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

This study investigates the effects of neuro-mechanical and conventional thoracolumbosacral orthoses on trunk control, sitting balance, respiratory function, and pain in individuals with spinal cord injury, and compares the two to guide the development of an optimized orthosis for improved sensorimotor function and rehabilitation.

This is an exploratory randomized controlled trial with a two-group parallel design on 8 patients. Blinding will not be performed in this study.

In the first session, participants visit the Technical orthopedic clinic at the University of Social Welfare and Rehabilitation Sciences, where eligibility criteria are assessed and initial measurements for orthosis fabrication are performed. In the second session, participants are randomly assigned to groups, and tests are conducted first without and then with the orthosis in randomized order. Orthoses are used daily for four weeks; the intervention group activates the sensory mechanism twice daily for 20 minutes. After four weeks, tests are repeated.

Participants must be ≥18 years old with T8–T12 spinal cord injury impairing trunk stability and requiring a thoracolumbosacral orthosis. At least 12 months post-injury, with no orthosis used in the past 2–3 months. ASIA B–D and neuropathic pain >4. Exclusions: severe musculoskeletal, cognitive, psychological disorders, comorbidities, implants, or pregnancy.

In the intervention group, participants use a thoracolumbosacral orthosis with neuro-mechanical features, activating its sensory stimulation mechanism twice daily; the control group uses a conventional thoracolumbosacral orthosis without these features.

Trunk control, sitting balance, respiratory function, and pain

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.

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.

Information is shared after the results are printed or summarized.

Researchers working in academic institutions.

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.

Individuals can request information from the person in charge.

Requests should be sent to Dr. Mahmood Bahramizadeh (ma.bahramizadeh@uswr.ac.ir).