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IRCT20250902067106N1 IRCT 2025-09-19 University of social welfare and rehabilitation sciences Investigating the Effect of Thoracolumbosacral Orthosis with Neurological-Mechanical Features in Individuals with Spinal Cord Injury Investigating the Effect of Thoracolumbosacral Orthosis with Neurological-Mechanical Features on Trunk Control, Seating Balance, Respiratory Function, and Pain in Individuals with Spinal Cord Injury 2025-09-16 anticipated 8 Complete https://irct.ir/trial/86051 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this clinical trial, samples will be selected using convenience sampling and subsequently assigned to one of two groups (Thoracolumbosacral Orthosis with Neurological-Mechanical Features, Traditional Thoracolumbosacral Orthosis) utilizing the block randomization method. The unit of randomization is individual participants. An equal number of participants will be allocated to each study group, following a 1:1:1:1 ratio. To generate a random sequence of blocks, each group will be assigned a specific code, and the randomizer.org website will be employed. The order of participant entry will be determined using two blocks of size four. Once individuals meet the inclusion criteria and sign the consent form to participate in the study, they will be assigned to one of the groups based on the randomly selected block sequence. N/A Lumbar level spinal cord injury. Intervention 1: Participants in this group will use a thoracolumbosacral orthosis with neuro-mechanical features. After receiving training on proper usage and completing baseline tests without the orthosis, participants will wear the orthosis and repeat the tests while using it. Following this session, participants must use the orthosis daily for four weeks, and to activate its tension mechanism, they will use it twice a day for 20 minutes per session according to the specified schedule. Intervention 2: Control group: Participants in this group will use a conventional thoracolumbosacral orthosis. After receiving training on proper usage and completing baseline tests without the orthosis, participants will wear the orthosis and repeat the tests while using it. Following this session, participants must use the orthosis daily for four weeks, without any neuro-mechanical features or active tension mechanism. Yes - There is a plan to make this available What will be shared: The study information (data related to the scores of the Trunk Assessment Scale Score, Sitting Balance Score, Breath Holding Time, and Visual Analog Scale) will be shared with other researchers. When: Information is shared after the results are printed or summarized. To whom: Researchers working in academic institutions. Conditions: By performing statistical tests on the data, the applicants can evaluate the results of using the interventions of this study on on trunk Control, seating balance, respiratory function, and pain and use these data to conduct meta-analysis review studies. Where to obtain: Individuals can request information from the person in charge. How to obtain: Requests should be sent to Dr. Mahmood Bahramizadeh (ma.bahramizadeh@uswr.ac.ir). Comments:
public Mahmood Bahramizadeh
Kodakyar Ave., Daneshjo Blvd., Evin, Velenjak
Tehran Iran (Islamic Republic of) 1985713871 009822180010 Ma.bahramizadeh@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Mahmood Bahramizadeh
Kodakyar Ave., Daneshjo Blvd., Evin, Velenjak
Tehran Iran (Islamic Republic of) 1985713871 009822180010 Ma.bahramizadeh@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Participants in this study must be at least 18 years old. Individuals with a spinal cord injury at the T8 to T12 level, in such a way that trunk stability is impaired and, according to the physician’s judgment, require the use of a thoracolumbosacral orthosis. At least 12 months must have passed since the injury for individuals to be considered as chronic cases, as the plateau of neurological recovery usually occurs after this period. Participants must not have used a spinal orthosis during the past two to three months. Individuals must be classified as grade B, C, or D according to the American Spinal Injury Association (ASIA) Impairment Scale. The presence of neuropathic pain, assessed using the Neuropathic Pain Scale, with a score greater than 4 indicating the existence of this type of pain. 18 years no limit Both S34.1 Other and unspecified injury of lumbar and sacral spinal cord Rehabilitation Rehabilitation Participants in this group will use a thoracolumbosacral orthosis with neuro-mechanical features. After receiving training on proper usage and completing baseline tests without the orthosis, participants will wear the orthosis and repeat the tests while using it. Following this session, participants must use the orthosis daily for four weeks, and to activate its tension mechanism, they will use it twice a day for 20 minutes per session according to the specified schedule. Control group: Participants in this group will use a conventional thoracolumbosacral orthosis. After receiving training on proper usage and completing baseline tests without the orthosis, participants will wear the orthosis and repeat the tests while using it. Following this session, participants must use the orthosis daily for four weeks, without any neuro-mechanical features or active tension mechanism. Trunk control score on the Trunk Assessment Scale Score. Timepoint: Before, immediately while using , and four weeks after wearing the orthoses. Method of measurement: Trunk Assessment Scale Score. Sitting balance score on the Sitting Balance Score. Timepoint: Before, immediately while using , and four weeks after wearing the orthoses. Method of measurement: Sitting Balance Score. Respiratory function score on the Breath-Holding Time test. Timepoint: Before, immediately while using , and four weeks after wearing the orthoses. Method of measurement: Breath Holding Time. Pain intensity measured on the Visual Analog Scale for pain. Timepoint: Before, immediately while using , and four weeks after wearing the orthoses. Method of measurement: Visual Analog Scale. University of social welfare and rehabilitation sciences Approved 2025-09-03 Ethics Committee of the University of Social Welfare and Rehabilitation Sciences kodakyar Ave, daneshjo Blvd, Evin, Velenjak Tehran Tehran Iran (Islamic Republic of)