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.: PACTR202307516307701 Date of Approval: 27/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of a 10-week WalkWithMe application program on walking-related physical activity levels among community dwelling stroke survivors: a randomized controlled trial in Benin.
Official scientific title Effects of a 10-week WalkWithMe application program on walking-related physical activity levels among community dwelling stroke survivors: a randomized controlled trial in Benin.
Brief summary describing the background and objectives of the trial Background: PA after stroke can be increased by using mobile health (mHealth) applications (Rintala et al., 2022). The walking time and number of steps per day of stroke survivors can be significantly improved by applying a mobile, home-based intervention (Grau-Pellicer, Lalanza, Jovell-Fernández, & Capdevila, 2020; Paul et al., 2016). In this way, a mHealth application can be a successful approach to increase access to health care in low- and middle-income countries (Hurt, Walker, Campbell, & Egede, 2016). Objective: to evaluate the effect of the WalkWithMe application program on walking-related physical activity levels in chronic stroke survivors in Benin.
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 16/07/2023
Actual trial start date
Anticipated date of last follow up 16/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WalkWithMe Walking at least two times per week with a duration depending on their personal target goal that correspond to the end-goal. The start duration corresponds to the end goal minus 45 minutes with a minimum start duration of 10 minutes uninterrupted walking. 10 Weeks It will be a remotely supervised individualized training which consist in walking in one’s community, based on goal setting with personal training schedule. Participants had to walk independently in their own community for 10 weeks. After baseline assessment, the participant and physiotherapist will determine an individual end goal of at least 30 minutes of walking. A built-in protocol in the application will establish a weekly schedule based on the end goal of the participant. More details on the procedure can be found in the WWM user protocol (which will be available). A WhatsApp group will be created with the participants and the researcher to contact each other in case of problems during the intervention. Also, weekly motivation will be given by the physiotherapist using the WhatsApp group and the participants will be encouraged to stimulate each other by sending screenshots of their walking activities and to facilitate especially non-written communication between all. Moreover, participants will receive two weekly notifications from the WWM app to stimulate adherence to the walking program. Thus a weekly coaching to motivate participants will be establish. Very specific exchanges will be conducted with each of the participants in order to change their behavior towards the practice of physical activity. 27
Control Group No care 10 weeks While waiting to cross over to WWM app program, participants do not participate in any physical therapy which will not involve energy expenditure. We will check in with them weekly via WhatsApp and they will also have a notebook to document their activities. 27 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic stage of adults stroke at least 6 months after stroke onset Absence of cognitive impairment and dementia Ability to walk independently or with assistive devise, outside home during at least 10 min with gait velocity vary from 24 m/min (0.4m/s) to 79 m/min (1.3m/s), based on community ambulation measures Not undergoing any form of rehabilitation or other physical treatment at intervention period; Ability of the patient or a family caregiver to use modern technology. Contraindication to physical exercise; Other permanent or progressive neurological pathologies interfering walking such as hip prosthesis, rheumatoid arthritis. Adult: 19 Year-44 Year,Aged: 65+ 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 20/03/2023 Comite Local d Ethique pour la Recherche Biomedicale
Ethics Committee Address
Street address City Postal code Country
Universite de Parakou Parakou BP 123 Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome walking-related physical activity levels measured with physical activity sensors and walking domain of self-reported scale. Participants will wear the sensors the first and last week and the IPAQ will be administrated pre and post intervention to measure their level of physical activity.
Secondary Outcome First, the walking endurance measured by 6MWT, second, the locomotor skill will be evaluated by ABILOCO-Benin and third, the Stroke Specific Quality of Life Scale will be executed to evaluate self-reported health-related quality of life Secondary clinical outcome measures will be executed pre- and post-intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physical therapy center of University Hospital at Parakou. Parakou Parakou BP 02 Benin
FUNDING SOURCES
Name of source Street address City Postal code Country
BOF Universiteit Hasselt - Campus Hasselt Martelarenlaan 42 Hasselt B-3500 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NA NA NA Benin Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NOUKPO INES ines.noukpo@uhasselt.be 0022995344508 Parakou
City Postal code Country Position/Affiliation
Parakou Benin PhD Student at REVAL Rehabilitation Research center
Role Name Email Phone Street address
Public Enquiries OYENE KOSSI oyene.kossi@uhasselt.be 0022995016605 Parakou
City Postal code Country Position/Affiliation
Parakou Benin Assistant Professor of University of Parakou Benin
Role Name Email Phone Street address
Scientific Enquiries Peter Feys peter.feys@uhasselt.be 0032486744409 Hasselt
City Postal code Country Position/Affiliation
Hasselt Belgium Professor of REVAL Rehabilitation Research center at UHasselt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants will sign a consent form before starting this study and will be free to withdraw at any time. Data obtained through this study may be provided to qualified researchers with academic interest in stroke. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 10 MONTHS STROKE
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