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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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5 January 2021 |
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Main ID: |
ISRCTN30713542 |
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Date of registration:
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06/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The contribution of a modified physiotherapy exercise program in the overall functional ability of patients with femoral neck fracture after hemiarthroplasty
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Scientific title:
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The effect of modified physiotherapy intervention in postoperative abductors muscles efficiency and functional ability of hip-fractured patients. |
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Date of first enrolment:
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06/04/2012 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN30713542 |
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Study type:
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Interventional |
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Study design:
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Double-blind, stratified, randomized clinical trial. (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Greece
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Contacts
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Name:
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Sophia
Stasi |
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Address:
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30 Ouranias Street
P.C. 14121
Irakleio- Attica
Greece |
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Telephone:
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- |
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Email:
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soniastasi1@gmail.com |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Age 70?85 years
2.All participants must be ambulatory and must not have undergone any prior orthopaedic surgery in the fractured or contralateral hip
3. Willing to be assigned to either of the two study groups
Exclusion criteria:
1. Patients who have Body Mass Index (BMI) = 40 or suffering from dementia, chronic respiratory disease, chronic renal failure, heart failure, neurological disorder, undergoing chemotherapy
2. Postoperative will be measuring the length of the lower limbs and excluded patients presenting leg length discrepancies more than 20mm
3. Patients will also be excluded if they present postoperative complications, such as deep vein thrombosis, pulmonary embolism, pneumonia or delirium
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rehabilitation protocols in hip-fracture patients.
Musculoskeletal Diseases
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Intervention(s)
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Participants will be divided into 2 groups; control group and research group.
1. The control group will follow the classic physiotherapeutic protocol
2. The research group will follow the modified physiotherapeutic protocol
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Primary Outcome(s)
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Difference in postoperative functional status according to strengthening of hip abductor muscles. This is measured 60 days (3 months) after surgery in Newton (N) with a reliable electronic dynamometer.
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Secondary Outcome(s)
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1. At the day of hospital admission evaluation of the prefracture functional status using self-reported measure.
2. Evaluation of postoperative hip abductor muscles strength and functional status using both self-reported (using a questionnaire) and physical performance (Timed Up & Go Test) measures and an objective measure of abductors muscles strength using an electronic dynamometer(3rd and 6th month after surgery)
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Secondary ID(s)
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2413/21.11.11
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Source(s) of Monetary Support
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Investigator initiated and funded (Greece)
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Ethics review
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Status:
Approval date:
Contact:
1. General Assembly of Special Synthesis of Faculty of Medicine, School of Health Sciences, National and Kapodistrian University of Athens, Greece, 21/11/2011, ref: 2413/21.11.11)
2. Scientific Research Council of the ?KAT? General Hospital of Athens, Greece, 30/03/2012, ref:382/30-03-2012)
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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14/11/2015 |
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URL:
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