Clinical trial NCT04303078: Quantifying Energetic Demands of Walking for People With Cerebral Palsy
Official title: Quantifying Energetic Demands of Walking for People With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Energetic cost
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Gillette Children's Specialty Healthcare
First posted: 2020-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the underlying mechanisms that contribute to high energy costs for people with cerebral palsy (CP) as they walk.

The investigators will characterize the cost landscape of children with CP, quantifying the magnitude of cost (net nondimensional oxygen consumption) associated with walking and common sub-tasks of walking, such as supporting and stabilizing the body.

Detailed description: Children with CP use large amounts of energy to walk and move, leading to fatigue and limiting participation. For people with CP the energetic cost of walking is on average over two times higher than typically-developing (TD) peers. This means that for people with CP, walking is as tiring as jogging or climbing stairs. An energetic cost of this magnitude restricts activities of daily living (ADL) and causes exhaustion.

While the investigators and many others have sought to reduce these energetic costs through surgical interventions, rehabilitation, orthotics, or other assistive devices, these strategies have failed to result in meaningful reductions in energy. To design strategies that successfully reduce walking costs, the investigators must first understand the underlying mechanisms contributing to elevated cost in people with CP. This basic-science research will provide the foundation to create evidence-based strategies to decrease energy costs, minimize fatigue, and increase quality of life for people with CP and other neurologic injuries.

Eligibility criteria: Inclusion Criteria for Cases:

* 8-17 years old
* Diagnosed with bilateral cerebral palsy
* Gross Motor Function Classification System II
* No surgery within the last 9 months
* No current baclofen pump or explantation in the last 2 months
* No botulinum toxin or phenol injections in the last 2 months
* Had a prior gait and motion analysis at Gillette Children's Specialty Healthcare
* Participant and caregiver able to speak and read English
* Ability to follow instructions

Inclusion Criteria for Controls:

* 8-17 years old
* Participant and caregiver able to speak and read English
* Ability to follow instructions

Primary outcomes:
measure: Net nondimensional oxygen consumption
timeFrame: One-time research visit (1 hour)
Secondary outcomes:
measure: Three-dimensional gait kinematics
timeFrame: One-time research visit (1 hour)
measure: Three-dimensional gait kinetics
timeFrame: One-time research visit (1 hour)
measure: Passive joint range of motion
timeFrame: One-time research visit (15 minutes)
measure: Spasticity
timeFrame: One-time research visit (15 minutes)
measure: Selective motor control
timeFrame: One-time research visit (15 minutes)
measure: Lower extremity strength
timeFrame: One-time research visit (15 minutes)
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: University of Washington
name: Katherine Steele, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gillette Children's Specialty Healthcare
name: Michael Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell J, Ball J. Energetics of walking in cerebral palsy. Orthop Clin North Am. 1978 Apr;9(2):374-7. No abstract available.