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.: PACTR201705002185198 Date of Approval: 07/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Physical -Therapy
Official scientific title Clinical effectiveness of domestic aquatic therapy device after fixation of spinal burst fractures
Brief summary describing the background and objectives of the trial Rehabilitation is a goal-oriented and time-limited process that focuses on making a functionally impaired person reach an optimal mental, physical and social functional level.Patients with fractures could subject themselves to low-intensity exercise and gentle strengthening programs.low-income patients can benefit from hydrotherapy, consequently, psychological, social and economic burdens can decrease.This study will appraise the quality of hydrotherapy in reducing pain, improving body awareness and restoring the functional level after spinal fractures fixation. It aims also to improve strength, balance, and consequently gait pattern which are important elements of the rehabilitation process.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Post spinal fixation of burst fracture
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 06/04/2017
Actual trial start date 06/04/2017
Anticipated date of last follow up 06/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised In the reception of outpatient clinic, patients requested to draw sealed envelop using a random sequence numbers tabled for selection 1,2,3,...etc for group A and group B respectively In the reception of outpatient clinic, patients requested to draw an opaque sealed envelop using a random numbers tabled selection 1,2,3,...etc for group A and group B respectively Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hydrotherapy+standardized land-based exercise Program Half an hour session,3 times a week,for 3 months 3 months Steralized domestic hydrotherapy device having a stainless steel ladder with hand rails, firm floor surface, paralell bars for gait training, wall side bars, balance boards, seat for exercises, head rest and tools to train limbs, and water agitator+ land exercises such as: static then dynamic back exercises from supine lying position, raising arms up alternatively from prone, quadriped position ex 15 Active-Treatment of Control Group
Control Group Standardized land-based exercise program Half an hour session,3 times a week,for 3 months 3 months Static then, dynamic back exercise program, alternate arm raising overhead from prone lying program, exercises from quadriped position, exercises using therapeutic ball, exercises on wall bar, balance on wouble boards 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with spinal fixation as a result of burst fracture to the thoracolumbar vertebrae, adults, one week post operatively cardiovascular or peripheral vascular disease; circulatory insufficiency; diabetes; neurologic or muscular pathologies; open wounds; local hot or cold insensitivity; hypersensitivity; cryoglobulinemia; Raynaud's disease; paroxysmal cold hemoglobinuria; severe deformity; history of knee surgery or knee trauma; lack of communication skills & inability to comply with exercise protocol. Recent Heart Attack or Resting Angina Wound Infection Skin Infection Recent Neurological Event Recent Chemotherapy or Radiotherapy Recent DVT or Pulmonary Embolism Incontinence Sexually transmitted Infections/disease eg HIV, AIDS and Herpes Widespread MRSA Febrile patients Shortness of Breath at rest Over 21 stone or 130 kilo Uncontrolled Epilepsy Uncontrolled Diabetes 15 Year(s) 35 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 04/04/2017 Ethical committee of the faculty of physical therapy, Beni Suef University
Ethics Committee Address
Street address City Postal code Country
Eastern Nile river bank, New Beni Suef city, Beni Suef, Egypt Beni Suef 62764 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain After four weeks of therapy
Secondary Outcome Thoracolumbar range of motion After 3 months of therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ethar Physical therapy center Block 23, enterance 2, old police point, Elzaweya elhamra, Cairo, Egypt Cairo 11659 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The author 30 Ashara street, Kesm Hadayek el kobba Cairo 11646 Egypt
The author 30 Ashara street, Kesm Hadayek el kobba Cairo 11646 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor No No No No Egypt University
Secondary Sponsor I do not have 0000000 No 00000 University
COLLABORATORS
Name Street address City Postal code Country
Beni Suef University Eastern Nile river bank, New Beni Suef city Beni Suef 62764 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Ragab dr.ibrahimragab@outlook.com +201006796917 30 Ashara street, Kesm Hadayek el kobba, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11646 Egypt Lecturer of Orthopedic physical therapy, faculty of physical therapy, Beni Suef University
Role Name Email Phone Street address
Public Enquiries Ibrahim Ragab dr.ibrahimragab@outlook.com +201006796917 30 Ashara street, Kesm Hadayek el kobba, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11646 Egypt Lecturer of Orthopedic physical therapy, faculty of physical therapy, Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Ragab dr.ibrahimragab@outlook.com +201006796917 30 Ashara street, Kesm Hadayek el kobba, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11646 Egypt Lecturer of Orthopedic physical therapy, faculty of physical therapy, Beni Suef University
REPORTING
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