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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250902067106N1
Enrollment
8
Registered
2025-09-19
Start date
2025-09-16
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar level spinal cord injury. Other and unspecified injury of lumbar and sacral spinal cord

Interventions

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 ort

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahmood Bahramizadeh

University of social welfare and rehabilitation sciences

Ma.bahramizadeh@uswr.ac.ir009822180010

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026