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.: PACTR201801002940240 Date of Approval: 03/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Autogenic versus reciprocal inhibition
Official scientific title Autogenic inhibition versus reciprocal inhibition techniques on spastic children
Brief summary describing the background and objectives of the trial Studying the result of autogenic inhibition versus reciprocal inhibition techniques on the children spasticity is a strategy for determining which of them is the most actual in reducing spasticity. Objective: To investigate the efficacy of autogenic inhibition versus reciprocal inhibition on hemiplegic children spasticity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,spasticity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 16/01/2017
Actual trial start date 30/01/2017
Anticipated date of last follow up 02/10/2017
Actual Last follow-up date 05/10/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group autogenetic inhibition maximum isometric muscle contraction (MIC) hold for 6 seconds and then relax for 6 seconds for the agonist muscle repeated 5 times maximum isometric muscle contraction (MIC) hold for 6 seconds and then relax for 6 seconds for the agonist muscle 20
Experimental Group reciprocal inhibition technique maximum isometric muscle contraction (MIC) hold for 6 seconds and then relax for 6 seconds for the antagonist muscles repeated 5 times maximum isometric muscle contraction (MIC) hold for 6 seconds and then relax for 6 seconds for the antagonist muscles 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Forty spastic hemiplegic CP children of both sexes. ages were ranged from 7 to 9 years. They had grade 1 or 1+ according to modified Ashworth scale and grade II or III according to Manual Ability Classification Scale (MACS). they can understand and follow verbal commands and instructions included in the test. More than grade 1 or 1+ according to modified Ashworth scale more than grade II or III according to Manual Ability Classification Scale (MACS) 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 10/01/2017 faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed elziat st bein srayat Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome EMG in form of H\M ratio immediately after intervention and after 2min post-intervention on the spastic side of each child.
Primary Outcome Muscle Functional Magnetic Resonance Imaging MRI-images were obtained under 2 consecutive conditions 1] at rest (T2- rest) after 30min of supine lying, 2] immediately following exercise to avoid regain the resting metabolic condition of the muscles.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo university 7 Ahmed elziat st bein srayat Giza 11311 Egypt
faculty of medicine ain shams university Abasia square cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 77 shalhoub st ahmed essmat ain shams Cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7 Ahmed elziat st bein srayat Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Serag Eldein Mahgoub Mohamed Mostafa 77 shalhoub st ahmed essmat ain shams Cairo 11311 Egypt
Mohamed Ali Elshafey Shahin street dakadous meet ghamr Dakahlia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub st ahmed essmat ain shams, 8130 eldobat district fisaliah najran Saudi Arabi
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Assistant professor Basic Sciences department -Faculty of Physical Therapy¿ Cairo University.
Role Name Email Phone Street address
Public Enquiries Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub st ahmed essmat ain shams, 8130 eldobat district fisaliah najran Saudi Arabi
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Assistant professor Basic Sciences department -Faculty of Physical Therapy¿ Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub st ahmed essmat ain shams,
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Assistant professor Basic Sciences department -Faculty of Physical Therapy¿ Cairo University.
REPORTING
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Changes to trial information