NCT04303078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
3.4 years until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

February 21, 2020

Results QC Date

November 3, 2025

Last Update Submit

January 8, 2026

Conditions

Cerebral Palsy

Keywords

Energetic cost

Outcome Measures

Primary Outcomes (1)

  • Net Nondimensional Oxygen Cost

    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.

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

Secondary Outcomes (7)

  • Three-dimensional Gait Kinematics (Baseline)

    Initial trial without support (5-minutes)

  • Three-dimensional Gait Kinematics (Support)

    Trial with maximum support (5-minutes)

  • Three-dimensional Gait Kinetics (Baseline)

    Initial trial without support (5-minutes)

  • Three-dimensional Gait Kinetics (Support)

    Trial with maximum support (5-minutes)

  • Passive Joint Range of Motion

    One-time research visit (15 minutes)

  • +2 more secondary outcomes

Study Arms (2)

Children with Cerebral Palsy (Cases)

EXPERIMENTAL

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

Other: Varying levels of harness support during walking

Typically Developing Children (Controls)

OTHER

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

Other: Varying levels of harness support during walking

Interventions

Varying levels of harness support during walkingOTHER

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

Children with Cerebral Palsy (Cases)Typically Developing Children (Controls)

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related 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.

    PMID: 662304BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Katherine Steele
Organization
University of Washington
kmsteele@uw.edu
206-685-2390

Study Officials

  • Katherine Steele, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Michael Schwartz, PhD

    Gillette Children's Specialty Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Engineering

Study Record Dates

First Submitted

February 21, 2020

First Posted

March 10, 2020

Study Start

August 15, 2023

Primary Completion

June 17, 2025

Study Completion

June 17, 2025

Last Updated

January 27, 2026

Results First Posted

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)