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.: PACTR201602001333320 Date of Approval: 01/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title effect of a 12-week task oriented exercise training program on selected functional indices and quality of life of ambulant children with cerebral pals
Official scientific title effect of a 12-week task oriented exercise training program on selected functional indices and quality of life of ambulant children with cerebral palsy
Brief summary describing the background and objectives of the trial Background: Cerebral Palsy (CP) is the most common cause of physical disability in paediatric rehabilitation (Hielkema et al, 2010). Lower limb task-oriented training is one of the potential treatment options for walking disability in children with CP (Salem and Godwin, 2009). Studies that reported on task oriented training in children with CP train only balance function (Katz-Leurer et al, 2009; Kumban et al, 2010; Kim and Lee, 2013) and balance training alone may not always translate into the ability to perform complex functional mobility tasks. Research design: Randomized controlled trial. There will be random assignment and a control group. Method: The participants for this study will be children with ambulatory CP types aged between 4 and 12 years. They will be randomly assigned into either Group A, (Task oriented Exercise Training Program group [TETP]) or Group B, (Control Group) through balloting. Instruments: A biodata form, MobQues28 (ICC= 0.92, internal consistency ¿=0.99 (Roorda et al, 2010; Van Ravesteyn et al, 2010a), GMFM-66 (ICC = 0.99, inter-rater reliability r=0.97 (Russell et al, 2000; Shi et al, 2006) and CP QOL-Child version 2 (Internal consistency ¿ = 0.74-0.91 and test retest reliability ICC= 0.76-0.89 (Carlon et al. 2010). Procedure: After ethical approval is obtained, the study¿s procedure will be explained to prospective participants and their caregivers and after that, a written informed consent will be obtained from them prior to the intervention. The training group will perform task oriented training program (TETP) while the control group will perform conventional physiotherapy. Significance: The outcome of this research may encourage clinicians to use TETP in order to improve the functional capacity and quality of life of children with ambulatory CP types.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/12/2014
Actual trial start date 16/02/2015
Anticipated date of last follow up 28/02/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC/21/08/2008/AKTH/EC/1335 NHREC/05/01l2008a
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 Simple randomisation Sealed opaque envelopes Open-label(Masking Not Used) Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group task oriented exercise training program twice weekly 12 weeks individualized training program 23 Active-Treatment of Control Group
Control Group conventional physiotherapy twice weekly 12 weeks 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Children aged 4-12 years with diagnosis CP will be included (Because the CP-QOL child questionnaire is meant for children aged 4-12 years). ¿ Children with congenital and post-neonatally acquired CP due to meningitis, jaundice,and cerebral malaria would be included ¿ Only co-operative children with ability to follow simple instructions will be recruited ¿ Children with CP who have ability to walk independently or with walking aids (Gross Motor Function Classification System [GMFCS] levels I ¿ III) will be recruited ¿ Visual impairment ¿ Contractures and severe joint deformities ¿ Debilitating illness before or during the study ¿ caregiver not signing the consent form 4 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 09/02/2015 Aminu Kano Teaching hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
kano kano P.M.B. 3452 Nigeria
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 02/04/2015 UI/UCH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
ibadan Ibadan Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mobility, baseline 6 weeks 12 weeks 18 weeks(6 weeks follow up)
Primary Outcome motor function, baseline 6 weeks 12 weeks 18 weeks (6 weeks follow up)
Primary Outcome functional performance baseline 6 weeks 12 weeks 18 weeks (6 weeks follow up)
Secondary Outcome quality of life baseline 6 weeks 12 weeks 18 weeks (6 weeks follow up)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed Specialist hospital (MMSH) kano kano c/o P.M.B 3540 Nigeria
Aminu Kano Teaching Hospital Kano Kano P.M.B. 3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
TETFUND ABUJA ABUJA Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TETFUND ABUJA ABUJA Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Department of physiotherapy, college of medicine, University of Ibadan Ibadan Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Umaru Muhammad Badaru badaruum@gmail.com +2348035913759 kano
City Postal code Country Position/Affiliation
kano Nigeria Lecturer 1, Department of Physiotherapy, Bayero University, Kano
Role Name Email Phone Street address
Public Enquiries Omoyemi O. Ogwumike yemfide@yahoo.com +2348039218304 1 queen Elizabeth street
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Lecturer, Department of Physiotherapy, College of Medicine, University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Omoyemi O. Ogwumike yemfide@yahoo.com +2348039218304 Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Lecturer, Department of Physiotherapy, College of Medicine, University of Ibadan
REPORTING
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