Quantifying Energetic Demands of Walking for People With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Varying levels of harness support during walking
Sponsored by
About this trial
This is an interventional basic science trial for Cerebral Palsy focused on measuring Energetic cost
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
Sites / Locations
- Gillette Children's Specialty HealthcareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Children with Cerebral Palsy (Cases)
Typically Developing Children (Controls)
Arm Description
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
Outcomes
Primary Outcome Measures
Net nondimensional oxygen consumption
Compare net nondimensional oxygen consumption with varying levels of harness support
Secondary Outcome Measures
Three-dimensional gait kinematics
Three-dimensional gait kinematics to estimate body position and orientation, including trunk and lower limb
Three-dimensional gait kinetics
Three-dimensional gait kinetics to estimate joint moments (Nm/kg) of the hip, knee, and ankle
Passive joint range of motion
Compare passive joint range of motion (degrees) measured by lower extremity physical exam
Spasticity
Spasticity measured by Modified Ashworth Scale (0 no increase in tone - 4 rigid in flexion or extension)
Selective motor control
Selective motor control (0 patterned movement - 2 complete isolated movement)
Lower extremity strength
Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)
Full Information
NCT ID
NCT04303078
First Posted
February 21, 2020
Last Updated
October 23, 2023
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gillette Children's Specialty Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04303078
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gillette Children's Specialty Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Energetic cost
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children with Cerebral Palsy (Cases)
Arm Type
Experimental
Arm Description
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
Arm Title
Typically Developing Children (Controls)
Arm Type
Other
Arm Description
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
Intervention Type
Other
Intervention Name(s)
Varying levels of harness support during walking
Intervention Description
Participants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels).
Primary Outcome Measure Information:
Title
Net nondimensional oxygen consumption
Description
Compare net nondimensional oxygen consumption with varying levels of harness support
Time Frame
One-time research visit (1 hour)
Secondary Outcome Measure Information:
Title
Three-dimensional gait kinematics
Description
Three-dimensional gait kinematics to estimate body position and orientation, including trunk and lower limb
Time Frame
One-time research visit (1 hour)
Title
Three-dimensional gait kinetics
Description
Three-dimensional gait kinetics to estimate joint moments (Nm/kg) of the hip, knee, and ankle
Time Frame
One-time research visit (1 hour)
Title
Passive joint range of motion
Description
Compare passive joint range of motion (degrees) measured by lower extremity physical exam
Time Frame
One-time research visit (15 minutes)
Title
Spasticity
Description
Spasticity measured by Modified Ashworth Scale (0 no increase in tone - 4 rigid in flexion or extension)
Time Frame
One-time research visit (15 minutes)
Title
Selective motor control
Description
Selective motor control (0 patterned movement - 2 complete isolated movement)
Time Frame
One-time research visit (15 minutes)
Title
Lower extremity strength
Description
Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)
Time Frame
One-time research visit (15 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Schwartz, PhD
Phone
651-229-1745
Email
mschwartz@gillettechildrens.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa Thill, MS
Phone
651-229-1748
Email
marissajthill@gillettechildrens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Steele, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Schwartz, PhD
Organizational Affiliation
Gillette Children's Specialty Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gillette Children's Specialty Healthcare
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marissa Thill, MS
First Name & Middle Initial & Last Name & Degree
Michael Schwartz, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
662304
Citation
Campbell J, Ball J. Energetics of walking in cerebral palsy. Orthop Clin North Am. 1978 Apr;9(2):374-7. No abstract available.
Results Reference
background
Learn more about this trial
Quantifying Energetic Demands of Walking for People With Cerebral Palsy
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