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

NCT06419049 | Recruiting FDA Device

• 1 other identifier: 0819-275
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida?
2. 2.Does a home standing program change the quality of functional movement in children with spina bifida?
3. 3.Does a home standing program change a child's performance in daily activities, mobility, and social/cognitive domains?
4. 4.Does a home standing program change a child's health-related quality of life in children with spinal bifida?
5. 5.Does a home standing program result in a change in gait velocity in children with Spina Bifida?

Conditions

Spina Bifida

Keywords

Spina Bifida; Standing Device

Outcome Measures

Primary Outcomes (2)

• Goniometric Measurements

  A universal goniometer will be used to measure the child's hip and knee joint passive range of motion.

  Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.

• 10 Meter Walk Test

  The 10MWTpref measures gait velocity in youth with neurological diagnoses while using an assistive device and wearing orthoses

  Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks.

Secondary Outcomes (3)

• Pediatric Neuromuscular Recovery Scale (Peds NRS)

  Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks.

• Pediatric Evaluation of Disability Computer Adapted Test (PEDI-CAT)

  Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks

• Pediatric Quality of Life Inventory (PedsQL™)

  Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks

Study Arms (2)

Standing Program Intervention

EXPERIMENTAL

A single-subject study ABABA design will be used with dependent variables of passive range of motion, functional movement, functional skills performance, engagement, health related quality of life and gait velocity will be recorded repeatedly for the individual participants across time and with systematic manipulation of the independent variable, which is the standing home program intervention. The study will span 28 weeks for the intervention Stage 2, consisting of three baseline phases (A) of four weeks each and two home program intervention phases (B) of eight weeks each that alternate in an ABABA design.

Device: Altimate Medical EasyStand Bantam

Reliability

NO INTERVENTION

Children will be assessed by two study investigators in two different sessions on the same day, with a washout period of 3 hours between sessions. Intrarater reliability will be determined by comparing rater's scores for each child. These sessions will include goniometric measurements of lower extremity passive range of motion and the 10-Meter Walk Test. Children will have the opportunity to rest or resume normal activities with a minimum of 3 hours between sessions. Interrater reliability will be determined based on the measurements in the same session by 2 different raters.

Interventions

Altimate Medical EasyStand Bantam DEVICE

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

Standing Program Intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of St. Augustine for Health Sciences: lead

Study Sites (1)

University of St. Augustine

San Diego, California, 92069, United States

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Marianne Hanover, DPT

CONTACT

7604105338; mhanover@usa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single subject design

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: February 23, 2023
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

US (1)