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IRCT20210717051913N1 IRCT 2021-09-03 University of social welfare and rehabilitation sciences The effect of spinal braces with exercise therapy in the elderly Comparison of the effect of orthosis spinomed and Posture Training Support with exercise therapy on the ability to walk and energy consumption in the elderly with hyperkyphosis 2021-09-25 anticipated 39 Complete https://irct.ir/trial/57572 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to one of three study groups with the help of a simple gradual random allocation method and receive the intervention of the same group. The randomization unit will be the client. With each patient's visit, one of the envelopes will be randomly selected by the patient and introduced as a study group. There will be no concealment in the study. N/A Hyperkyphosis. Intervention 1: Intervention group: Posture Training Suport orthosis with exercise therapy ,It is a small orthosis that prevents excessive bending by torque backwards on the spine. The orthosis is prefabricated, consisting of a sac located at the back just below the lower angle of the scapula and measuring 10-20 cm long and 5-10 cm wide. The orthosis will be ordered from Technotan Company in small, medium, large and very large sizes depending on the patient's size and will be covered by the orthotist on the patient's body. The person is asked to wear it for at least 2 hours a day during daily activities. Exercise therapy (exercise therapy) includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the muscles of the dorsal extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to perform these exercises in home every day as instructed and will be re-evaluated after 8 weeks. Intervention 2: Intervention group: Spinomed orthosis with exercise therapy, The orthosis is small , creating a backward torque to counteract excessive forward bending. It is a prefabricated orthosis that extends vertically up to the shoulder (1-5 cm below C7) from an abdominal pad, a vertical metal pad on the back, a belt and shoulder straps. The orthosis will be ordered from Technotan Company in small, medium, large and very large sizes depending on the patient's size and will be covered by the orthosis specialist based on the patient's size. The person is required to use at least two hours a day during daily activities. Exercise therapy (exercise therapy) includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the back extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to do these exercises in home every day as instructed and will be re-evaluated after 8 weeks. Intervention 3: Control group: exercise therapy, includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the back extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to do these exercises in home every day as instructed and will be re-evaluated after 8 weeks. Yes - There is a plan to make this available What will be shared: It is not possible to share all the data and only the demographic information of the participants and the results of the study evaluation variables are shared. When: Start of data access period 6 months after the publication of the article To whom: Researchers working in academic centers who intend to use these findings in systematic review and meta-analysis Conditions: Other researchers as well as therapists in the field of medicine and rehabilitation can use this study after the publication of the article. Where to obtain: University of Social Welfare and Rehabilitation Sciences, Hanie Khojasteh(hani_khojasteh@ymail.com) How to obtain: After requesting the documents, it is necessary for the person in charge of the research project to receive a written permit from the university and send the documents after obtaining the permit. Therefore, it is estimated that about 6 months after the request, this data will be sent. Comments:
public hanie khojasteh
Evin, Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Sciences
tehran Iran (Islamic Republic of) 1985713834 +98 21 2218 0109 hani_khojasteh@ymail.com University of social welfare and rehabilitation sciences scientific hanie khojasteh
Evin, Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Sciences
tehran Iran (Islamic Republic of) 1985713834 +98 21 2218 0109 hani_khojasteh@ymail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) People are 60-80 years old People have a kyphosis angle of 50-65 degrees People have the ability to walk without auxiliary devices People are able to stand for at least two minutes without assistance Individuals have the ability to score 1 or 2 on the clock drawing test 60 years 80 years Both People who have any neurological or muscular diseases. People with any sensory-muscular dysfunction. People with scoliosis. People who have had lower limb joint replacement. People with hearing or vision impairment. People with a history of spinal fractures or lower limb surgery in the past 12 months. People who have back or neck pain at the time of evaluation with VAS more than 3. M40.13 Other secondary kyphosis, cervicothoracic region Rehabilitation Rehabilitation Rehabilitation Intervention group: Posture Training Suport orthosis with exercise therapy ,It is a small orthosis that prevents excessive bending by torque backwards on the spine. The orthosis is prefabricated, consisting of a sac located at the back just below the lower angle of the scapula and measuring 10-20 cm long and 5-10 cm wide. The orthosis will be ordered from Technotan Company in small, medium, large and very large sizes depending on the patient's size and will be covered by the orthotist on the patient's body. The person is asked to wear it for at least 2 hours a day during daily activities. Exercise therapy (exercise therapy) includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the muscles of the dorsal extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to perform these exercises in home every day as instructed and will be re-evaluated after 8 weeks. Intervention group: Spinomed orthosis with exercise therapy, The orthosis is small , creating a backward torque to counteract excessive forward bending. It is a prefabricated orthosis that extends vertically up to the shoulder (1-5 cm below C7) from an abdominal pad, a vertical metal pad on the back, a belt and shoulder straps. The orthosis will be ordered from Technotan Company in small, medium, large and very large sizes depending on the patient's size and will be covered by the orthosis specialist based on the patient's size. The person is required to use at least two hours a day during daily activities. Exercise therapy (exercise therapy) includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the back extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to do these exercises in home every day as instructed and will be re-evaluated after 8 weeks. Control group: exercise therapy, includes exercises (8 exercises) to strengthen the back muscles. These exercises repeat the contraction of the back extensor muscles 10 times, reducing the angle of thoracic kyphosis without increasing lumbar lordosis. The person is asked to do these exercises in home every day as instructed and will be re-evaluated after 8 weeks Ability to walk (includes: distance traveled, walking speed and walking efficiency.). Timepoint: First, the relevant tests are taken from the subjects in the first session before the intervention, and after 8 weeks of the intervention (which includes orthosis with exercise therapy or exercise therapy alone (control group)), individuals are asked to refer to the center again and the tests Will be taken. Method of measurement: distance traveled (2- MWT) Two minutes of walking The maximum distance traveled is recorded (meters)/Walking speed (10-MWT) 10 meters A person walks. Time will be recorded in this distance. (M / s)/Walking efficiency (EMS) includes 7 functional dimensions that are examined in the person and will be given a score of 20 (score). Energy consumption. Timepoint: Energy consumption of individuals is recorded in the first session before the intervention and after 8 weeks of intervention (orthosis with exercise therapy or exercise therapy alone (control group)) people are asked to refer to the center and record energy consumption. Method of measurement: Using the polar electro device, the heart rate at rest and activity is recorded and the amount of energy consumption is calculated in the physiological cost index formula. Thoracic kyphosis angle. Timepoint: The Thoracic kyphosis angle will be recorded in the first session before the intervention. After 8 weeks of intervention (orthosis with therapeutic exercise or exercise therapy alone (control group)) again, individuals are asked to refer to the center and record the angle. Method of measurement: It will be recorded using a kyphometer device. University of social welfare and rehabilitation sciences Approved 2021-07-14 Ethics Committee of University of Social Welfare and Rehabilitation Sciences Tehran University of Social Welfare and Rehabilitation Sciences, Evin, Daneshjoo Blvd., Koodkiar dead end tehran Tehran Iran (Islamic Republic of)