Recruiting

Observational Study

Sponsor:

University of St. Augustine for Health Sciences

Code:

NCT06419049

Conditions

Spina Bifida

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Altimate Medical EasyStand Bantam

Study Details

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. 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?

Conditions

Spina Bifida

Study ID

NCT06419049

Start date

Feb 23, 2023

Status verified date

May, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standing Program Intervention

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.

no intervention: Reliability

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

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

Primary outcome measure

  • Goniometric Measurements [ Time Frame: Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks. ]
  • 10 Meter Walk Test [ Time Frame: Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks. ]

Central Contacts and Locations

Central contacts

Marianne Hanover, DPT

7604105338mhanover@usa.edu

Locations

University of St. Augustine

Recruiting

San Diego, California, United States, 92069

Contacts

Marianne Hanover, DPT

760-410-5338

More Information

Sponsor

University of St. Augustine for Health Sciences

Last update posted

May 17, 2024

Last verified

May, 2024

Keywords

  • Spina Bifida
  • Standing Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of St. Augustine for Health Sciences on 2024-05-17.