Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202602851104296 Date of Registration: 26/02/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Can Virtual Reality Help Stroke Patients Regain Strength, Balance, and Movement?
Official scientific title Effectiveness of Virtual Reality Based Rehabilitation on Motor Recovery Among Stroke Survivors in a Tertiary Health Institution in Benin City
Brief summary describing the background and objectives of the trial Stroke is a leading cause of long-term disability worldwide, often resulting in impaired motor function that limits independence and quality of life. Conventional physiotherapy remains the cornerstone of rehabilitation; however, recovery could be slow and incomplete. Virtual reality (VR) therapy has emerged as an innovative approach that provides task-oriented, engaging, and repetitive training, which may enhance neuroplasticity and functional outcomes. Despite its growing use globally, there is limited clinical evidence on its effectiveness in the Nigerian context. This trial aims to evaluate the effectiveness of virtual reality therapy on motor recovery among stroke survivors undergoing rehabilitation at the University of Benin Teaching Hospital. Specifically, the study will assess improvements in muscle strength, endurance, joint flexibility, balance, and coordination following VR therapy compared with conventional physiotherapy. The findings are expected to provide evidence on the potential of VR as a complementary rehabilitation tool to improve functional outcomes in stroke survivors in Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/05/2025
Actual trial start date
Anticipated date of last follow up 03/10/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional Physiotherapy Intervention Three times weekly. Eight weeks Participants in the control group will receive conventional physiotherapy for stroke rehabilitation, as routinely provided at the University of Benin Teaching Hospital. The sessions will include therapist-guided exercises aimed at improving muscle strength, endurance, joint flexibility/range of motion, balance, and coordination. Each session will last approximately 30 minutes, conducted thrice weekly for 8 weeks. The content of therapy will follow standard physiotherapy practice for stroke survivors, without the use of virtual reality technology. 20 Active-Treatment of Control Group
Experimental Group Conventional Physiotherapy Intervention plus Virtual Reality Three times per week. Eight weeks Participants in the experimental group will receive virtual reality-based physiotherapy in addition to conventional rehabilitation intervention. The sessions will involve engaging, task-oriented virtual reality activities designed to stimulate upper and lower limb motor function, improve balance, coordination, muscle strength, endurance, and joint flexibility/range of motion. Each session will last approximately 30 minutes, conducted thrice weekly for 8 weeks. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 18 to 65 years. Stroke survivors undergoing rehabilitation at UBTH. Presence of residual motor impairment (e.g., hemiparesis affecting the arm and/or leg). Medically stable and able to engage in exercise therapy Ability to give informed consent and willingness to participate in either VR or conventional therapy sessions for 8 weeks. Severe cognitive or communication impairment (e.g., advanced dementia or expressive/receptive aphasia). Significant visual or sensory deficits (e.g., profound visual impairment, severe proprioceptive or vestibular disorders). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/07/2025 Health Research Ethics Committee University of Benin Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ugbowo Lagos Road Benin 300283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in upper limb muscle strength of targeted muscle groups (shoulder flexors/extensors, elbow flexors/extensors, wrist flexors/extensors) on the affected side. Baseline and end of 8 weeks
Primary Outcome Change in lower limb muscle strength of targeted muscle groups (hip flexors/extensors, knee flexors/extensors, and ankle flexors/extensors) on the affected side. Medical Research Council Scale. Baseline and end of 8 weeks
Secondary Outcome Upper limb muscular endurance on the affected side to measure change from baseline. Measurement: modified 30-second arm curl test (number of repetitions completed). Baseline and end of 8 weeks
Secondary Outcome Lower limb muscular endurance on the affected side to measure change from baseline. Measurement: 30-second sit-to-stand test (number of stands). Baseline and end of 8 weeks
Secondary Outcome Upper limb joint flexibility (range of motion) Description: Change from baseline in active range of motion (ROM) of targeted joints on the affected side. Measurement: Universal goniometer; ROM reported in degrees for each joint (shoulder flexion/extension, elbow flexion, and wrist flexion/extension). Baseline and end of 8 weeks
Secondary Outcome Lower limb joint flexibility (range of motion) Description: Change from baseline in the active range of motion (ROM) of targeted joints on the affected side. Measurement instrument: Universal goniometer; ROM reported in degrees for each joint (hip flexion/extension, knee flexion, and ankle flexion/extension). Baseline and end of 8 weeks
Secondary Outcome Upper-limb coordination Description: Change from baseline in upper-limb coordination of the affected side. Rapid Alternating Movement Test (forearm pronation–supination); number of repetitions completed within 30 seconds. Baseline and end of 8 weeks
Secondary Outcome Lower-limb coordination Description: Change from baseline in lower-limb coordination of the affected side. Heel-to-Shin Test; number of successful repetitions performed within 30 seconds. Baseline and end of 8 weeks
Secondary Outcome Balance Description: Change from baseline in standing and functional balance. Measurement instrument: Berg Balance Scale (BBS), total score (0–56). Baseline and end of 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital Ugbowo Lagos Road, P.M.B 1111 Benin 300283 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Zabdiel Uti Off Newton Street, Ekosodin, Ugbowo Benin 300213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zabdiel Uti Newton Street, Ekosodin Benin 300213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zabdiel Uti utizabdiel@gmail.com +2348136497282 Newton street, Ekosodin
City Postal code Country Position/Affiliation
Benin 300213 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Adebisi Hammed h.adebisi@ubth.org +2347062982124 Ododo Street
City Postal code Country Position/Affiliation
Benin Nigeria Research Supervisor
Role Name Email Phone Street address
Public Enquiries Zabdiel Uti Uti utizabdiel@gmail.com +2348136497282 Newton Street, Ekososin
City Postal code Country Position/Affiliation
Benin 300213 Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in the primary publication, including baseline characteristics, intervention details, outcome measures, and adverse event data, will be shared. Statistical Analysis Plan,Study Protocol Data will be available after primary results are published with no end date. Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to the principal investigator. Data access will require a signed data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be provided upon publication. No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 04/03/2026 PACTR Admin 05 May 2025