Completed

NCT Number: NCT05251740

Impact of a Standing Program in a Child With Spina Bifida: A Case Report

The purpose of this case study is to investigate a child with MMC who has significant knee and hip flexion contractures to answer the following research questions: 1) Is a home standing program effective in reducing hip and knee flexion contractures in a child with MMC? 2) Does a home standing program result in a change in the quality of functional movement?

A Physical therapist, PT, will administer the Peds NRS and goniometric measurements prior to the start of the study and at the end of the study. The PT will also provide the parent instruction on the standing home program with weekly check-ins to ensure the parent and child are able to follow the home program. The home standing program will last 8 weeks. The parent will keep a written log of stander use. The Peds NRS scores and goniometric measurements will be compared pre and post intervention. The expected outcome is that the Peds NRS scores and hip and knee extension range of motion measurements will improve.

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Key information

Conditions

Spina Bifida With Hydrocephalus

Age range

9 year–9 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of St. Augustine

San Marcos, California, 92069, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

diagnosis of Spina Bifida
be able to stand with an assistive device

Exclusion criteria

a diagnosis unrelated to Spina Bifida that limits standing
medical restrictions that contraindicate standing

Treatment and study plan

Altimate Medical EasyStand Bantam

Device

The child will stand in the device for 60 min per day, 5 days per week for 2 months.

Primary outcomes

Goniometric measurements

Time frame: At 0 weeks

A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Goniometric measurements

Time frame: At 8 weeks

A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Pediatric Neuromuscular Recovery Scale (Peds NRS)

Time frame: At 0 weeks

The Pediatric Neuromuscular Recovery Scale (Peds NRS) assesses the quality of functional movement in children with MMC ages 1-12years. The Peds NRS examines the quality of sitting, upper extremity function, standing, and walking.The examiner administers the Peds NRS using a height-adjustable bench, mat table, fine motor manipulatives, and a ball. The examiner scores each of the 13 items on the Peds NRS on a 12-point scale, with one point allocated to each of the 12 phases of the item. The examiner scores the highest phase achieved by the child. A summary score is obtained using the sum of the items.
Pediatric Neuromuscular Recovery Scale (Peds NRS)

Time frame: At 8 weeks

The Pediatric Neuromuscular Recovery Scale (Peds NRS) assesses the quality of functional movement in children with MMC ages 1-12years. The Peds NRS examines the quality of sitting, upper extremity function, standing, and walking.The examiner administers the Peds NRS using a height-adjustable bench, mat table, fine motor manipulatives, and a ball. The examiner scores each of the 13 items on the Peds NRS on a 12-point scale, with one point allocated to each of the 12 phases of the item. The examiner scores the highest phase achieved by the child. A summary score is obtained using the sum of the items.

Sponsors and collaborators

Lead sponsor

University of St. Augustine for Health Sciences

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Feb 23, 2022
Registry last updated: Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.