Soft lumbosacral brace to support the natural lower-back curve and improve posture and walking in children with cerebral palsy
The Effect of a Soft Lumbosacral Body Brace Supporting Physiological Lordosis on Postural Control and Walking Speed in Children With Cerebral Palsy
This study will test whether a soft lower-back brace that supports the natural lumbar curve can improve posture control and walking speed in children aged 6–15 with cerebral palsy who walk at GMFCS levels I–II.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kahramanmaraş, onikişubat) |
| Trial ID | NCT07186036 on ClinicalTrials.gov |
What this trial studies
This interventional trial will fit ambulatory children with cerebral palsy (ages 6–15, GMFCS I–II) with a soft lumbosacral orthosis designed to support physiological lumbar lordosis. Researchers will measure postural control and walking speed using standardized clinical and gait assessments before and after brace use. The sample size was calculated with G*Power (effect size 0.80, α=0.05, power=0.95) and participants will be recruited from rehabilitation centres in Gaziantep and Kahramanmaraş. Demographic and clinical information will be recorded and individuals with major orthopedic problems or insufficient cooperation will be excluded.
Who should consider this trial
Good fit: Ideal candidates are children with cerebral palsy aged 6–15 who walk independently (GMFCS levels I–II), can cooperate with testing, and have no major orthopedic conditions affecting balance.
Not a fit: Children with higher GMFCS levels, significant orthopedic problems that affect balance, or those unable to cooperate are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the brace could improve standing balance and increase walking speed, making daily mobility easier for ambulatory children with cerebral palsy.
How similar studies have performed: Some small clinical reports and orthotic practice suggest spinal support can help posture and gait in cerebral palsy, but well-powered trials of soft lumbosacral braces are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:Children with cerebral palsy * Aged 6-15 years * GMFCS 1-2 * Voluntarily participating in the study Exclusion Criteria:Children with cerebral palsy * Inappropriate GMFCS level * Presence of orthopaedic problems that may affect balance * Lack of cooperation from the individual
Where this trial is running
Kahramanmaraş, onikişubat
- Kahramanmaraş Sütçü İmam Üniversitesi — Kahramanmaraş, onikişubat, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Asiya Uzun Assistant Proffesor
- Email: asiyauzun@ksu.edu.tr
- Phone: +90(344) 300-2621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.