Load Experienced While Using a Stander in Children With Cerebral Palsy
2 other identifiers
interventional
3
1 country
2
Brief Summary
The goal of this project is to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their Bone Mineral Density.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFebruary 17, 2016
February 1, 2016
1.6 years
September 17, 2013
February 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Mineral Density
Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.
12 months
Secondary Outcomes (3)
Weight (load)experienced by lower extremities
12 months
Duration of standing treatment session(s) (time)
12 months
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire
12 months
Study Arms (1)
Force-measuring platform
OTHERA force-measure platform will be placed under each foot of the subject to record the time course of load borne by each of the lower extremities during weight-bearing training in an assisted standing device. Intervention: Assisted Standing Treatment Program. Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of \~9 months.
Interventions
Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of \~9 months. Arm: Force-measuring platform
Eligibility Criteria
You may qualify if:
- \< 18 years old
- Diagnosed with Cerebral Palsy (CP)
- Treated at Gillette Children's Specialty Healthcare
- Gross Motor Function Classification System level of IV or V (non-ambulatory without assistance)
- Participating in a standing program using a stationary assisted standing device
- Parent/Guardian willing and able to give consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gillette Children's Specialty Healthcarelead
- University of Minnesotacollaborator
Study Sites (2)
Clinical and Translational Science Institute at University of Minnesota
Minneapolis, Minnesota, 55414, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Truong, MD
Gillette Children's Specialty Healthcare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 30, 2013
Study Start
February 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
February 17, 2016
Record last verified: 2016-02