Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury (NCT00256672) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness of Bracing in Preventing Scoliosis in Children With Spinal Cord Injury
United States88 participantsStarted 2005-06
Plain-language summary
The purpose of this study is to determine whether full-time high dose prophylactic bracing (23 hours or more per day) is more effective than low dose bracing (12 hours or less per day) in preventing or delaying spinal curve progression in children with scoliosis after spinal cord injury.
Who can participate
Age range
5 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Children with C5 to L2 SCI.
. ASIA impairment levels A, B, or C.
. Age greater than 5 up to one year before end of growth (14 in girls, 16 in boys)
. A single structural curve \<40 degrees or a double curve \<40 degrees where the largest compensatory curve is \<25 degrees on bending film.
. Children at risk for Paralytic Scoliosis
. Ability to follow simple instructions.
Exclusion criteria
. Curve magnitude \>40 degrees, pressure sores over the trunk.
. Inability to tolerate TLSO wears.
. Structural compensatory curves of 25 degrees or greater (double structural curves).
. Severe Traumatic Brain Injury, TBI (8 and below on Glasgow Coma Scale).
. Cognitive Impairment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
X-rays (at the time of consent and every 6 months for 5 years) to determine degree of scoliosis.
Timeframe: 5 years
2
Timed Motor Assessment (at the time of consent and once a year for 5 years) to measure functional ability in daily life activities including putting on sweat pants, T-Shirt, transferring from wheelchair to bed, etc.
Timeframe: 5 years
3
Reachable Workspace Assessment (at the time of consent and once a year for 5 years): performing functional tasks including reaching for the floor, overhead, and every 20-degree radius in between.
Timeframe: 5 years
4
Global Measures (at the time of consent and every 6 months for 5 years): Four different questionnaires to monitor function, satisfaction, and quality of life.