Impact of a Standing Program in a Child With Spina Bifida: A Case Report
Primary Purpose
Spina Bifida With Hydrocephalus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Altimate Medical EasyStand Bantam
Sponsored by
About this trial
This is an interventional treatment trial for Spina Bifida With Hydrocephalus
Eligibility Criteria
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
Sites / Locations
- University of St. Augustine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standing program
Arm Description
The child completes a 60-minute home standing program five days per week over eight weeks.
Outcomes
Primary Outcome Measures
Goniometric measurements
A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Goniometric measurements
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)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05251740
First Posted
January 20, 2022
Last Updated
February 11, 2022
Sponsor
University of St. Augustine for Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05251740
Brief Title
Impact of a Standing Program in a Child With Spina Bifida: A Case Report
Official Title
Impact of a Standing Program in a Child With Spina Bifida: A Case Report
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of St. Augustine for Health Sciences
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida With Hydrocephalus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single participant case study
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standing program
Arm Type
Experimental
Arm Description
The child completes a 60-minute home standing program five days per week over eight weeks.
Intervention Type
Device
Intervention Name(s)
Altimate Medical EasyStand Bantam
Intervention Description
The child will stand in the device for 60 min per day, 5 days per week for 2 months.
Primary Outcome Measure Information:
Title
Goniometric measurements
Description
A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Time Frame
At 0 weeks
Title
Goniometric measurements
Description
A universal goniometer will be used to measure the child's hip and knee joint passive ranges of motion (PROM).
Time Frame
At 8 weeks
Title
Pediatric Neuromuscular Recovery Scale (Peds NRS)
Description
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.
Time Frame
At 0 weeks
Title
Pediatric Neuromuscular Recovery Scale (Peds NRS)
Description
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.
Time Frame
At 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of St. Augustine
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to include goniometric and Peds NRS results and describe the protocol used
IPD Sharing Time Frame
July 2021, permanently
Learn more about this trial
Impact of a Standing Program in a Child With Spina Bifida: A Case Report
We'll reach out to this number within 24 hrs