ARAT)

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

  • Box and Block Test (BBT)

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

Study Arms (1)

Immersive virtual reality

EXPERIMENTAL

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.

Interventions

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
Immersive virtual reality

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethiopia, Jimma University, Jimma University Teaching Hospital

Jimma, Oromiya, POBox : 378, Ethiopia

Location

Related Publications (3)

  • Kenea, C. D., Abessa, T. G., Lamba, D., & Bonnechère, B. (2025). 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-design approach. Bioengineering, 12(6), 581. https://doi.org/10.3390/bioengineering12060581

    BACKGROUND
  • Kenea, C. D., Abessa, T. G., Lamba, D., & Bonnechère, B. (2025). Immersive virtual reality in stroke rehabilitation: A systematic review and meta-analysis of its efficacy in upper limb recovery. Journal of Clinical Medicine, 14(6), 1783. https://doi.org/10.3390/jcm14061783

    BACKGROUND
  • Kenea, C.D, Gemechu Abessa, T., Lamba, D., & Bonnechère, B. (2024). Technological features of immersive virtual reality systems for upper limb stroke rehabilitation: A systematic review. Sensors, 24(11), 3546. https://doi.org/10.3390/s24113546

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bruno BONNECHERE, Rehabilitation Science

    Hasselt University

    PRINCIPAL INVESTIGATOR
  • Teklu Gemechu Abessa, Special Needs and Inclusive

    Jimma University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 17, 2026

Study Start

December 8, 2025

Primary Completion

March 26, 2026

Study Completion

April 10, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The IPD and supporting information will be made available after publication of the study or for purposes related to publication.
Access Criteria
The data may be shared with other researchers upon reasonable request, provided that the proposed use supports the advancement of scientific knowledge and aligns with the best interests of the study participants.

Locations