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IRCT20201128049511N2 IRCT 2021-12-25 Tarbiat Modares University Effects of Instrument-Assisted Soft Tissue Release on Walking and Sit to Stand in Individuals with Knee Osteoarthritis Effect of Instrument-Assisted Soft Tissue Mobilization on Gait and Sit to Stand Task Biomechanics in Individuals with Knee Osteoarthritis 2022-01-05 anticipated 34 Complete https://irct.ir/trial/59573 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: People are randomly divided into two groups. The intervention group receives the instrument along with exercise therapy. The control group will receive the instrument as a placebo along with exercise therapy, Randomization description: Participants will be randomly divided into two groups: treatment and placebo. In this way, four blocks are identified, of which two blocks belong to the placebo group and two blocks belong to the treatment group, Blinding description: Participants are unaware of the allocation of study groups. The treatment in the two groups is quite similar, and the only difference in the use of tools in the placebo group is that they are exactly the same instruments used in the treatment group, but the intensity of pressure and the type of movement of the tool are different. The intensity of pressure and type of movement are two subjects that patients do not have and will not notice if they are in the placebo or treatment group. The outcome assessor is also unaware of the grouping of individuals. N/A Knee Osteoarthritis. Intervention 1: Intervention group: A series of lightweight steel instruments are gently applied to the muscles around the knee. The movement of the instrument in specific therapeutic directions is applied to the skin based on the initial assessment, and an emollient is used to move the instrument more easily. The treatment time with this tool is approximately five minutes. Then stretching and strengthening exercises are performed. Intervention 2: Control group: Steel instruments are gently applied to the muscles around the knee in this group. Using an emollient, the instrument is applied as a placebo with the least amount of pressure on the skin in all directions. The tool is moved on the patient's skin in different directions without considering the initial assessment. The direction and pressure applied by the instrument have no therapeutic properties. The treatment time is approximately five minutes. Then stretching and strengthening exercises are performed. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared after people are not identified When: After the results are published, the access phase started six months later To whom: Researchers in academic and research organizations will also have access to the data Conditions: to do scientific research Where to obtain: Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University s.boozari@modares.ac.ir, 00982182885053 How to obtain: Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project Comments:
public Zahra Karimi Soluklo
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 5052 zahra_karimi@modares.ac.ir Tarbiat Modares University scientific Sahar Boozari
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 5053 s.boozari@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Women and men with osteoarthritis of the knee Ability to walk without the use of assistive devices Pain between three and six in one knee, according to the visual analogue scale A positive clark test result Grade two and three osteoarthritis, according to the Kellgren-Lawrence scale 45 years 80 years Both Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury Candidate for knee replacement surgery Any congenital disease of the lower extremities or lower back or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait or sit to stand task Joint injection in the last six months The difference in the length of the lower limbs is more than one and a half centimeters Medium to high intensity involvement of both knees Genovarum with a knee angle greater than 10 degrees A body mass index greater than 30 M17 Osteoarthritis of knee Treatment - Other Placebo Intervention group: A series of lightweight steel instruments are gently applied to the muscles around the knee. The movement of the instrument in specific therapeutic directions is applied to the skin based on the initial assessment, and an emollient is used to move the instrument more easily. The treatment time with this tool is approximately five minutes. Then stretching and strengthening exercises are performed. Control group: Steel instruments are gently applied to the muscles around the knee in this group. Using an emollient, the instrument is applied as a placebo with the least amount of pressure on the skin in all directions. The tool is moved on the patient's skin in different directions without considering the initial assessment. The direction and pressure applied by the instrument have no therapeutic properties. The treatment time is approximately five minutes. Then stretching and strengthening exercises are performed. Gait and sit to stand task kinematic and kinetic variables. Timepoint: Before and after the Intervention. Method of measurement: Inverse dynamics and force plate. Pain. Timepoint: Before and after the Intervention. Method of measurement: Visual analogue scale. Strength. Timepoint: Before and after the Intervention. Method of measurement: Dynamometer. Musculoskelatal performance. Timepoint: Before and after the Intervention. Method of measurement: Functional tests. Range of motion. Timepoint: Before and after the Intervention. Method of measurement: Goniameter. Quality of life. Timepoint: Before and after the Intervention. Method of measurement: Questionnaire. Tarbiat Modares University Approved 2021-10-23 Ethics committee of Tarbiat Modares University Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)