Load Experienced While Using a Stander in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assisted Standing Treatment Program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Non ambulatory, Neuromuscular disability, Children
Eligibility Criteria
Inclusion Criteria:
- < 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
Exclusion Criteria:
None
Sites / Locations
- Clinical and Translational Science Institute at University of Minnesota
- Gillette Children's Specialty Healthcare
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Force-measuring platform
Arm Description
A 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.
Outcomes
Primary Outcome Measures
Bone Mineral Density
Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.
Secondary Outcome Measures
Weight (load)experienced by lower extremities
A platform will measure the magnitude 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.
Duration of standing treatment session(s) (time)
A platform will measure the 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.
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire
The CPCHILD© measures caregivers' perspectives on the health status, comfort, well being, functional abilities and ease of caregiving of children with severe developmental disabilities. It was developed to measure the effectiveness of interventions intended to improve or preserve these outcomes for children with severe disabilities, including non-ambulant children with severe cerebral palsy, and traumatic or other acquired brain injuries. This will help determine if care-givers perception of health status changes with changes in standing magnitude and duration.
Full Information
NCT ID
NCT01952496
First Posted
September 17, 2013
Last Updated
February 15, 2016
Sponsor
Gillette Children's Specialty Healthcare
Collaborators
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01952496
Brief Title
Load Experienced While Using a Stander in Children With Cerebral Palsy
Official Title
Load Experienced While Using a Stander in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gillette Children's Specialty Healthcare
Collaborators
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Non-ambulatory children with a neuromuscular disability are at significant risk for poor bone health as reflected by low bone mineral density (BMD) and increased propensity to fracture. In large part, this is due to abnormally low levels of load experienced by the skeleton. A common approach for increasing BMD is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this typically takes the form of using an assisted standing device to enable the child to spend time in a standing position so that their lower limbs can experience some degree of body weight. Some of these physical interventions result in varying degrees of improvement in BMD, and some do not. This lack of clarity in outcomes may result from a failure to objectively measure the magnitude and duration of the load experienced by the lower extremities. A lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight due to load-sharing with the assistive device, or to an inadequate duration of standing time. The goal of this project will be 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 BMD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Non ambulatory, Neuromuscular disability, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Force-measuring platform
Arm Type
Other
Arm Description
A 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.
Intervention Type
Other
Intervention Name(s)
Assisted Standing Treatment Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Bone Mineral Density
Description
Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight (load)experienced by lower extremities
Description
A platform will measure the magnitude 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.
Time Frame
12 months
Title
Duration of standing treatment session(s) (time)
Description
A platform will measure the 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.
Time Frame
12 months
Title
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire
Description
The CPCHILD© measures caregivers' perspectives on the health status, comfort, well being, functional abilities and ease of caregiving of children with severe developmental disabilities. It was developed to measure the effectiveness of interventions intended to improve or preserve these outcomes for children with severe disabilities, including non-ambulant children with severe cerebral palsy, and traumatic or other acquired brain injuries. This will help determine if care-givers perception of health status changes with changes in standing magnitude and duration.
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
< 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
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Truong, MD
Organizational Affiliation
Gillette Children's Specialty Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Science Institute at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Gillette Children's Specialty Healthcare
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Load Experienced While Using a Stander in Children With Cerebral Palsy
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