RecruitingNot ApplicableNCT06419049

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


Sponsor

University of St. Augustine for Health Sciences

Enrollment

12 participants

Start Date

Feb 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this single-subject study is to investigate children with spinal bifida who have significant knee limitations in lower extremity passive range of motion to answer the following research questions: 1. Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida? 2. Does a home standing program change the quality of functional movement in children with spina bifida? 3. Does a home standing program change a child's performance in daily activities, mobility, and social/cognitive domains? 4. Does a home standing program change a child's health-related quality of life in children with spinal bifida? 5. Does a home standing program result in a change in gait velocity in children with Spina Bifida?


Eligibility

Min Age: 5 YearsMax Age: 12 Years

Inclusion Criteria1

  • \) 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 Criteria1

  • 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.

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Interventions

DEVICEAltimate Medical EasyStand Bantam

Child will stand in stander 5 days per week for 60 min during each 8 wks intervention


Locations(1)

University of St. Augustine

San Diego, California, United States

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NCT06419049


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