Skip to main content
OpenTrials
Completed

NCT Number: NCT04303078

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varying levels of harness support during walking

Other

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

Primary outcomes

  1. Net Nondimensional Oxygen Cost

    Time frame: Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)

    Steady-state net nondimensional oxygen consumption while walking on a treadmill. Percent change in oxygen consumption was evaluated between baseline without support and with vertical and lateral support.

Secondary outcomes

  1. Three-dimensional Gait Kinematics (Baseline)

    Time frame: Initial trial without support (5-minutes)

    Five features describing kinematics during gait in the harness system without vertical or lateral support collected from marker-based motion capture. Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) median pelvic tilt during the stance phase, (2) peak hip extension, (3) peak knee extension, (4) peak ankle plantarflexion, and (5) the foot progression angle relative to fore-aft direction.

  2. Three-dimensional Gait Kinematics (Support)

    Time frame: Trial with maximum support (5-minutes)

    Five features describing kinematics during gait in the harness system with vertical and lateral support. The features include (1) median pelvic tilt during the stance phase, (2) peak hip extension, (3) peak knee extension, (4) peak ankle plantarflexion, and (5) the foot progression angle relative to fore-aft direction.

  3. Three-dimensional Gait Kinetics (Baseline)

    Time frame: Initial trial without support (5-minutes)

    Three features describing kinetics during gait in the harness system without vertical or lateral support collected from marker-based motion capture and instrumented treadmill for ground reaction forces. Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) peak hip extensor moment, (2) peak knee extensor moment, and (3) peak ankle plantarflexor moment.

  4. Three-dimensional Gait Kinetics (Support)

    Time frame: Trial with maximum support (5-minutes)

    Three features describing kinetics during gait in the harness system with vertical and lateral support. . Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) peak hip extensor moment, (2) peak knee extensor moment, and (3) peak ankle plantarflexor moment.

  5. Passive Joint Range of Motion

    Time frame: One-time research visit (15 minutes)

    Compare passive joint range of motion (degrees) measured by lower extremity physical exam

  6. Selective Motor Control

    Time frame: One-time research visit (15 minutes)

    Selective motor control (0 patterned movement - 2 complete isolated movement)

  7. Lower Extremity Strength

    Time frame: One-time research visit (15 minutes)

    Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Gillette Children's Specialty Healthcare

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2020
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.