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.: PACTR202007589336711 Date of Approval: 14/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Physiotherapy as a Complimentary treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors with COVID-19: A Clinical-Controlled Study
Official scientific title Physiotherapy as a Complimentary Treatment in Reducing Odds of Developing Complications, Expedite Hospital Discharge and Death in Stroke Survivors Positive for COVID-19: A Clinical Controlled Study
Brief summary describing the background and objectives of the trial Background: Coronavirus (COVID-19) positive stroke survivors (SSv) with comorbidities faces possibility for mortality. Study reports success of physiotherapy in COVID-19 positive SSv with multiple comorbidities. Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and sex-matched non-stroke individuals with multiple comorbidities with COVID-19 status confirmed using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic acid content in the test sample (NA) will be recorded from the virology test results. Their exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes’ walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements will be taken at every three days intervals from admission to discharge from hospital-isolation. They will receive their normal treatments for COVID-19 in addition to daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video platforms will be used for the interactions between the physiotherapists and the participants. Pre-tested exercise protocol for stroke patients developed by the Stroke and Nervous System Disorders research group of the University of Lagos, Nigeria will be used for the E-exercises. The exercise package will be loaded into the phones of the participants at hospital admission. The Physiotherapists will lead in the exercises through video interaction will the participants watches the video programme. Their risks for respiratory complications (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval). Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence for inclusion of Physiotherapy in the acute management of individuals with COVID19
Type of trial CCT
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 13/07/2020
Actual trial start date 13/07/2020
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 Non-randomised Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Electronic Stroke Rehabilitation program in addition to their pharmacological treatment Daily intervention one hour wards. The Physiotherapy Procedures. The exercises are divided into head and neck exercises, upper limb functional performance, lower limb functional performance, trunk and abdomen rotation, balance and support system and chest and breathing exercises. The intervention exercises are functionally oriented. Each of the components of the exercises will be performed starting from 15 repetitions and progressed at 5 repetitions every 3-days. The exercises had been pre-recorded on audio-visual systems and transferable or can be installed in the phones of the patients. The video has been pre-tested and had been used for stroke patients and given to informal caregivers who are involved in home-assistance for stroke survivors by the Stroke and Nervous System Disorders Research Group of the University of Lagos, Nigeria and certified for content and ease of administration. Authorities in charge of all the involved isolation centres will be contacted and informed about the study. they will be used to identify the participants. Immediately after the identification, the electronic informed consent form will be sent to them and after signing, they will be enrolled in the study. The exercise package will then be sent to them after securing video contact with the prospective participant. Physiotherapy-Patients’ Engagements At every morning after their prescribed drugs have been served in the ward, the physiotherapist will call the patient for the exercises. The patient will be connected to the physiotherapist who is in his clinic (not in the isolation ward with the patients) through a WhatsApp or zoom video call. The physiotherapist will control the rhythm and pace of the exercises through the video interactions. Outcome Variables The outcome variables will be their cycle threshold and Nucleic acid values as recorded from the series of the qRT-PCR that will be obtained from the series of tests for the patients during isolation, normally, the test is done every 3 days interval. 15
Control Group Usual treatment for patients with CoViD19 apart from physiotherapy Daily as prescribed from admission to discharge Normal pharmacological treatment by physicians 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Stroke survivors positive for CoViD-19 and age, sex and co-morbid health status-matched CoViD positive individuals 2. The stroke survivors must have been discharge from in-patient stroke care unit 1. Must not primarily admitted for stroke or stroke complications 2. Must have been discharged from inpatient stroke care and must have been receiving outpatient rehabilitation for at least one month before diagnosis of COVID19 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 120 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 06/07/2020 Health Ethics Committee College of Medicine University of Lagos Nigeria
Ethics Committee Address
Street address City Postal code Country
Idi-Araba Lagos 2341 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Cycle Threshold and Number of Nucleic Acid from Quantitative Real Time Polymerase Chain Reaction. Baseline and at three days interval
Primary Outcome Exercise tolerance every other day from admission to discharge
Secondary Outcome Discharge At discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital and all the CoViD19 Isolation Cebtres in Lagos and Kano states Nigeria Idi-Araba, Lagos, Nigeria Lagos 234001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Caleb Ademola Omuwa Gbiri Department of Physiotherapy, College of Medicine, University of Lagos, Nigeria Lagos 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Caleb Ademola Omuwa Gbiri Idi-Araba Lagos 234001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Jibrin Sammani Usman College of Health Sciences, Bayero University Kano Nigeria Kano 234024 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caleb Gbiri cgbiri@unilag.edu.ng +2348033598072 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234001 Nigeria Senior Lecturer College of Medicine University of Lagos Nigeria
Role Name Email Phone Street address
Scientific Enquiries Caleb Gbiri cgbiri@unilag.edu.ng +2348033598072 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 234001 Nigeria Senior Lecturer College of Medicine University of Lagos Nigeria
Role Name Email Phone Street address
Public Enquiries Jibrin Usman jibrilphysio@yahoo.com +2348099995088 Bayero University Kano Nigeria
City Postal code Country Position/Affiliation
Kano 234019 Nigeria Lecturer College of Health Sciences Bayero University Kano Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The information about the clinical implication of the research will be communicated to the participants and the general public and research community Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 28 days after hospital isolation discharge Controlled: For Systematic Review and data comparison
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