Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

NCT04957277 | Active Not Recruiting

• 1 other identifier: STU00214804
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy; Bilateral Cerebral Palsy; Diplegic Cerebral Palsy

Keywords

Cerebral Palsy; Bilateral Cerebral Palsy; Gait; Stepping; Stairs; Biomechanics; Neuroscience

Outcome Measures

Primary Outcomes (4)

• Joint biomechanics (support moment)

  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)

  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)

  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)

  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 Outcomes (3)

• Muscle activations (hip)

  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)

  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)

  At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.

Study Arms (1)

load modulation

EXPERIMENTAL

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

Interventions

load modulation OTHER

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

load modulation

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• 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.

  PMID: 19627331 BACKGROUND

• 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.

  PMID: 20089048 BACKGROUND

• 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.

  PMID: 21036615 BACKGROUND

• 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.

  PMID: 9597060 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants are exposed to all conditions in a randomized order.

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 12, 2021
• Study Start: May 19, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication

Locations

US (1)