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.: PACTR201311000634685 Date of Approval: 27/08/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of Therapeutic Electrical Stimulation on abdominal muscle strength and gross motor function in children with cerebral palsy
Official scientific title The effect of Therapeutic Electrical Stimulation on abdominal muscle strength and gross motor function in children with cerebral palsy: a randomised control trial
Brief summary describing the background and objectives of the trial While spasticity has long been considered the primary impairment in children with CP,the presence of weakness associated is gaining increasing recognition and importance and the coexistence of the two impairments may result in greater participation restriction for the individual.The use of electrical stimulation in the treatment of children with CP is being increasingly investigated as the potential to improve strength and motor function exists.This study strives to determine its effects on GMF
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cerebral Palsy,Musculoskeletal Diseases,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 21/01/2013
Actual trial start date 21/01/2013
Anticipated date of last follow up 14/03/2013
Actual Last follow-up date 14/03/2013
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 47
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised The researcher and the three other therapists working at the Institution discussed each of the study participants coming to a consensus regarding a GMFCS level allocation for each. Participants were then stratified into their relevant GMFCS levels and names were placed into five envelopes representing each level on the score. The first name drawn from each envelope was allocated to the control group and the second to the intervention group and so on until each participant was allocated. Names were placed in white envelopes and another person not involved in the study picked names out of each envelope as explained above. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control Group-Conventional physiotherapy The control group continued to receive their usual physiotherapy weekly or biweekly intervention (including Neurodevelopmental therapy, gait training, strengthening etc) 30-45 minutes per session The control group continued to receive their usual physiotherapy weekly or biweekly intervention (including Neurodevelopmental therapy, gait training, strengthening etc) 25 Active-Treatment of Control Group
Experimental Group Experimental Group The experimental group continued to receive their 45 min weekly or biweekly therapy sessions during which they used the TES for 20 mins. They received an additional 2 passive 20 min TES sessions each 20 mins x 4 See dose for description 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Aged 5-18 years - Diagnosed by a medical practitioner as having cerebral palsy - Uncontrolled epilepsy - Surgical or other medical intervention expected during the proposed intervention time or up to three months prior to the trial - Participant unable to give clear voluntary assent and/or no written consent given by parent or guardian 5 Year(s) 18 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 26/06/2012 Faculty of Health Sciences Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Groote Schuur Hospital old Main Building, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gross Motor Function Measure-66 Pre and post intervention
Primary Outcome Timed Sit ups in one minute Pre and post intervention
Secondary Outcome Peak Flow Readings Pre and post intervention
Secondary Outcome Timed Up and Go Pre and post intervention
Secondary Outcome Pediatric Quality of Life Measure Pre and post intervention
Secondary Outcome Pediatric Reach Test Pre and post intervention
Secondary Outcome Participant evaluation form Post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Hope School Pallinghurst Road Johannesburg 2197 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
1. UCT Physiotherapy Department Room E52-24 Groote Schuur Hospital old Main Building, Observatory, Cape Town 7925 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Privately funded by researcher Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Jessica Joffe-Primary researcher
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jessica Joffe jessicajoffe@hotmail.com +27116466130 Pallinghurst Road
City Postal code Country Position/Affiliation
Johannesburg 2197 South Africa Physiotherapist
Role Name Email Phone Street address
Public Enquiries Jessica Joffe jessicajoffe@hotmail.com 27116466130 Pallinghurst Road
City Postal code Country Position/Affiliation
Johannesburg 2197 South Africa Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Jessica Joffe jessicajoffe@hotmail.com 27116466130 Pallinghurst Road
City Postal code Country Position/Affiliation
Johannesburg 2197 South Africa Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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