Clinical trial NCT04957277: Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy
Official title: Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Bilateral Cerebral Palsy
Diplegic Cerebral Palsy
Keywords: Cerebral Palsy
Bilateral Cerebral Palsy
Gait
Stepping
Stairs
Biomechanics
Neuroscience
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants are exposed to all conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Joint biomechanics (support moment)
timeFrame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
measure: Joint biomechanics (hip)
timeFrame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
measure: Joint biomechanics (knee)
timeFrame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
measure: Joint biomechanics (ankle)
timeFrame: 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:
measure: Muscle activations (hip)
timeFrame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
measure: Muscle activations (knee)
timeFrame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
measure: Muscle activations (ankle)
timeFrame: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.