Quantifying Energetic Demands of Walking for People With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Quantifying Energetic Demands of Walking for People With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04303078
• Other study ID #: STUDY00014591
• Secondary ID: R21HD104112
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: Michael Schwartz, PhD
• Phone: 651-229-1745
• Email: mschwartz[@]gillettechildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Varying levels of harness support during walking
Participants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels).

Locations

Country	Name	City	State
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gillette Children's Specialty Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (1)

Campbell J, Ball J. Energetics of walking in cerebral palsy. Orthop Clin North Am. 1978 Apr;9(2):374-7. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net nondimensional oxygen consumption	Compare net nondimensional oxygen consumption with varying levels of harness support	One-time research visit (1 hour)
Secondary	Three-dimensional gait kinematics	Three-dimensional gait kinematics to estimate body position and orientation, including trunk and lower limb	One-time research visit (1 hour)
Secondary	Three-dimensional gait kinetics	Three-dimensional gait kinetics to estimate joint moments (Nm/kg) of the hip, knee, and ankle	One-time research visit (1 hour)
Secondary	Passive joint range of motion	Compare passive joint range of motion (degrees) measured by lower extremity physical exam	One-time research visit (15 minutes)
Secondary	Spasticity	Spasticity measured by Modified Ashworth Scale (0 no increase in tone - 4 rigid in flexion or extension)	One-time research visit (15 minutes)
Secondary	Selective motor control	Selective motor control (0 patterned movement - 2 complete isolated movement)	One-time research visit (15 minutes)
Secondary	Lower extremity strength	Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)	One-time research visit (15 minutes)