Load Experienced While Using a Stander in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Load Experienced While Using a Stander in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952496
• Other study ID #: 15994
• Secondary ID: 1308M40341
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: February 15, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Gillette Children's Specialty Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

1. < 18 years old

2. Diagnosed with Cerebral Palsy (CP)

3. Treated at Gillette Children's Specialty Healthcare

4. Gross Motor Function Classification System level of IV or V (non-ambulatory without assistance)

5. Participating in a standing program using a stationary assisted standing device

6. Parent/Guardian willing and able to give consent

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• 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. Arm: Force-measuring platform

Locations

Country	Name	City	State
United States	Clinical and Translational Science Institute at University of Minnesota	Minneapolis	Minnesota
United States	Gillette Children's Specialty Healthcare	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Gillette Children's Specialty Healthcare	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	12 months	No
Secondary	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.	12 months	No
Secondary	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.	12 months	No