Quantifying Energetic Demands of Walking for People With Cerebral Palsy

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Varying levels of harness support during walking

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Schwartz, PhD; Phone Number: 651-229-1745; Email: mschwartz@gillettechildrens.com
• Study Contact Backup: Name: Marissa Thill, MS; Phone Number: 651-229-1748; Email: marissajthill@gillettechildrens.com

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Recruiting
      • Gillette Children's Specialty Healthcare
      • Contact: Marissa Thill, MS
      • Principal Investigator: Michael Schwartz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children with Cerebral Palsy (Cases); Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.	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).
Other: Typically Developing Children (Controls); Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net nondimensional oxygen consumption	Compare net nondimensional oxygen consumption with varying levels of harness support	One-time research visit (1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Passive joint range of motion	Compare passive joint range of motion (degrees) measured by lower extremity physical exam	One-time research visit (15 minutes)
Spasticity	Spasticity measured by Modified Ashworth Scale (0 no increase in tone - 4 rigid in flexion or extension)	One-time research visit (15 minutes)
Selective motor control	Selective motor control (0 patterned movement - 2 complete isolated movement)	One-time research visit (15 minutes)
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)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Gillette Children's Specialty Healthcare
• Investigators: Principal Investigator: Michael Schwartz, PhD, Gillette Children's Specialty Healthcare; Principal Investigator: Katherine Steele, PhD, University of Washington

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Energetic cost
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: STUDY00014591; R21HD104112 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No