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Search / Trial NCT06419049

Impact of Standing Programs in Children With Spina Bifida: A Single Subject Design

Launched by UNIVERSITY OF ST. AUGUSTINE FOR HEALTH SCIENCES · May 13, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Spina Bifida Standing Device

ClinConnect Summary

This clinical trial is studying the effects of a home standing program on children with Spina Bifida, a condition that can affect their ability to move their legs fully. The main goal is to see if this program can help improve the movement in their legs, make it easier for them to perform daily activities, and enhance their overall quality of life. The researchers will also look at how standing may help these children walk faster and improve how they move in general.

To participate, children must be between 5 and 12 years old, able to lie down flat on a padded surface for testing, and capable of walking 10 meters (about the length of a basketball court). However, children with certain medical conditions or severe restrictions on their movement will not be eligible. If selected, participants will engage in the standing program at home, and the researchers will monitor their progress over time. This trial could provide valuable information on how simple activities like standing can make a big difference in the lives of children with Spina Bifida.

Gender

ALL

Eligibility 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.

About University Of St. Augustine For Health Sciences

The University of St. Augustine for Health Sciences is a leading institution dedicated to advancing health education and research. With a strong focus on innovative clinical practices, the university fosters a collaborative environment that encourages the development of evidence-based therapies and interventions. As a clinical trial sponsor, it emphasizes the integration of cutting-edge research with practical applications, aiming to enhance patient care and improve health outcomes. Through its commitment to academic excellence and interdisciplinary collaboration, the University of St. Augustine plays a pivotal role in shaping the future of healthcare.

Locations

San Diego, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported