Load Experienced While Using a Stander in Children With Cerebral Palsy
February 15, 2016 updated by: Gillette Children's Specialty Healthcare
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- Clinical and Translational Science Institute at University of Minnesota
-
St. Paul, Minnesota, United States, 55101
- Gillette Children's Specialty Healthcare
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Force-measuring platform
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. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone Mineral Density
Time Frame: 12 months
|
Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight (load)experienced by lower extremities
Time Frame: 12 months
|
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.
|
12 months
|
|
Duration of standing treatment session(s) (time)
Time Frame: 12 months
|
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.
|
12 months
|
|
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire
Time Frame: 12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
September 17, 2013
First Submitted That Met QC Criteria
September 24, 2013
First Posted (ESTIMATE)
September 30, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
February 17, 2016
Last Update Submitted That Met QC Criteria
February 15, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15994
- 1308M40341 (OTHER: University of MN Insitutional Review Board)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.