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.: PACTR201609001709191 Date of Approval: 08/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating the impact of a two week intensive physiotherapy programme on the functional abilities of children aged six months to 13 years.
Official scientific title The impact of an intensive, daily two week programme of physiotherapy on the functioning of children with acquired brain injury: A randomised control trial.
Brief summary describing the background and objectives of the trial Background: Acquired brain injury ( ACBI) is a complex condition and children affected by it are a heterogeneous group posing challenges for rehabilitation therapists Forsyth [1]. In the Western Cape in South Africa there are two paediatric intermediate facilities catering for children with acquired brain injuries, but no standardised protocol is followed for rehabilitation service provision at the two facilities. Aim: The aim of this study is to evaluate the impact of a physiotherapy rehabilitation programme given within six months post the brain insult in children aged 6 months to 13 years with an acquired brain injury. The objectives of the study are to determine if there will be a significant difference in the change in gross motor function measure scores between children attending a two week daily physiotherapy programme pre- and post-intervention. Secondary objectives are to determine if the timing of the intervention is associated with the amount of change detected and if any functional improvement is maintained twelve weeks after the programme ends.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Acquired Brain Injury,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/05/2016
Actual trial start date 19/05/2016
Anticipated date of last follow up 15/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
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 Participants are randomly assigned to either immediate (Experimental group) or deferred (Control Group) intervention of two weeks of daily therapy by the draw of a card from an envelope by the caregiver. Stratified randomisation is used based on the Gross Motor Function Classification System. Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intensified physiotherapy input Daily Two weeks 45 minute daily physiotherapy session 26
Experimental Group Intensified physiotherapy input Daily Two weeks 45 minute to an hour daily physiotherapyand an hour of occupational and speech therapy where applicable to the child's functional needs. Participants also recieve input in group therapy twice per week. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Children who are within six months post injury onset with gross motor function classification levels (GMFCS) two to five (Appendix 5.5). ¿Parental or legal guardian consent that has been obtained. ¿Where possible the child¿s older than eleven years assent assisted by the legal guardian/ parent will be obtained. The child must be able to either read the consent form or be able to understand and respond to the content of the letter if it is read and explained to him or her. His/her comprehension will be tested by asking a few questions relating to the assent. The parent or caregivers opinion on the child¿s capacity will be taken into consideration when assessing the child¿s maturity to give assent. ¿The child who is medically stable and able to sustain at least 3 hours of therapy on a daily basis. ¿Previous therapy received will not result in exclusion. ¿ Rehabilitation patients already at SJH if their recovery is still within six months of their brain injury. Children with neurodegenerative conditions, cerebral palsy, disruptive behaviour and/or uncontrolled seizures exacerbated by movement, preventing the child from participating in therapy sessions. Any surgical intervention scheduled during the intervention period as it might impact on the amount of sessions that the child will receive during the study period. Children with progressive brain tumors, because the instability of the condition can influence the child¿s performance. Children with an associated fracture(s) preventing the child from participating in the programme will be excluded. 6 Month(s) 13 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 25/02/2016 University of Cape Town Faculty of Health Sciences Human Ethics Research Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Old Main Building, Grootte Schuur Hospital, Observatory, 7925 Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine if there will be a significant difference in the change in gross motor function measure scores between children attending a two week daily physiotherapy programme pre- and post-intervention. Pre intervention at baseline, Post 2 weeks intervention, 4 weeks post discharge and homebased therapy, 6 weeks post discharge, 12 weeks post discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St Joseph's Home for Chronically Ill Children Pallotti Road, Montana Cape Town 7490 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Cape Town , Faculty of Health Sciences, Physiotherapy Department Faculty of Health Sciences F45 Old Main Building Groote Schuur Hospital Observatory 7925 Cape Town 8000 South Africa
Faiza Achmat Pallotti Road, Montana Cape Town 8000 South Africa
University of Cape Town , Faculty of Health Sciences, Physiotherapy Department Faculty of Health Sciences F45 Old Main Building Groote Schuur Hospital Observatory 7925 Cape Town 8000 South Africa
Faiza Achmat Pallotti Road, Montana Cape Town 8000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faiza Achmat Hospital
COLLABORATORS
Name Street address City Postal code Country
Proff. Jennifer Jelsma Faculty of Health Sciences F45 Old Main Building Groote Schuur Hospital Observatory 7925 Cape Town 8000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faiza Achmat faiza.achmat@gmail.com 0219340352 Pallotti Road, Montana,
City Postal code Country Position/Affiliation
Cape Town 7490 South Africa Therapy Manager
Role Name Email Phone Street address
Public Enquiries Jennifer Jelsma jennifer.jelsma@uct.ac.za 0214066401 Faculty of Health Sciences F45 Old Main Building Groote Schuur Hospital Observatory 7925
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Head of Post Graduate Education
Role Name Email Phone Street address
Scientific Enquiries Marc Blockman faiza.achmat@gmail.com 0027(21) 4066492 Faculty of Health Sciences at the University Of Cape Town, Old Main Building Groote Schuur Hospital, Floor E52, Room 23, Observatory, 7925.
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Chair: The Research and Ethical Committee,
REPORTING
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