Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

March 13, 2024 updated by: Theresa Moulton, Northwestern University
The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Individuals with bilateral cerebral palsy (BCP) sustain a neonatal brain injury that leads to altered neuromuscular control to the lower limbs. One commonly observed motor impairment from this altered control is loss of selective voluntary motor control (SVMC), defined as the ability to independently move the joints intentionally. Loss of SVMC typically manifests as knee and ankle joint impairment and abnormal coupling between the hip adductors and lower limb extensors. This can make stepping up or down a curb or stair challenging, but quantitative investigation in these closed-chain activities has been limited. This is especially important as performance in stair-climbing is associated with limitations to overall mobility and community participation in cerebral palsy.

The overall aim of this proposal is to investigate the altered neuromuscular control that challenges stair walking in individuals with BCP. Participants who consent to the study will be instructed to perform multiple step-ups and step-downs on a single raised platform. The parameters of the stepping task may change by adding weight to the body or subtracting weight from the body. Using standard gait analysis techniques, biomechanical metrics such as joint kinematics and kinetics will be analyzed.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • aged 5 years to 19 years
  • typically developing with no diagnosed medical conditions that affect movement, OR with a diagnosis of bilateral cerebral palsy (including diplegia, tetraplegia, and quadriplegia) where the lower limbs are more affected than the upper limbs
  • ability to independently step up, with or without assistive devices.

Exclusion Criteria:

  • lower limb surgery in the past year
  • botulinum toxin injections to the lower limb muscles in the past 6 months
  • cognitive dysfunction that would make following directions difficult
  • comorbidities that would make participation unsafe.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: load modulation
Participants will experience different body weight loading conditions - with body weight added by a weighted vest or removed using the ZeroG overhead harness.
Other: load modulation
Adding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint biomechanics (support moment)
Time Frame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Sum of the joint kinetics from the hip, knee and ankle, termed the "support moment" and measured in Nm.
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Joint biomechanics (hip)
Time Frame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
hip torque (measured in Nm) will be identified for the hip, knee, and ankle during the duration of the task.
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Joint biomechanics (knee)
Time Frame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Knee angle (between the thigh and shank measured in degrees) will be identified during the duration of the task.
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Joint biomechanics (ankle)
Time Frame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Ankle angle (between the shank and foot measured in degrees) will be identified during the duration of the task.
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle activations (hip)
Time Frame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
EMG data will be identified for underlying muscles of the hip during the stance phases of the task.
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Muscle activations (knee)
Time Frame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
EMG data will be identified for underlying muscles of the knee during the stance phases of the task.
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Muscle activations (ankle)
Time Frame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
EMG data will be identified for underlying muscles of the ankle during the stance phases of the task.
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00214804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw data files underlying publications will be shared

IPD Sharing Time Frame

Upon publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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