Load Experienced While Using a Stander in Children With Cerebral Palsy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Gillette Children's Specialty Healthcare
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier:
NCT01952496
First received: September 17, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Cerebral Palsy
Other: Assisted Standing Treatment Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Load Experienced While Using a Stander in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Gillette Children's Specialty Healthcare:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 5
Study Start Date: February 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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


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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952496

Contacts
Contact: Kari A Williams, MPH 651-325-2316 KariAWilliams@gillettechildrens.com
Contact: Walter Truong, MD 651-578-5197 WTruong@gillettechildrens.com

Locations
United States, Minnesota
Clinical and Translational Science Institute at University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Deborah Hendricks, MPH, RN    612-624-4247    dlhendri@umn.edu   
Contact: Sheila Riggs, DDS, DSMc    612-626-5751    ctsi@umn.edu   
Gillette Children's Specialty Healthcare Not yet recruiting
St. Paul, Minnesota, United States, 55101
Contact: Kari A Williams, MPH    651-325-2315    KariAWilliams@gillettechildrens.com   
Contact: Joyce Trost, PT    651-325-2339    JTrost@gillettechildrens.com   
Principal Investigator: Walter Truong, MD         
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Walter Truong, MD Gillette Children's Specialty Healthcare
  More Information

No publications provided

Responsible Party: Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT01952496     History of Changes
Other Study ID Numbers: 15994, 1308M40341
Study First Received: September 17, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Gillette Children's Specialty Healthcare:
Cerebral Palsy
Non ambulatory
Neuromuscular disability
Children

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014