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

NCT05251740 | Completed FDA Device

• 1 other identifier: 0329-21
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spina Bifida With Hydrocephalus

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Standing program

EXPERIMENTAL

The child completes a 60-minute home standing program five days per week over eight weeks.

Device: Altimate Medical EasyStand Bantam

Interventions

Altimate Medical EasyStand Bantam DEVICE

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

Standing program

Eligibility Criteria

• Age: 9 Years - 9 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of St. Augustine for Health Sciences: lead

Study Sites (1)

University of St. Augustine

San Marcos, California, 92069, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, Principal Investigator, Assistant Professor

Model Details: Single participant case study

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 23, 2022
• Study Start: May 6, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: July 2021, permanently

Locations

US (1)