Home standing program for children with spina bifida
Impact of Standing Programs in Children With Spina Bifida: A Single Subject Design
This study is testing a home standing program for kids aged 5 to 12 with spina bifida to see if it helps improve their movement, daily activities, and overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | University of St. Augustine for Health Sciences Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06419049 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a home standing program for children aged 5 to 12 with spina bifida who have significant knee limitations. It aims to assess various outcomes including lower extremity passive range of motion, functional movement quality, daily activity performance, mobility, and health-related quality of life. The study employs a single-subject ABABA design over 28 weeks, alternating between baseline and intervention phases. Measurements will be taken bi-weekly to evaluate the impact of the standing program on the participants.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 12 with spina bifida who can lay supine and walk 10 meters.
Not a fit: Patients with medical restrictions that contraindicate standing or movement through full passive range of motion will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve mobility and quality of life for children with spina bifida.
How similar studies have performed: While similar approaches have been explored, this specific intervention design is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\) 5 to 12 years old, and 2) able to lay in a supine position on a plinth for testing and walk 10 meters. Participants will be excluded from the study if they have medical restrictions that contraindicate moving bilateral lower extremities through full passive range of motion (PROM), including but not limited to joint motion bony blocks, fractures before bone healing is complete, acute inflammatory or infectious process, disruption of soft tissue healing is likely, sharp, acute pain with joint movement or muscle elongation, hematoma or other soft tissue trauma, hypermobility and walking 10 meters. Exclusion Criteria: Participants will be excluded from the study if they have: 1) a diagnosis unrelated to MMC form of SB that limits standing, 2) a Modified Hoffer Scale level of 5, indicating an inability to ambulate. 3) medical restrictions that contraindicate standing, including but not limited to fractures and severe osteoporosis that precludes weight-bearing, and compromised cardiovascular or respiratory systems.
Where this trial is running
San Diego, California
- University of St. Augustine — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Marianne Hanover, DPT
- Email: mhanover@usa.edu
- Phone: 7604105338
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.