Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

NCT ID: NCT04957277

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2025-06-30

Brief Summary

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The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.

Detailed Description

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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.

Conditions

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Cerebral Palsy Bilateral Cerebral Palsy Diplegic Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants are exposed to all conditions in a randomized order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

load modulation

Intervention Type OTHER

Adding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW

Interventions

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load modulation

Adding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Theresa Moulton

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Rose J. Selective motor control in spastic cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):578-9. doi: 10.1111/j.1469-8749.2009.03401.x. No abstract available.

Reference Type BACKGROUND
PMID: 19627331 (View on PubMed)

Fowler EG, Staudt LA, Greenberg MB. Lower-extremity selective voluntary motor control in patients with spastic cerebral palsy: increased distal motor impairment. Dev Med Child Neurol. 2010 Mar;52(3):264-9. doi: 10.1111/j.1469-8749.2009.03586.x.

Reference Type BACKGROUND
PMID: 20089048 (View on PubMed)

Novak AC, Brouwer B. Sagittal and frontal lower limb joint moments during stair ascent and descent in young and older adults. Gait Posture. 2011 Jan;33(1):54-60. doi: 10.1016/j.gaitpost.2010.09.024. Epub 2010 Oct 30.

Reference Type BACKGROUND
PMID: 21036615 (View on PubMed)

Lepage C, Noreau L, Bernard PM. Association between characteristics of locomotion and accomplishment of life habits in children with cerebral palsy. Phys Ther. 1998 May;78(5):458-69. doi: 10.1093/ptj/78.5.458.

Reference Type BACKGROUND
PMID: 9597060 (View on PubMed)

Other Identifiers

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STU00214804

Identifier Type: -

Identifier Source: org_study_id

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