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.: PACTR201911806294013 Date of Approval: 06/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Biofeedback Training Following Semitendinosus Release in Spastic Quadriplegic Cerebral Palsied Children
Official scientific title Biofeedback Training Following Semitendinosus Release in Spastic Quadriplegic Cerebral Palsied Children
Brief summary describing the background and objectives of the trial Background and purpose: Shortening in medial hamstring is one of the most common complications in spastic quadriplegic cerebral palsy. Objective: The present study was conducted to determine the effect of EMG biofeedback stimulation during two weeks immobilization period after tendon-release in spastic quadriplegic cerebral palsied children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Spasticity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/09/2019
Actual trial start date 30/09/2019
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date 31/10/2019
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
Parallel: different groups receive different interventions at same time during study 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 EMG biofeedback stimulation after removal of plaster cast 30min two weeks Group A (control) received EMG biofeedback stimulation after removal of plaster cast for 15 Active-Treatment of Control Group
Experimental Group Received EMG biofeedback stimulation during immobilization period plus program of control 30 min 2 weeks group B (study) received EMG biofeedback stimulation during immobilization period (two weeks) in addition to the same program given to control. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age: 7-9 years old.• Gender: male and female. • Gender: male and female. • They were operated by medial hamstring lengthening (semitendinosus) • Children age exceeding 9 years old or less than 7 years in not included in the study. • Any other orthopedically deformity or neurological problems. • Other syndromes causing the same tightness are excluded. Child: 6 Year-12 Year 7 Year(s) 9 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 29/09/2019 Faculty of Physical Therapy Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 El Zayat giza 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Improving knee extension peak torque. 2. Improving knee excursion 2-3 weeks
Secondary Outcome 1. Improved knee functions and improved prognosis and rehabilitation. 3-4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo university 7 El Zayat Giza 0003 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa Saeid Abdulrahman 21 Sheikh Zayed Giza 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy 7 El Zayat Giza 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Khaled Ahmed Olama 5th settlements Cairo 0002 Egypt
Heba Ali El Bahy 1st settlement Cairo 0002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa Mahmoud radwakku@gmail.com 00201027713662 7 El Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Lecturer in department of physical therapy in pediatrics
Role Name Email Phone Street address
Public Enquiries khaled Olama k_olama@hotmail.com 00201110222235 5th settlement
City Postal code Country Position/Affiliation
Cairo 0002 Egypt professor in department of physical therapy in pediatrics
Role Name Email Phone Street address
Scientific Enquiries hala kassem halakassem146@gmail.com 00201143686666 5th settlement
City Postal code Country Position/Affiliation
Cairo 0002 Egypt professor of physical therapy in pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes here by we the participants and with patient consent to share the results of our study soon it is published Informed Consent Form,Statistical Analysis Plan within 12 month time frame controlled through a third party
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable No
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