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.: PACTR201803003100338 Date of Approval: 16/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title new approach gamal technique bladder rehabilitation spinal cord injury
Official scientific title effect of electromyography exercises of the abdominal contractions on bladder emptying of the paraplegic spinal cord injury patients
Brief summary describing the background and objectives of the trial Spinal cord injury (SCI) is a difficult and serious problem. It is estimated that 15,000 SCIs occur in the United States each year (West et. al, 1999).Urinary tract diseases are one of the primary causes of death in spinal cord injury patients (Frankel et. al, 1998), Bladder management methods included indwelling catheterization, clean intermittent catheterization (CIC) , condom drainage , suprapubic cystostomy, reflex voiding and normal voiding .indwelling catheterization was found to be the highest percentage in urinary tract infections and other complications while normal voiding was found to result in the least percentage of infections(Singh et. al, 2011).This new approach was designed to make a safe and easy way for emptying the bladder of the paraplegic spinal cord injury patients without using the catheterization as the main causes of urinary tract infections are the inability to empty the bladder in a proper way and the irritation of the catheter.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied bladder function spinal cord injury,Injury, Occupational Diseases, Poisoning,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/02/2018
Actual trial start date 02/02/2018
Anticipated date of last follow up 10/02/2018
Actual Last follow-up date 10/02/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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 randomisation Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group the new technique plus the medical intervention the new technique twice daily plus home ecercises and the medical intervention daily 6 weeks two treatment sessions per week by the emg biofeedback , home program by these exercises and medical intervention by antibiotics after urine culture 20
Control Group medical intervention only daily 6 weeks urine culture and suitable antibiotic 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- All patients suffer from spinal cord injury in the form of paraplegia with age ranging from 20 to 40 years old 2- Medically stable cases specially after the spinal fixation till approved by the physician to participate. 1- Medically unstable conditions 2- Patients using suprapubic catheterization 3- Mentally disturbed patients 4- Decreased awareness and patients in a coma 20 Year(s) 40 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 01/02/2018 ethical committee faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
faculty of physical therapy ahmed el zayat street giza Egypt
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 27/01/2018 dar el mona
Ethics Committee Address
Street address City Postal code Country
kilo 10.5 cairo alex road giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome residual urine volume 1-at the begining of the treatment program 2-at the end of the treatment program
Secondary Outcome 1- spinal cord independence measure(SCIM) 1- at the begining of the treatment 2- at the end of the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
dar el mona physical therapy and rehabilitation resort kilo 20.5 cairo alex road giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
dar el mona physical therapy and rehabilitation resort kilo 20.5 cairo alex road giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mohamed gamal hassan 7 sayed el bahnasawe street el nakheel street el haram giza giza Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
dar el mona physical therapy and rehabilitation resort kilo 20.5 cairo alex road giza Egypt
mohamed gamal hassan 7 sayed el nahnasawe street nakhel street el haram giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed gamal hassan mohamedgamal_pt@yahoo.com 201005285747 7 sayed el bahnasawe street el nakheel street el haram
City Postal code Country Position/Affiliation
giza Egypt lecturer assisstant and senior physiotherapist
Role Name Email Phone Street address
Public Enquiries mohamed gamal hassan mohamedgamal_pt@yahoo.com 201005285747 7 sayed el bahnasawe street el nakheel street haram
City Postal code Country Position/Affiliation
giza Egypt
Role Name Email Phone Street address
Scientific Enquiries mohamed gamal hassan mohamedgamal_pt@yahoo.com 201005285747 7 sayed el bahnasawe street el nakheel street haram
City Postal code Country Position/Affiliation
giza Egypt
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