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.: PACTR202001714888482 Date of Approval: 27/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Multimodal physical activity for chronic stroke survivors
Official scientific title Combined and collective physical activity for chronic stroke survivors; the CBCS: Protocol for a randomized controlled trial
Brief summary describing the background and objectives of the trial Post-stroke disability leads victims to physical inactivity, which is explained by several factors related to the stroke. These factors have been identified as the causes and consequences of functional declines and health problems. Therefore, it is important to increase community physical activity levels and reduce the time spent in low-energy expenditure activities after a stroke. Although several types of physical activity (treadmill, robot assisted training, balance training, resistance training…) have been shown to be effective for the functioning of stroke survivors, their modalities of achievement were trial dependent and require equipment that is sometimes too expensive. To our knowledge, the effect of a combination of more than 2 types of physical activity, performed in a group and in a structured and fun way has not yet been highlighted. It may be important to investigate whether collective physical activity “Circuit walking, balance, cycling and strengthening trainings” (CBCS) is effective in improving ICF components (impairments, activity and participation).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CBCS
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 03/02/2020
Actual trial start date 03/02/2020
Anticipated date of last follow up 02/11/2020
Actual Last follow-up date 02/11/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 46
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CBCS 3sessions/week, 36 sessions 120min/session, 3 months • warm up and stretching: 30 min • Circuit Walking: brisk walking in a group of 6 to 8 subjects during a half hour • Recreational activity (strengthening, balance and coordination exercises): sit to stand in various environments (stable, unstable), Fill different objects (different shapes and weights) in a cart with wheels, push the cart.....: 30min • Cycling: a half hour on a motomed (30min) 23
Control Group Sociocultural group 3 sessions/week; 36 sessions 120min/session, 3 months This is a passive socio-cultural activity: • Board games (Checkers, Awalé ) • Theater or cultural show • hold a cultural speech 23 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Chronic stage of stroke (minimum 6 months after the first stroke) • Adults (18-75 years old) • Absence of cognitive impairment and dementia: CSI-D≥7 • Non-depressed patients: HADS≤7 • Less disabled patient: MRS≤3 • Not associated to other interventions related to walking and / or any form of physical activity • Sufficient mobility: able to walk 10 m alone or with a technical assistance • Diseases or Comorbidities that prevent the patient from participating in group-based physical activity • Contraindication to physical activity Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 02/01/2020 National Ethics Committee for the Protection of Human Beings Subject to Biomedical and Behavioral Research
Ethics Committee Address
Street address City Postal code Country
avenue Ruvubu Bujumbura 6807 Burundi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Activity limitation: ACTIVLIM stroke scale initial assessment, after intervention, after cross-over and at follow up
Secondary Outcome Impairments: • Balance: BBS (Berg Balance Scale) and TUG (Timed-Up and Go Test) • Global impairments: SIAS (Stroke impairments assessment Set) initial assessment, after intervention, after cross over and at follow Up
Secondary Outcome Functional autonomy: • Manual dexterity: BBT (Box and block test) • Manual ability: ABILHAND scale for stroke • Walking speed: 10mWT (10 meter Walk test) • Walking performances: 6MWT (6 minute Walk test) Baseline, after intervention, after crossover, at follow up
Secondary Outcome Participation : PM-scale (Participation Measurement scale) Baseline, after intervention, after crossover, at follow up
Secondary Outcome Quality of life: SS-QOL (Stroke specific Quality of Life scale) Baseline, after intervention, after crossover, at follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy and medical rehabilitation Department CHU ROI Khaled Boulevard du 28 Novembre Bujumbura 2210 Burundi
FUNDING SOURCES
Name of source Street address City Postal code Country
Wallonie Bruxelles International scholarship Place Sainctelette 2 Bruxelles 1080 Belgium
International Action Committee Universite Catholique de Louvain Rue des Wallons Louvain la neuve 1348 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UCLouvain Scholarships Rue des Wallons Louvain la Neuve 1348 Belgium University
Secondary Sponsor Wallonie Bruxelles International WBI scholarships Place Sainctelette Bruxelles 1080 Belgium Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Nduwimana Ildephonse Kinanira 3 Bujumbura Burundi
Bleyenheuft Yannick 53 Avenue Mounier Brussels 1200 Belgium
Thonnard Jean Louis 53 Avenue Mounier Bruxelles 1200 Belgium
Dr Alexis Sinzakaraye Avenue du 28 Novembre Bujumbura Burundi
Oyene Kossi Wansirou Parakou Benin
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Felix Nindorera nindorera.felix@gmail.com +25779362622 Avenue kigina
City Postal code Country Position/Affiliation
Bujumbura Burundi Physiotherapist and PhD student at Catholic University of Louvain
Role Name Email Phone Street address
Public Enquiries Ildephonse Nduwimana ilwimana@gmail.com +25779376031 kinanira 3
City Postal code Country Position/Affiliation
Bujumbura Burundi physiotherapist and PhD student at Catholic University of Louvain
Role Name Email Phone Street address
Scientific Enquiries Jean Louis Thonnard jean-louis.thonnard@uclouvain.be +32478278233 53 avenue mounier
City Postal code Country Position/Affiliation
Brussels 1200 Belgium Emeritus Professor at Catholic University of Louvain
Role Name Email Phone Street address
Scientific Enquiries Oyene Kossi oyene.kossi@gmail.com +22995016605 Parcelle I lot W64 Maison KOSSI
City Postal code Country Position/Affiliation
Parakou Benin Professor Researcher at National School of Public Health and Epidemiology Faculty of Medicine University of Parakou
Role Name Email Phone Street address
Public Enquiries Alexis SINZAKARAYE sinzalex@yahoo.fr +25779184008 Boulevard du 28 Novembre
City Postal code Country Position/Affiliation
Bujumbura Burundi Professor at Faculty of medecine National University of Burundi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As this trial is a single-blind study, the data collected will be coded by the assessor to hide the identities of patients (ID 1, 2 ...) and will be sent in an excel file to the principal investigator who will do statistical analyzes. All of the individual participant data collected during the trial after deidentification will be shared to anyone who wishes to access the data via a link created immediately after the publication. The data will be permanently accessible on the link Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be permanently accessible on the link. No end date Data collected during the trial will be shared to anyone who wishes to access the data especially researchers, peer review, rehabilitation clinicians. Data will include texts, tables, graphs, appendices...
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