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.: PACTR202407771478169 Date of Approval: 29/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Three Week Virtual Reality Game Training on Upper Limb Motor Recovery Among Stroke Survivors
Official scientific title Effects of Three Week Virtual Reality Game Training on Upper-Limb Motor Recovery Among Stroke Survivors: A Randomised Trial
Brief summary describing the background and objectives of the trial The high fatality rate of stroke in low-medium income countries (LMICs) has been attributed to limited access to rehabilitation services. This study examined the effect of Virtual Reality Gaming (VRG) on upper-limb motor function and its Activities of Daily Living (ADLs) among stroke survivors in a bid to reduce healthcare dependency.
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 10/10/2022
Actual trial start date 14/11/2022
Anticipated date of last follow up 13/02/2023
Actual Last follow-up date 10/01/2023
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 a randomization table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group CT Four times a week. Three weeks. Free active exercises, resisted active exercises, Proprioceptive Neuromuscular Facilitation Techniques, finger ladder exercises, weight bearing exercises, soft tissue massage using analgesic gels, Infrared therapy, thermotherapy using hydrocollator packs or ice packs, multi-gym exercises, and functional task training, as required for each patient. 15 Active-Treatment of Control Group
Experimental Group Virtual reality game training Bi-weekly, alongside Bi-weekly conventional therapies Three weeks Virtual reality gaming using the fit-XR gaming app on a Metaquest 2.0 system. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Stroke survivors between the ages of 30 and 85 years. ii. Stroke survivors at the sub-acute stage i.e. 2-6 months post stroke. iii. Stroke survivors with Gross Muscle Power (GMP) starting from 3 on the Oxford Muscle Grading Scale Testing on the affected upper limb. iv. Stroke survivors that have starting upper-limb function of the affected upper extremity with reduced spasticity i.e. stroke survivors between stages II and VI on the Brunnstrom scale of stroke recovery. v. Stroke survivors that have only had one stroke episode. i. Stroke survivors suffering from failure of critical organs. ii. Stroke survivors that have had more than one stroke episode. iii. Stroke survivors with a grip strength of 20mmHg and below using a modified sphygmomanometer on the affected upper limb. iv. Stroke survivors who suffer from mental illness, claustrophobia, motion sickness, vertigo or dizziness. v. Stroke survivors with visual impairments. vi. Stroke survivors who are photosensitive. vii. Stroke survivors with history of seizures, recent brain surgery or epilepsy. viii. Stroke survivors enrolled in another clinical trial involving physical therapy or an investigational drug. Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 85 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 15/11/2022 Ethics and Research Committee Obafemi Awolowo University Teaching Hospitals Complex.
Ethics Committee Address
Street address City Postal code Country
Ile-Ife Ile-Ife 5538 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fugl Meyer Assessment of Upper Extremity (FMA-UE) At the start of the study, and at three weeks.
Secondary Outcome Medical Research Council (MRC) Scale Start of the study, and at three weeks.
Secondary Outcome Upper Extremity Functional Index (UEFI) Start of the study, and at three weeks.
Secondary Outcome Wolf Motor Function Test (WMFT): Start of the study, and at three weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Complex. Ilesa road Ile Ife 5538 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nil Nil Nil Nil Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ejafu Benedicta Mary Chioma Ifesowapo Zone-D, Airport, Alakia, Ibadan. Ibadan 200235 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Egwu Egwumo@yahoo.com +2348033739499 Department of Medical Rehabilitation, Faculty of Basic Medical Sciences, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile Ife 220101 Nigeria Head of Department
Role Name Email Phone Street address
Public Enquiries Benedicta Ejafu ejafubenedicta2000@gmail.com +2247033062194 Department of Medical Rehabilitation, Faculty of Basic Medical Sciences, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile Ife 220101 Nigeria Intern
Role Name Email Phone Street address
Scientific Enquiries Benedicta Ejafu ejafubenedicta2000@gmail.com +2347033062194 Department of Medical Rehabilitation, Faculty of Basic Medical Sciences, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile Ife 220101 Nigeria Intern
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be available. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date. Researchers who provide a methodologically sound proposal will be given access to the data for individual participant meta-analysis. Proposal should be directed to ejafubenedicta2000@gmail.com. To gain access, data requestors will need to sign a data access agreement, which will be provided through the email given above. Data are available for 5 years and will be sent on request.
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