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.: PACTR201703001849291 Date of Registration: 04/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Hydrotherapy on Performance in Children with Brain Tumor
Official scientific title Effect of Hydrotherapy on Performance in Children with Brain Tumor
Brief summary describing the background and objectives of the trial Background: Brain and spinal cord tumors are the second most common cancers in children after leukemia. They account for about 1 out of 4 childhood cancers. More than 4,000 central nervous system tumors are diagnosed each year in children and teens. It has been reported that those children have easy fatigability. Objectives: This study was conducted to investigate the effectiveness of pool therapy on muscle strength, quality of life and cardiovascular fitness in Children with brain tumor.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2016
Actual trial start date 01/12/2016
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 31/03/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Land Exercises Only 3 sessions per week 3 months This group will receive a land-exercise program. The program will take 30 minutes (5 minutes each with 1 minute rest in between). ¿ Mode of exercise : Mild to moderate aerobic training according to the child¿s ability ¿ Repetition: At least 10 rep. for 2 sets. ¿ Frequency: 3 sessions per week. ¿ Total duration program: 3 months. 25
Experimental Group Land Exercises + Hydrotherapy 3 sessions per week 3 months The selected program will be in the form of: 1. Sitting while strengthening shoulder horizontal adductors by using weights. 2. Sitting while pushing down by using weights. 3. Sitting while strengthening elbow extensors by using weights. 4. Sitting while holding weights for a while. 5. Standing on uneven surface. 6. Pushing downs by legs. 7. Sitting balance. 8. Sitting with pushing by hands 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
They will be selected according to the following criteria: 1. Children between 5-12 years old. 2. Children with affection of motor function. 3. Children with muscle weakness. 4. Time elapsed since the start of treatment >1 month. Children who have one or more of the following criteria will be excluded from the study: 1. Children who cannot follow orders or instructions. 2. Children with a genetic disorder or mental retardation. 3. Children with a chronic lung disease. 4. Sever cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest). 5. Children with a neuromuscular disease not related to tumor. 6. Children with zero muscle power. 5 Year(s) 12 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 23/10/2016 Ethics committee, Faculty of Physical Therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432 Cairo +02 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 12/10/2016 Institution Review Board (IRB)
Ethics Committee Address
Street address City Postal code Country
Washington DC Washington DC + United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Muscle endurance/strength Pre-treatment After 6 weeks of treatment Post-treatment
Secondary Outcome Quality of life(Child report + Parent report) Pre-treatment After 6 weeks of treatment Post-treatment
Secondary Outcome Cardiorespiratory fitness(The Six-minute walk test + The timed up-and-down stairs test) Pre-treatment After 6 weeks of treatment Post-treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Children's Cancer Hospital Foundation 57357 1 Seket El-Emam Street, El-Sayeda Zainab, Cairo Governorate Cairo +02 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University 9 Al Gameya, Oula, Giza, Giza Governorate Cairo +02 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Children's Cancer Hospital Egypt 57357 1 Seket El-Emam street, El-Sayeda Zainab, Cairo Governorate Cairo +02 Egypt Hospital
Primary Sponsor Faculty of Physical therapy, Cairo University El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432 Cairo +02 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Faten Hassan Abd El-Azim El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432 Cairo +02 Egypt
Dr. Wael Zekri Khaled 1 Seket El-Emam, El-Sayeda Zainab, Cairo Governorate Cairo +02 Egypt
Mahmoud Usama 16th El-Terra Street, Ezbet El-Nakhl Cairo +02 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Hassan Abd El-Aziem faten.hassan@pt.cu.edu.eg +2 01008554818 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki
City Postal code Country Position/Affiliation
Giza +02 Egypt Chairperson and Professor Doctor at Pediatric Physical Therapy Department, Cairo University, Egypt
Role Name Email Phone Street address
Public Enquiries Hamada El-Sayed Ayob hamada.ayob@pt.cu.edu.eg +2 01220313532 Hadayek El-Ahram, Giza Governorate
City Postal code Country Position/Affiliation
Giza +02 Egypt Lecturer at Pediatric Physical Therapy Department
Role Name Email Phone Street address
Scientific Enquiries Elham El-Sayed Salem elham.salem@pt.cu.edu.eg +2 01001002417 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
City Postal code Country Position/Affiliation
Giza +02 Egypt Professor Doctor at Pediatric Physical Therapy Department
REPORTING
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