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.: PACTR201907519544271 Date of Approval: 24/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative efficacy of water-based and land-based exercises on spasticity and gross motor function in children with cerebral palsy
Official scientific title Comparative efficacy of water-based and land-based exercises on spasticity and gross motor function in children with cerebral palsy
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) is the most common motor disability in childhood and it is associated with lifelong motor impairments (Aisen et al, 2011). It is a disabling condition that affects a child¿s life and that of his/her family irreversibly, usually it is a non-progressive condition but improvement over time is challenge (Abi-Chahine, 2016). Cerebral palsy is a common neurologic problem in children and is reported as occurring in approximately 2-2.5 of 1000 live births globally (Shevell et al, 2013). Reports by El Tallawy et al (2011) also showed a prevalence of 2 per 1000 births in Africa. In Nigeria, CP is the second most common disorder seen at the paediatric neurology clinics after epilepsy (Lagunju and Okafor, 2009; Adekoje et al, 2016). Majority (75%) of children with cerebral palsy suffer from the spastic form (Dimitrijevic et al, 2012; Adekoje et al, 2016).Spasticity has been implicated as a major hindrance to development of motor skills and functional performance in children with cerebral palsy (CP). Properly-structured exercises either on land or in water have been reported to be efficacious in ameliorating spasticity and improving functional performance in children with CP. This study therefore compared the efficacy of water-based and land-based exercises on spasticity and gross motor function in children with CP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cerebral Palsy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 06/06/2017
Actual trial start date 13/06/2017
Anticipated date of last follow up 20/08/2017
Actual Last follow-up date 27/08/2017
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
ADM/DCST/HREC/APP/1525
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 computer generated random number sequence determined by 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 water-based exercises 1 hour 40 minutes, twice a week 10 weeks 4 stages of exercises carried out in water 15
Control Group Landbased exercises 1 hour 40 minutes 10 weeks 4 stages of exercises same as the experimental group 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Who were diagnosed of the spastic type Not older than 12 years of age Children with associated neurodevelopmental conditions were excluded from this study. 1 Year(s) 12 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 08/05/2017 Health Research and Ethics Committee of the Lagos University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Idi Araba Lagos Lagos 100001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Modified Ashworth scale for spasticity Baseline 4 weeks 8 weeks 10 weeks
Secondary Outcome There was secondary improvement in basic ADLs and gait performance by ambulatory subjects After 10 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Childrens Developmental Centre Surulere Lagos 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Newtontherapy consults Surulere Lagos 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Lagos Akoka Lagos 234 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Codas NeuroRehab Hospital Bode Thomas, Surulere Lagos 234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caleb Gbiri calebgbiri@yahoo.com 2348033598072 Idi Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Senior Lecturer/ University of Lagos
Role Name Email Phone Street address
Public Enquiries Caleb Gbiri calebgbiri@yahoo.com 2348033598072 Idi Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Senior Lecturer/ University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Caleb Gbiri calebgbiri@yahoo.com 2348033598072 Idi Araba
City Postal code Country Position/Affiliation
Lagos 234 Nigeria Senior Lecturer/ University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data of included participants Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months follow link
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 1. Both water-based and land-based exercises are veritable tools and either can be used in the management of spasticity in children with cerebral palsy. 2. Water-based exercises are more beneficial in the improvement of gross motor function in children with spastic cerebral palsy. 12/07/2019 25/06/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://journals.sagepub.com/doi/full/10.1177/2333794X19857378
Changes to trial information