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

Sponsor
University of St. Augustine for Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05251740
Collaborator
(none)
1
1
1
2.1
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Altimate Medical EasyStand Bantam
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single participant case studySingle participant case study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of a Standing Program in a Child With Spina Bifida: A Case Report
Actual Study Start Date :
May 6, 2021
Actual Primary Completion Date :
Jul 8, 2021
Actual Study Completion Date :
Jul 8, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Goniometric measurements [At 0 weeks]

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

  2. Goniometric measurements [At 8 weeks]

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

  3. Pediatric Neuromuscular Recovery Scale (Peds NRS) [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.

  4. Pediatric Neuromuscular Recovery Scale (Peds NRS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 9 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of St. Augustine San Marcos California United States 92069

Sponsors and Collaborators

  • University of St. Augustine for Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marianne Hanover, PT, DPT, Physical Therapist, Principal Investigator, Assistant Professor, University of St. Augustine for Health Sciences
ClinicalTrials.gov Identifier:
NCT05251740
Other Study ID Numbers:
  • 0329-21
First Posted:
Feb 23, 2022
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022