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IRCT20150131020888N10 IRCT 2018-11-23 Esfahan University of Medical Sciences The effect of treadmill exercise in subjects with bilateral knee osteoarthritis The effect of treadmill exercise with conventional physical therapy on the spatiotemporal parameters of the gait in subjects with bilateral moderate knee osteoarthritis 2017-08-01 anticipated 50 Complete https://irct.ir/trial/32571 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization base on random number table, Blinding description: The selected individuals will be informed about the study protocol in detail. They know that they will randomly be assigned into one of two groups that both will receive conventional physical therapy. They do not have the idea that by 50% they may be included in treadmill protocol. they only know that the exercise program is different between groups and there is 50% chance to be included in each group. they will be treated in the same place but not at the same time. Therefore, they do not have the opportunity to meet or observe the difference between groups. They do not know what kind of exercises are different between groups thus they will be blinded to groups' differences. The principal investigator (PI) will assign participant into treatment and control groups based on random number table. Employed physical therapist, who has no role in subjects evaluation, will manage both groups by a conventional physical therapy program. The same researcher who is blinded to study groups, will evaluate the subjects before and after 10 sessions of treatments in both groups. Data will be coded by PI and will be analysed by a analyzer who is blind to the study protocol. N/A Bilateral Moderate Knee Osteoarthritis. Intervention 1: Intervention group: Ultrasound (1 MHz, 1.5-2 W, 5 minutes, continuous) that covers the antero-medial and antro-lateral aspects of the knee around the patella. Acupuncture TENS (low rate: 2-10 HZ, 200-300 microsecond, 20 minutes), four electrodes over the superior and inferior medial and lateral poles of the patella. Hot moist pack for 20 minute. Quadriceps setting. Setting of the vastus medialis oblique (VMO). Education using an illustrated pamphlet. walking on the treadmill including one minutes walking with self-selected velocity [Warm-Up period], five minutes walking with gradual increase in velocity to reach threshold heart rate at the end of 5 minute. Threshold heart rate may be calculated as HRThreshold =70%HRMax where HRMax = 220-age, seven minutes walking with controlling velocity to preserve participant’s heart rate at threshold heart rate, one minute walking: self-selected velocity [Active Recovery] and five minutes rest at sitting position [Passive Recovery]. Intervention 2: Control group: Ultrasound (1 MHz, 1.5-2 W, 5 minutes, continuous) 1-2 minute per 1 cm2 that covers the antero-medial and antro-lateral aspects of the knee around the patella. Acupuncture TENS (low rate: 2-10 HZ, 200-300 microsecond, 20 minutes), four electrodes over the superior and inferior medial and lateral poles of the patella. Hot moist pack for 20 minute. Quadriceps setting. Setting of the vastus medialis oblique (VMO). Education using an illustrated pamphlet. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Zahra Sadat Rezaeian
Musculoskeletal Research Center, Department of Physical Therapy, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
Isfahan Iran (Islamic Republic of) 81746-73461 00983137925012; 00983137925042 zrezaeian@yahoo.com Esfahan University of Medical Sciences scientific Dr. Zahra Sadat Rezaeian
Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
Isfahan Iran (Islamic Republic of) 81745-164 +98 31 3792 5012; +983137925042 zrezaeian@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 40-70 years old Suffering from bilateral moderate knee osteoarthritis Stable baseline blood pressure 40 years 70 years Both Any uncontrolled metabolic, neurological (i.e. stroke, Parkinson, etc) or any cardiovascular problem that limit subjects ability to walk or cause any gait abnormality Any altered sensation or nerve damage over the anterior knee( due to precaution in use of electrical currents like TENS) Lower body fracture within 6 months History of arthroplasty in either lower limbs Presence of any acquired or congenital musculoskeletal dysfunction in lower limbs Major loss of vision Intra-articular steroid or hylan G-F 20 injection within the previous 6 months Presence of a severe medical condition that precluded safe participation in an exercise or gait program Inability to walk on a treadmill without an assistive device History of any joint inflammatory disease Involvement in another treatment program or study protocol Involvement any rehabilitation program within 6 months Acute low back pain or patellofemoral disorders M17 Osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: Ultrasound (1 MHz, 1.5-2 W, 5 minutes, continuous) that covers the antero-medial and antro-lateral aspects of the knee around the patella. Acupuncture TENS (low rate: 2-10 HZ, 200-300 microsecond, 20 minutes), four electrodes over the superior and inferior medial and lateral poles of the patella. Hot moist pack for 20 minute. Quadriceps setting. Setting of the vastus medialis oblique (VMO). Education using an illustrated pamphlet. walking on the treadmill including one minutes walking with self-selected velocity [Warm-Up period], five minutes walking with gradual increase in velocity to reach threshold heart rate at the end of 5 minute. Threshold heart rate may be calculated as HRThreshold =70%HRMax where HRMax = 220-age, seven minutes walking with controlling velocity to preserve participant’s heart rate at threshold heart rate, one minute walking: self-selected velocity [Active Recovery] and five minutes rest at sitting position [Passive Recovery]. Control group: Ultrasound (1 MHz, 1.5-2 W, 5 minutes, continuous) 1-2 minute per 1 cm2 that covers the antero-medial and antro-lateral aspects of the knee around the patella. Acupuncture TENS (low rate: 2-10 HZ, 200-300 microsecond, 20 minutes), four electrodes over the superior and inferior medial and lateral poles of the patella. Hot moist pack for 20 minute. Quadriceps setting. Setting of the vastus medialis oblique (VMO). Education using an illustrated pamphlet. Spatio-temporal parameters of gait include stride length; normalized stride length; average walking speed; cadence;stance time; stance percentage. Timepoint: Before and after 10 sessions of interventions in each groups. Method of measurement: Qualysis track manager. Pain. Timepoint: Before and after 10 sessions of interventions in each groups. Method of measurement: Visual analog scale(VAS); Intermittent and Constant Osteoarthritis Pain Score (ICOAP); Knee injury and Osteoarthritis Outcome Score (KOOS). Function. Timepoint: Before and after 10 sessions of interventions in each groups. Method of measurement: Knee injury and Osteoarthritis Outcome Score(KOOS); Six minute walk test and Get up and go test. Gait biomechanics (kinetics and kinematics) parameters. Timepoint: Before and after 10 sessions of interventions in each groups. Method of measurement: Qualysis track system and visual 3D software. Esfahan University of Medical Sciences Approved 2017-07-29 Ethics committee of Isfahan University of Medical Sciences Isfahan University Of Medical Sciences, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)