The Reliability of Compliance Monitors to Assess Wearing Time of Thoracic-Lumbar-Sacral Orthosis in Children with Spinal Cord Injuries (SCI)

Purpose: To determine the reliability of compliance monitors to assess thoracic-lumbar-sacral orthosis (TLSO) wearing time by children with spinal cord injury and evaluate the validity of compliance monitors by comparing them to gold standard (observation) assessment.

Significance: This study represents the first of two studies to determine the effectiveness of a TLSO in slowing the progression of paralytic spine deformity. The outcome of this study will determine which compliance monitor(s) will be used in a future study in which children will be randomly assigned into a TLSO group or control group. The compliance monitor will be used to ensure wearing time of the TLSO group.

Methods: The sample will be comprised of 30 subjects between five, six and fifteen years of age with cervical or thoracic level of spinal cord injury (SCI). Subjects will be recruited from Shriners Hospital for Children in Philadelphia (N=10), Chicago (N=10) and Northern California (N=10) hospitals. With informed consent and assent, all children will participate in the study during a routine admission to the rehabilitation unit for clinical/rehabilitation services.

Three small compliance monitors will be attached to the TLSO brace. If for some reason the TLSO brace cannot have the monitors attached, a new TLSO brace with the monitors will be fabricated. Two of the monitors, heat-sensitive monitors (Tidbit and HoBo 4-Channel External brace monitors), will be attached to the front of the TSLO brace. The third monitor, (IntelliBRACE), sensitive to pressure will be placed according to individual pressure mapping.

For four consecutive days, a research assistant will keep a log of the brace wear time. During this time, the participant will go through their normal rehabilitation program. At the end of each of the four days, the monitors will be checked and logged electronically. Comparison of the data among monitors will determine which monitor is most reliable. Validity of compliance monitors will be determined by comparing the monitor’s data with observation data.