Cerebral PalsyNCT04957277
Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy
A study testing load modulation in people with Cerebral Palsy and Bilateral Cerebral Palsy, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks. Read more about this study
- Who is it for?
- Ages 5 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Bilateral Cerebral Palsy, Diplegic Cerebral Palsy
- What is being tested?
- load modulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.
Read the 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.
- Being tested
- load modulation
- Keywords
- Cerebral Palsy, Bilateral Cerebral Palsy, Gait, Stepping, Stairs, Biomechanics, Neuroscience
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
load modulationOther
Adding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: load modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint biomechanics (support moment)
Sum of the joint kinetics from the hip, knee and ankle, termed the "support moment" and measured in Nm.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
EMG data will be identified for underlying muscles of the hip during the stance phases of the task.
Measured: 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)
EMG data will be identified for underlying muscles of the knee during the stance phases of the task.
Measured: 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)
EMG data will be identified for underlying muscles of the ankle during the stance phases of the task.
Measured: At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start19 May 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants are exposed to all conditions in a randomized order.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Moulton, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957277
- Sponsor's protocol ID
- STU00214804
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data files underlying publications will be shared
Publications
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.
PubMed 19627331Fowler 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.
PubMed 20089048Novak 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.
PubMed 21036615Lepage 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.
PubMed 9597060
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04957277
- Acronym / sponsor ID
- STU00214804
- Keywords
- Cerebral Palsy, Bilateral Cerebral Palsy, Gait, Stepping, Stairs, Biomechanics, Neuroscience
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are exposed to all conditions in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| load modulation | Experimental | Other: load modulationParticipants will experience different body weight loading conditions - with body weight added by a weighted vest or removed using the ZeroG overhead harness. |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| load modulationAdding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW | Other | load modulation |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 19627331Rose 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.
- Background: PubMed 20089048Fowler 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.
- Background: PubMed 21036615Novak 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.
- Background: PubMed 9597060Lepage 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.
- Individual participant dataSharing planned: Yes. Raw data files underlying publications will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing load modulation in people with Cerebral Palsy and Bilateral Cerebral Palsy, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04957277, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.