Quantifying Energetic Demands of Walking for People With Cerebral Palsy

NCT ID: NCT04303078

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2025-06-17

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Children with Cerebral Palsy (Cases)

Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.

Group Type: EXPERIMENTAL

Varying levels of harness support during walking

Intervention Type: OTHER

Participants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels).

Typically Developing Children (Controls)

Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.

Group Type: OTHER

Varying levels of harness support during walking

Intervention Type: OTHER

Participants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Gillette Children's Specialty Healthcare

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Katherine Steele

Associate Professor, Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Steele, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Michael Schwartz, PhD

Role: PRINCIPAL_INVESTIGATOR

Gillette Children's Specialty Healthcare

Locations

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 662304 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21HD104112

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00014591

Identifier Type: -

Identifier Source: org_study_id