Clinical trial NCT01952496: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Non ambulatory
Neuromuscular disability
Children
Lead sponsor: Gillette Children's Specialty Healthcare
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2013-09-30
Enrollment: 3
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 12 months
Secondary outcomes:
measure: Weight (load)experienced by lower extremities
timeFrame: 12 months
measure: Duration of standing treatment session(s) (time)
timeFrame: 12 months
measure: Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Science Institute at University of Minnesota
state: Minnesota
city: St. Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: Gillette Children's Specialty Healthcare
name: Walter Truong, MD
role: PRINCIPAL_INVESTIGATOR
References: