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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509819191628 Date of Registration: 26/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of an eight-week automobile simulator training on motor function, driving performance and community reintegration among stroke survivors in Abuja, Nigeria
Official scientific title EFFECTS OF AN EIGHT-WEEK AUTOMOBILE SIMULATOR TRAINING ON MOTOR FUNCTION, DRIVING PERFORMANCE AND COMMUNITY REINTEGRATION AMONG STROKE SURVIVORS IN ABUJA, NIGERIA
Brief summary describing the background and objectives of the trial The ability to resume driving post-stroke is associated with improved autonomy, enhanced social participation, and greater employability. However, the physical, cognitive, and psychological sequelae of stroke constitute barriers to resumption of driving. To address these barriers, automobile stimulators have emerged as an innovative tool for driving rehabilitation among stroke survivors. Studies on the effectiveness of simulator-based training among stroke survivors are from high-income countries, and findings may not be transferrable to Nigeria. Hence, the need to investigate the effects of simulator-based driving rehabilitation on motor function, driving performance and community reintegration among stroke survivors in Nigeria. The specific objectives are to: 1.compare the effects of an eight -week automobile simulator training and conventional physiotherapy on motor function, driving performance and community reintegration among stroke survivors with pre-stroke driving history in Abuja across baseline, 4th, and 8th week of simulator training, and 4 weeks post-intervention. 2.investigate the differences in motor function, driving performance, and cognition function between male and female stroke survivors, and across level of education, marital status and employment status across baseline, 4th, and 8th week of simulator training, and 4 weeks post-intervention. 3.investigate the association between driving performance and each of motor function, cognition, community reintegration, age, level of education and selected clinical variables of time since stroke onset, side of affectation and limb dominance, in stroke survivors with pre-stroke driving history in Abuja across baseline, 4th, and 8th week of simulator training, and 4 weeks post-intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 10/09/2025
Actual trial start date 22/09/2025
Anticipated date of last follow up 09/09/2026
Actual Last follow-up date 28/11/2026
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physiotherapy Dependent on treatment approaches of the physiotherapy clinics where they receive treatment Dependent on treatment approaches of the physiotherapy clinics where they receive treatment Participants in the Control group (CPG) will receive conventional physiotherapy only as intervention. This comprises exercises based of different treatment approaches used in rehabilitation of stroke patients by physiotherapists at the clinic. Intervention will be individualised and based on patients’ needs and priorities. 20 Active-Treatment of Control Group
Experimental Group Simulator based training Intervention will be twice weekly for eight weeks. Each session of simulator-based training will last 60minutes. The training will involve simulated driving tasks tailored to individual participant’s needs and abilities. The simulator provides automatic instantaneous feedback on errors made. Participants will also receive instruction and feedback from the researcher throughout the training sessions. Intervention will be twice weekly for eight weeks. Each session of simulator-based training will last 60minutes. While individual training programs will be varied according to the needs of each participant, the approach to training will be standardised. In addition to the simulator training which will be administered by the researcher, the participants will also receive conventional physiotherapy as required. This comprises exercises based on the different treatment approaches used in rehabilitation of stroke patients by physiotherapists at the clinic. The simulation training will be on a separate day from their conventional physiotherapy days. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Adults with first incident stroke with a minimum score of ≤ 3 on the Modified Rankin scale. 2.Stroke survivors who were licensed to drive and had been driving for ≥2years (competent drivers) prior to their stroke events. 3.Stroke survivors with visual acuity ≥20/40 magnification requirement (MAR) on the Snellen chart. 1.Stroke survivors with moderate to severe cognitive impairment based on a score of <24 on the Standard Mini-Mental State Examination (SMMSE). 2.Stroke survivors with severe hearing impairments that could impair their ability to perceive auditory cues during simulated driving tasks. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 10/10/2025 Institute for advanced medical research and training
Ethics Committee Address
Street address City Postal code Country
College of medicine, University of Ibadan Ibadan 200005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Motor function, driving performance and cognitive function. Baseline, 4th week, 8th week and 4 weeks post-intervention
Secondary Outcome Community reintegration, driving anxiety, Baseline, 4th week, 8th week and 4 weeks post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National hospital Abuja Plot 132 Central Business Districts PMB 425 Garki Abuja Abuja Nigeria
Fitness global consult physiotherapy clinic Abuja 25A Tennessee crescent, Maitama Abuja Nigeria
Maitama district hospital Abuja 61 Aguiyi Ironsi Street, Maitama Abuja Nigeria
University of Abuja teaching hospital Gwagwalada, P.M.B. 228, Abuja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Kingsley Obumneme Nwankwo 25A Tennessee crescent, Maitama Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kingsley Obumneme Nwankwo 25A Tennessee crescent, Maitama Abuja Nigeria Self-sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kingsley Nwankwo stallononline2000@yahoo.com 2348063652581 25A Tennessee crescent, Maitama.
City Postal code Country Position/Affiliation
Abuja Nigeria Ph.D candidate Department of physiotherapy college of medicine University of Ibadan
Role Name Email Phone Street address
Public Enquiries Simeon Nnaji uiuchec@gmail.com 2348067114881 2nd floor, room 210, IAMRAT, college of medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Research administrator institute for advanced medical research and training
Role Name Email Phone Street address
Scientific Enquiries Olubukola Olaleye olubukolaolaleye@yahoo.com 2348052145873 Department of Physiotherapy, faculty of clinical sciences, college of medicine, university of Ibadan.
City Postal code Country Position/Affiliation
Ibadan Nigeria senior lecturer and supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This will include sociodemographics (Gender, age, occupation, level of education and occupation) and clinical variables (time since stroke, side of affectation, limb dominance) of participants. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 9 months and 36 months after publication Data will be available indefinitely on a link that will be made available after publication
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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 Public title 26/09/2025 PACTR Admin EFFECTS OF AN EIGHT-WEEK AUTOMOBILE SIMULATOR TRAINING ON MOTOR FUNCTION, DRIVING PERFORMANCE AND COMMUNITY REINTEGRATION AMONG STROKE SURVIVORS IN ABUJA, NIGERIA Effects of an eight-week automobile simulator training on motor function, driving performance and community reintegration among stroke survivors in Abuja, Nigeria