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.

Study Overview

• Status: Completed
• Conditions: Spina Bifida With Hydrocephalus
• Intervention / Treatment: Device: Altimate Medical EasyStand Bantam

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Marcos, California, United States, 92069
      • University of St. Augustine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standing program; The child completes a 60-minute home standing program five days per week over eight weeks.	Device: Altimate Medical EasyStand Bantam; The child will stand in the device for 60 min per day, 5 days per week for 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goniometric measurements	A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).	At 0 weeks
Goniometric measurements	A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).	At 8 weeks
Pediatric Neuromuscular Recovery Scale (Peds NRS)	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.	At 0 weeks
Pediatric Neuromuscular Recovery Scale (Peds NRS)	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.	At 8 weeks

Collaborators and Investigators

• Sponsor: University of St. Augustine for Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2021
• Primary Completion (ACTUAL): July 8, 2021
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (ACTUAL): February 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Hydrocephalus; Spinal Dysraphism
• Other Study ID Numbers: 0329-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to include goniometric and Peds NRS results and describe the protocol used
• IPD Sharing Time Frame: July 2021, permanently
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No