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IRCT20220427054675N1 IRCT 2023-01-19 Shahid Beheshti University of Medical Sciences comparison of gate adaptability and symmetry outcomes between immediate post-operative prosthesis and classic methods in lower limb amputees IPOP comparison of gate adaptability and symmetry outcomes between immediate post-operative prosthesis and classic methods in lower limb amputees 2023-03-21 anticipated 98 Complete https://irct.ir/trial/63332 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: this research is a simple randomized controlled trial that random number tables are used before starting the research. even numbers are used for group A (interventional group) and odd numbers are used for group B (control group). To avoid disparity between group sizes, we used replacement randomization. If the disparity exceeded the preset criterion of the study sample size, we generated another randomization list using simple randomization until we achieved a balanced group size, Blinding description: in this study patient could not blinded. doctors and all health providers could not be blinded neither because they are present at the surgery and post-surgery cares. but on the other hand all researchers and laboratory technicians and data analyzers all fully blinded. during musculoskeletal assessments all of the patients are wearing permanent prosthesis which give no information about the post-operative rehabilitation methods. In data extraction period all the subjects names are coded and no information about medical history of patients are provided for analyzers. To prevent revealing verbal communication between the evaluator and the patient, an observer (who does not have any information) will be present at the evaluation site. N/A trans-tibial (below knee) amputation. Intervention 1: Intervention group: In this group patients receive immediate post-operative prosthesis as a recovery and rehabilitation method. The immediate prosthesis has a thermoplastic socket, which is padded with 4 mm polyfoam. The volume of the socket can be adjusted through four straps. The patient uses this prosthesis for one month after surgery. In the first 3 days, stretching exercises are done to strengthen the muscles. In the next 3 to 5 days, standing exercises are performed with the application of limited weight (10 pounds on the first day and its gradual increase in the following days to a maximum of half the body weight) (a scale is placed under the patient's foot to accurately apply the amount of pressure). After this course, walking exercises will be done with a walker. Intervention 2: Control group: In this group patients receive classic methods (soft bandage). For these participants, the stitched area is covered with a soft bandage, and only exercises to strengthen the muscles of the arms and legs are provided to the person in a lying and sitting position. Yes - There is a plan to make this available What will be shared: gait parameters Data When: 1402-1403 To whom: academic faculty Conditions: retrospective studies Where to obtain: writers- email How to obtain: sending an email including research project documents Comments:
public Zahra Taghziadeh Herat
no1 ansari alley qeitarieh street
Tehran Iran (Islamic Republic of) 1938953130 +98 21 2267 1440 zahrataghizadehherat@gmail.com Shahid Beheshti University of Medical Sciences scientific seyed mahmoud mousavi ziarati
south JanatAbad st.
Tehran Iran (Islamic Republic of) 1474667168 +98 21 4444 8552 mousavi2m@outlook.com Esfahan University of Medical Sciences Iran (Islamic Republic of) trans-tibial(below knee) amputee informed consents of patient for entering the research age between 18 to 80 18 years 80 years Both k2 activity level and below lower limb bilateral amputation cognition disorder upper limb amputation No Light Perception (NLP) skin graft muscle contracture any other musculoskeletal disease that makes the walking by prothesis impossible soft tissue low quality that we concern about the wound remission Z89.5 Acquired absence of leg below knee Rehabilitation Rehabilitation Intervention group: In this group patients receive immediate post-operative prosthesis as a recovery and rehabilitation method. The immediate prosthesis has a thermoplastic socket, which is padded with 4 mm polyfoam. The volume of the socket can be adjusted through four straps. The patient uses this prosthesis for one month after surgery. In the first 3 days, stretching exercises are done to strengthen the muscles. In the next 3 to 5 days, standing exercises are performed with the application of limited weight (10 pounds on the first day and its gradual increase in the following days to a maximum of half the body weight) (a scale is placed under the patient's foot to accurately apply the amount of pressure). After this course, walking exercises will be done with a walker. Control group: In this group patients receive classic methods (soft bandage). For these participants, the stitched area is covered with a soft bandage, and only exercises to strengthen the muscles of the arms and legs are provided to the person in a lying and sitting position. Gait symmetry. Timepoint: 1, 6, and 12 months after permanent prosthesis application. Method of measurement: measuring of differences between lower limbs stride length, time, and speed. Gait adaptability. Timepoint: 1, 6, and 12 months after permanent prosthesis application. Method of measurement: 1. gait adaptability measurement is done in such a way that a laser line is displayed on the ground one step before the patient arrives and the person must be able to cross it. 2. The ability to cross the obstacle in such a way that one step before the patient arrives A plastic barrier with a height of 15 cm appears and the person must be able to pass through it. Shahid Beheshti University of Medical Sciences Approved 2022-09-11 shahidbeheshti university of medical science velenjak daneshjoo street medicine school tehran Tehran Iran (Islamic Republic of)