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.: PACTR201703002114301 Date of Approval: 19/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lidocaine iontophoresis combined with exercises for children with spastic hemiplegic cerebral palsy
Official scientific title Lidocaine Iontophoresis Combined with Exercise Intervention on Gait and Spasticity in Children with Spastic Hemiplegic Cerebral Palsy
Brief summary describing the background and objectives of the trial Lidocaine iontophoresis has the potential to reduce muscle tone. Combining lidocaine iontophoresis intervention with standard rehabilitation may offer greater benefits than standard rehabilitation only. Reduction of muscle spasticity followed immediately by therapeutic intervention may help to increase range of motion and allow the child to work on treatment activities and learn functional skills such as walking without interference of spasticity. The purpose of this study was to evaluate the effectiveness of lidocaine iontophoresis administered immediately before exercises, as an adjunct to standard rehabilitation. We hypothesized that lidocaine iontophoresis would improve gait, reduce muscle spasticity and result in better outcomes when compared to standard rehabilitation in children with spastic hemiplegic cerebral palsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cerebral Palsy,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/03/2013
Actual trial start date 01/03/2013
Anticipated date of last follow up 01/03/2014
Actual Last follow-up date 01/03/2014
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
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 Children were systematically randomized using sealed envelopes. Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exercises and lidocaine iontophoresis three times per week three months Children in the experimental group received 2% lidocaine epinephrine followed by exercise interventions targeted the development of gross motor skills such as balance and walking 15 Uncontrolled
Control Group Exercise intervention three times per week three months Children in the control group received exercise intervention similar to exercises given to the intervention group targeted the development of gross motor skills such as balance and walking 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) A clinical diagnosis of spastic hemiplegic cerebral palsy; 2) degree of spasticity ranged from mild to moderate for the affected lower limb according to the Oswestry scale 3) ability to walk without support; 4) absence of contractures of deformities in the lower extremities; 5) no previous surgery or Botox injection in the last six months prior to participation in the study; and 6) ability to follow instructions 1) medical diagnosis/genetic disorder in addition to cerebral palsy; 2) a diagnosis of autism; 3) attention deficit disorders; 4) Botox injection in the past 6 months prior to participation in the study; 5) fixed ankle contractures; 6) orthopedic surgery in the past 6 months prior to participation in the study; 7) uncontrolled seizures; and 8) inability to follow instructions. 4 Year(s) 6 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 07/01/2013 Reserach Ethics Committee, Faculty of Physiotherapy, Cairo University.
Ethics Committee Address
Street address City Postal code Country
Faculty of Physiotherapy Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcomes were gait parameters and spasticity. Gait was assessed using Qualisys motion capture system and surface electromyography was used to assess muscle tone using Hoffman reflex/Myogenic (H/M) response ratio of the soleus muscle. One week before and one week after the intervention.
Primary Outcome Temporal and Spatial Gait Parameters One week before and one week after the intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the Physical Therapy Faculty Clinic, Cairo University Faculty of Physiotherapy Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physiotherapy Cairo university Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma Hegazy Faculty of Physiotherapy Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma Hegazy fhegazy@sharjah.ac.ae 971504800753 Faculty of Physiotherapy, Cairo University
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor, Faculty of Phisotherapy
Role Name Email Phone Street address
Public Enquiries Ibrahim Moustafa ibrahiem.mostafa@pt.cu.edu.eg 00201227022334 Faculty of Physiotherapy, Cairo University
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor/Faculty of Physiotherapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Dalia Mosaad drdaliamosaad@gmail.com 00201001469096 Faculty of Physiotherapy, Cairo University
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor/Faculty of Physiotherapy, Cairo University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information