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.: PACTR201801002854243 Date of Approval: 09/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of core stabilization exercise on balance and gait in patients with total hip arthroplasty:Randomized controlled trial
Official scientific title Effect of core stabilization exercise on balance and gait in patients with total hip arthroplasty
Brief summary describing the background and objectives of the trial Patients with total hip arthroplasty (THA) are reported to have a higher incidence of falls compared to the general population; one in four patients is reported to have a fall within 2¿years following THA. The cost of falling is high, both to the individual (physical and psychological trauma) and the health-care system (financial burden related to surgery and rehabilitation). At the same time, costs related to the patient¿s inability to care for themselves and/or to be discharged to their home environment present additional burdens for the patient, their family, and the health-care system. The lumbo-pelvic-hip complex, often de¿ned as the ¿core,¿ consists of musculoskeletal structures that are responsible for stabilizing the spine and pelvis as well as facilitating the movements of distal limbs. Optimal function of lumbo- pelvic-hip muscles have been thought to enhance trunk stability and muscle coordination and, in theory, reduce risk of injury. Purpose of the study is to determine the effect of core stabilization exercise on balance and gait in patients with total hip arthroplasty.Apilot study will be conducted to detect the sample size. patients aged between 50-65 years old who recently had THA will be assigned randomly into two groups. Group A will have 10 weeks of conventional physical therapy followed by 4 weeks of aerobic exercise and core stabilization exercise & group B will have 10 weeks of conventional physical therapy followed by 4 weeks of aerobic exercise training. Biodex balance system will be used to measure balance and kinovea software analysis camera system will be used to measure spatiotemporal gait parameters pre and post rehabilitation program.
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,Surgery,Total hip arthroplasty
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 08/01/2018
Actual trial start date
Anticipated date of last follow up 04/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
Recruitment status Not yet 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 using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group convetional Rehab combined with core stabilization exercise 40 min three times a week 14 weeks convetional Rehab combined with core stabilization exercise 30 Active-Treatment of Control Group
Control Group conventional Rehab program 40 min three times a week 14 weeks conventional Rehab program 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients' age ranges from 50 to 65 years old male patients. BMI of all subjects were <30 Kg/m2. Patients must have undergone total hip arthroplasty recently. All patients are medically stable. All patients should be conscious and ambulant. Young individuals (their age below 50 years) and old individuals (their age above 65 years). Obese patients with BMI <30 Kg/m2. Patients with spinal pathology or neurological diseases that may affect gait or balance Structural discrepancy as leg length discrepancy. Cognitive impaired patients. Patients with history of epilepsy. Patients with cardiac pacemaker. 50 Year(s) 65 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
No 05/01/2018 faculty of physical therapy ethics comittee
Ethics Committee Address
Street address City Postal code Country
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No faculty of physical therapy, cairo university ethics commitee
Ethics Committee Address
Street address City Postal code Country
7 ahmed al zayat street, giza giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall Stability Index (OSI), Anterior/Posterior Stability index (APSI), and Medial/Lateral Stability index (MLSI). pre-Rehabilitation and post-rehabilitation week 2 postoperatively week 14 post operatively
Primary Outcome Spatiotemporal gait parameters in this study will include measurement of BOS, step length, stride length, gait velocity, and cadence. pre-Rehabilitation and post-rehabilitation week 2 postoperatively and week 14 post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy, cairo university 7 ahmed al zayat street Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy, cairo university 7 ahmed al zayat street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy, cairo university 7 ahmed al zayat street Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr.neveen abd el latif 7 ahmed el zayat street Giza Egypt
dr. yasser mohamed anees 7 ahmed el zayat street Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator neveen abd el raoof dr_neveen_69@yahoo.com 00201064615553 7 ahmed al zayat street
City Postal code Country Position/Affiliation
giza Egypt head of basic science department- faculty of physical therapy- cairo university
Role Name Email Phone Street address
Public Enquiries neveen abd el raoof dr_neveen_69@yahoo.com 00201064615553 7 ahmed al zayat street
City Postal code Country Position/Affiliation
giza Egypt head of basic science department- faculty of physical therapy- cairo university
Role Name Email Phone Street address
Scientific Enquiries yasser anees dryassercom@yahoo.com 00201001743830 7 ahmed al zayat street
City Postal code Country Position/Affiliation
Giza Egypt prof assistant-dep of basic science- faculty of physical therapy- cairo university
REPORTING
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Changes to trial information