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IRCT201304084952N3 IRCT 2016-11-22 Vice chancellor for research of Tarbiat modares university Treatment of osteoporosis in patients with spinal cord injury Effect of 24 weeks advanced weight-bearing exercises with/without quadriceps and soleus functional electrical stimulation on femoral and tibial bone density indexes and functional activities in paraplegic spinal cord injury 2016-10-22 anticipated 30 Complete https://irct.ir/trial/5300 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Thoracic spinal cord injury. Condition 2: Lumbar spinal cord injury. Condition 3: Osteoporosis. Intervention 1: First group: Patients who are undergo advanced weight bearing exercises (quadruped, trunk twisting and raising, tall-kneeling). Intervention 2: Third group: Control group, No intervention. Intervention 3: Second group: Patients who will do trunk twisting and raising exercise alone and do quadruped and tall-kneeling with quadriceps and soleus functional electrical stimulation.
public Mostafa Rahimi
No.34, south Taheri alley, west 196 St, Tehranpars
Tehran Iran (Islamic Republic of) 1655717913 +98 21 7787 3060 mostafa.rahimi@modares.ac.ir Tarbiat Modares university scientific Dr Giti Torkaman
Jalal Al Ahmad St
Tehran Iran (Islamic Republic of) 14115-111 +98 21 82880 torkamg@modares.ac.ir Tarbiat modares university Iran (Islamic Republic of) Inclusion major criteria: Traumatic paraplegic spinal cord injury (T6 up T12 ,grade A or B); Since the lesion is at least 1 year; Age between 20 and 40 years; Ability to respond to electrical stimulation of the quadriceps and soleus muscles; Normal rang of motion in the hip, knee and ankle joints; medically stable; No previous fracture in areas that are scanned; No history of metabolic diseases and other disorders affecting calcium metabolism and density of bone, early menopause, cancer, arthritis, diabetes; No use the certain drugs affecting bone metabolism including steroids, estrogens, bisphosphonates and calcitonin, fluorides, thyroid hormones, lithium, anticonvulsants and anti-androgen; No routine and regular physiotherapy including weight bearing exercise program and electrotherapy during past 6 months. Exclusion major criteria: Lack of patient's cooperation; Creation of some problems such as fractures, infections. 20 years 40 years Both S24.1 S34.1 M81 Other and unspecified injuries of thoracic spinal cord Other injury of lumbar spinal cord Osteoporosis without pathological fracture Treatment - Other Other Treatment - Other First group: Patients who are undergo advanced weight bearing exercises (quadruped, trunk twisting and raising, tall-kneeling). Third group: Control group, No intervention Second group: Patients who will do trunk twisting and raising exercise alone and do quadruped and tall-kneeling with quadriceps and soleus functional electrical stimulation. Total bone mineral density. Timepoint: Before and after 24 weeks intervention. Method of measurement: quantitative compute tomography. Total cross section area. Timepoint: Before and after 24 weeks intervention. Method of measurement: quantitative compute tomography. Trabecular bone mineral density. Timepoint: Before and after 24 weeks intervention. Method of measurement: quantitative compute tomography. Cortical cross section area. Timepoint: Before and after 24 weeks intervention. Method of measurement: quantitative compute tomography. Cortical bone mineral density. Timepoint: Before and after 24 weeks intervention. Method of measurement: quantitative compute tomography. Cortical thickness. Timepoint: Before and after 24 weeks intervention. Method of measurement: quantitative compute tomography. Number of practice of trunk twisting and raising exercise. Timepoint: Before and after 24 weeks intervention. Method of measurement: Count. Time exposure of quadruped position. Timepoint: Before and after 24 weeks intervention. Method of measurement: Digital timer. Time exposure of tall-knelling position. Timepoint: Before and after 24 weeks intervention. Method of measurement: Digital timer. Time exposure of forward reaching position. Timepoint: Before and after 24 weeks intervention. Method of measurement: Digital timer. Patient’s general health survey. Timepoint: Before and after 24 weeks intervention. Method of measurement: Persian version of the SF-36 questionnaire. Level of independence in daily activities. Timepoint: Before and after 24 weeks intervention. Method of measurement: Persian version of the Barthel index. Vice chancellor for research of Tarbiat modares university Approved 2016-09-22 Ethical committee of Tarbiat modares university Jalal Al Ahmad Street Tehran Iran (Islamic Republic of)