Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04957277
• Other study ID #: STU00214804
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy
• Paralysis

Intervention

Other:
• load modulation
Adding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Muscle activations (hip)	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.
Secondary	Muscle activations (knee)	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.
Secondary	Muscle activations (ankle)	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.