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IRCT20240514061793N3 IRCT 2025-10-03 Tehran University of Medical Sciences Using Electrical Stimulation to Improve Balance and Daily Activities in Spinal Cord Injury Patients Construction and evaluation of the effect of Thoracolumbosacral Orthosis with Transcutaneous Electrical Nerve Stimulation Mechanism on balance, walking speed, and pain in Individuals with chronic Spinal Cord Injury 2025-10-04 anticipated 8 Recruiting https://irct.ir/trial/86491 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: The sequence of interventions will be randomized. Randomization will be performed using a block randomization method. The random sequence will be generated using a computer software (Random Allocation Software, version 2.0). Allocation concealment will be ensured by using sealed, opaque, and sequentially numbered envelopes. N/A Lumbar level spinal cord injury. Intervention 1: Intervention group: 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. Intervention 2: Intervention group: Participants in the same 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. Yes - There is a plan to make this available What will be shared: The study data 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 balance, walking speed, 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) Patients diagnosed with spinal cord injury confirmed by clinical and imaging findings. Age between 40 and 70 years. Ability to walk at least 10 meters with or without assistive devices. Stable medical condition for at least one month prior to enrollment. No severe cognitive impairment (MMSE score ≥ 24). Willingness to participate and provide informed consent. 18 years no limit Both S34.1 Other and unspecified injury of lumbar and sacral spinal cord Rehabilitation Rehabilitation Intervention group: 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. Intervention group: Participants in the same 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. Balance score of timed up and go test. Timepoint: Immediately post intervention. Method of measurement: Timed up and go test. Speed score of six meter walk test. Timepoint: Immediately post intervention. Method of measurement: Six meter walk test. Pain intensity measured on the Visual Analog Scale for pain. Timepoint: Immediately post intervention. Method of measurement: Visual Analog Scale. Tehran University of Medical Sciences Approved 2025-09-21 Ethics committee of Tehran University of Medical Sciences Keshavarz Boulevard, Qods Boulevard, Central Headquarters of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)