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.: PACTR202011738099314 Date of Approval: 20/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Akwenda Cerebral Palsy Intervention Program
Official scientific title Community Based Intervention Programme for Children with Cerebral Palsy in a Low-Resource Setting in Sub-Saharan Africa
Brief summary describing the background and objectives of the trial Cerebral palsy (CP), the most common childhood-onset motor disorder, is often accompanied by associated impairments making it a complex condition placing a heavy burden on families and health systems. Most children with CP live in low- and middle-income countries (LMIC) with little access to rehabilitation professionals. This study aims to evaluate the feasibility of a multi-dimensional intervention programme and its impact on caregivers, children and communities. The intervention is based on the ICF framework, evidence based best practice and WHO’s universal health coverage and access. Key to the intervention is a series of parent-led training workshops.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2021
Actual trial start date
Anticipated date of last follow up 01/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants)
Recruitment status 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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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
Experimental Group Akwenda Cerebral Palsy Intervention Program Weekly interventions with several different components according to the specific Akwenda programme schedule 1 Year Multi-component, community-based, family-oriented intervention 44
Control Group No Intervention As per their usual facility therapy appointments 1 Year The usual care 44 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children and youth with confirmed CP who now are 7-22 year old They were identified in a screening survey carried out at IM-HDSS in 2015 when they were 2-17 year. In addition we will recruit 20 younger children who now are 2-7 years with CP. This will be done by community development officer. These children are living in the IM-HDSS but were not included in the initial prevalence study since they were less than 2 years. The CP diagnosis is determined by using the SCPE flow chart. Children who are already receiving similar treatment services like that to be offered in the Akwenda programme. Children from the original cohort who are deceased or have moved to new locations away from the study area. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 23 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 01/10/2020 Makerere University College of Health Sciences. School of Public Health. Higher Degree Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere University Kampala 7072 Uganda
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 28/01/2020 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
plot 6kimera road-Ntinda Kampala 6884 Uganda
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 11/12/2019 Makerere University College of Health Sciences. School of Public Health. Higher Degree Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere University Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child outcome measures - Change in gross motor function measures. Tool - Gross Motor Function Measure 66 1 and 2 years, respectively
Primary Outcome Child outcome measures - A parent-reported measure of the child’s independence in self-care, mobility and social function. Tool - Uganda version of Pediatric Evaluation of Disability Inventory. 1 and 2 years, respectively
Primary Outcome Child outcome measure - Participation, attendance and involvement. Tool - Picture My Participation 1 and 2 years, respectively
Primary Outcome Child outcome measure- Use of Technical Assistive Devices. Tool - Technical Assistive Device questionnaire. 1 and 2 years, respectively
Secondary Outcome Child outcome measures - The level of attainment. Tool - Goal settings; achievement of goals. 1 and 2 years, respectively
Primary Outcome Caregiver related outcomes - Attitude, knowledge and skills. Tool - Caregiver knowledge and understanding questionnaire. 1 and 2 year, respectively
Primary Outcome Caregiver related outcome - Caregiver skill and behaviours. Tool - Caregiver video analysis assessment. 1 and 2 years, respectively
Primary Outcome Caregiver related outcome - Quality of life. Tool - 36 item Pediatric Quality of Life Inventory Family Impact Module. 1 and 2 years, respectively
Primary Outcome Caregiver related outcome - Stress. Tool - Zimbabwe Caregiver Challenges Scale 1 and 2 years, respectively
Primary Outcome Community-related outcomes - Knowledge, attitudes, and practices. Tool - Communication and Advocacy Survey Questionnaire 1 and 2 years, respectively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Iganga Mayuge Health District Surveillance System Community Makerere University Kampala 7072 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
The Swedish Research Council Vastra Jarnvagsgatan 3 Stockholm Box 1035 Sweden
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hans Forssberg Karolinska Institutet Astrid Lindgren Childrens Hospital Stockholm 17176 Sweden University
Secondary Sponsor Angelina Kakooza Makerere University Makerere University Kampala 7072 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Hans Forssberg Karolinska Institutet Astrid Lindgren Children Hospital Stockholm 17176 Sweden
Angelina Kakooza Mwesige Makerere University Department of Paediatric and Child Health - School of Medicine Kampala 7072 Uganda
Gillian Saloojee 12A Rhodes Ave, Parktown Johannesburg 2193 South Africa
Carin Andrews Karolinska Institutet Astrid Lindgren Children Hospital Stockholm 17176 Sweden
Diane Damiano National Institute of Health Bethesda MD 20892 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Angelina Kakooza Mwesige angelina_kakooza@yahoo.co.uk +256772499583 Makerere University Department of Paediatric and Child Health, School of Medicine.
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Senior Lecturer Makerere University
Role Name Email Phone Street address
Public Enquiries Elizabeth Asige asigelizabeth@yahoo.com +256772394159 Makerere University
City Postal code Country Position/Affiliation
Kampala 242 Uganda PhD Student Makerere University
Role Name Email Phone Street address
Scientific Enquiries Hans Forssberg hans.forssberg@ki.se +46708730830 Astrid Lindgren Children Hospital
City Postal code Country Position/Affiliation
Stockholm 17176 Sweden Collaborator Karolinska Institutet
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that support the findings of this study will be made openly available at the Swedish National Data Service https://snd.gu.se/en/about-us. We will later update this PACTR register with http://doi.org/[doi] and reference number. Informed Consent Form,Study Protocol 1 Year Children and youth Community based intervention Parent-led
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