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.: PACTR201911720095534 Date of Approval: 19/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Topical Anesthesia Versus Hand Weight Bearing on Modulating Upper Limb Spasticity in Children with Hemiplegia (A double blind study)
Official scientific title Topical Anesthesia Versus Hand Weight Bearing on Modulating Upper Limb Spasticity in Children with Hemiplegia (A double blind study)
Brief summary describing the background and objectives of the trial Background and purpose. This study was conducted to compare between the effect of topical anesthesia and hand weight bearing on controlling upper limb spasticity in hemiplegic cerebral palsied children
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 Early detection /Screening
Anticipated trial start date 01/09/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 02/11/2019
Actual Last follow-up date 04/11/2019
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I received topical anesthesia which was applied for few seconds on the affected upper limb 30min 3 month Group I received topical anesthesia which was applied for few seconds on the affected upper limb and maintained for 30 minutes followed by a designed exercise program 15 Active-Treatment of Control Group
Experimental Group group II received weight bearing on the affected hand with the limb maintained in extension diagonal 30 min 3 months group II received weight bearing on the affected hand with the limb maintained in extension diagonal 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• The degree of spasticity ranged from 1+ to 2 grades according to the modified Ashowrth scale. (15) • The affected upper limb was free from any structural deformities; however, patients demonstrated variable degree of tightness. • They had partial volitional control over the antispastic muscle groups. • They had normal superficial skin sensations of the affected upper limb. • All of them were able to understand verbal command • Other diagnosis as delayed milestones, genetic disorders, metabolic disorders and brain tumors. • Any previous history of orthopedic injuries, • Any history of botulinum toxins infusion in spastic muscles of the affected upper extremity. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 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 03/11/2019 Faculty of Physical Therapy Ethical Committee
Ethics Committee Address
Street address City Postal code Country
El Zayat Giza 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measuring the effect of both treatment programon spasticity of upper limb 3 months
Secondary Outcome Comparing between both lines of treatment and recommending which is best for treating spasticity. 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo university El zayat Giza 0003 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Heba Ali Bahey El Zayal Giza 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical Therapy Cairo University El Zayat Giza 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hala Ibrahim Kasem El zayat Giza 0003 Egypt
Khaled Ahmed Olama El Zayat Giza 0003 Egypt
Radwa Saeid Abdulrahman El Zayat Giza 0003 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba Bahey heba_bahey@yahoo.com 0020115592552 El Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Professor in Department of Physical Therapy El Jouf University kingdom of Saudi Arabia
Role Name Email Phone Street address
Public Enquiries Radwa Abdulrahman radwakku@gmail.com 00201027713662 El Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Lecturer in Department of Physical Therapy for Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Khaled Olama k_olama@hotmail.com 00201110222235 El Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Professor in Department of Physical Therapy for Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes here by we the research principal investigators and collaborators along with patients agree to share Participants data. Statistical Analysis Plan 12 months A third party person will control the sharing and review proper documents qualifications and requests
URL Results Available Results Summary Result Posting Date First Journal Publication Date
DOI: https://doi.org/10.37506/ijphrd.v12i1.13862 Yes 30/01/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/01/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information