Cerebral PalsyNCT04303078
Quantifying Energetic Demands of Walking for People With Cerebral Palsy
A study testing Varying levels of harness support during walking in people with Cerebral Palsy, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to examine the underlying mechanisms that contribute to high energy costs for people with cerebral palsy (CP) as they walk. The investigators will characterize the cost landscape of children with CP, quantifying the magnitude of cost (net nondimensional oxygen consumption) associated with… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Varying levels of harness support during walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 17 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-17 years old
- Diagnosed with bilateral cerebral palsy
- Gross Motor Function Classification System II
- No surgery within the last 9 months
- No current baclofen pump or explantation in the last 2 months
- No botulinum toxin or phenol injections in the last 2 months
Show all 12Show fewer
- Had a prior gait and motion analysis at Gillette Children's Specialty Healthcare
- Participant and caregiver able to speak and read English
- Ability to follow instructions
- 8-17 years old
- Participant and caregiver able to speak and read English
- Ability to follow instructions
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
About this study
The purpose of this study is to examine the underlying mechanisms that contribute to high energy costs for people with cerebral palsy (CP) as they walk.
The investigators will characterize the cost landscape of children with CP, quantifying the magnitude of cost (net nondimensional oxygen consumption) associated with walking and common sub-tasks of walking, such as supporting and stabilizing the body.
Read the detailed description
Children with CP use large amounts of energy to walk and move, leading to fatigue and limiting participation. For people with CP the energetic cost of walking is on average over two times higher than typically-developing (TD) peers. This means that for people with CP, walking is as tiring as jogging or climbing stairs. An energetic cost of this magnitude restricts activities of daily living (ADL) and causes exhaustion.
While the investigators and many others have sought to reduce these energetic costs through surgical interventions, rehabilitation, orthotics, or other assistive devices, these strategies have failed to result in meaningful reductions in energy. To design strategies that successfully reduce walking costs, the investigators must first understand the underlying mechanisms contributing to elevated cost in people with CP. This basic-science research will provide the foundation to create evidence-based strategies to decrease energy costs, minimize fatigue, and increase quality of life for people with CP and other neurologic injuries.
- Conditions
- Cerebral Palsy
- Being tested
- Varying levels of harness support during walking
- Keywords
- Energetic cost
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varying levels of harness support during walkingOther
Participants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels).
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Palsy (Cases) | Experimental | Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy. Receives: Other: Varying levels of harness support during walking |
| Typically Developing Children (Controls) | Other | Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition. Receives: Other: Varying levels of harness support during walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Nondimensional Oxygen Cost
Steady-state net nondimensional oxygen consumption while walking on a treadmill. Percent change in oxygen consumption was evaluated between baseline without support and with vertical and lateral support.
Measured: Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)
Secondary outcomes (7)
Three-dimensional Gait Kinematics (Baseline)
Five features describing kinematics during gait in the harness system without vertical or lateral support collected from marker-based motion capture. Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) median pelvic tilt during the stance phase, (2) peak hip extension, (3) peak knee extension, (4) peak ankle plantarflexion, and (5) the foot progression angle relative to fore-aft direction.
Measured: Initial trial without support (5-minutes)
Three-dimensional Gait Kinematics (Support)
Five features describing kinematics during gait in the harness system with vertical and lateral support. The features include (1) median pelvic tilt during the stance phase, (2) peak hip extension, (3) peak knee extension, (4) peak ankle plantarflexion, and (5) the foot progression angle relative to fore-aft direction.
Measured: Trial with maximum support (5-minutes)
Three-dimensional Gait Kinetics (Baseline)
Three features describing kinetics during gait in the harness system without vertical or lateral support collected from marker-based motion capture and instrumented treadmill for ground reaction forces. Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) peak hip extensor moment, (2) peak knee extensor moment, and (3) peak ankle plantarflexor moment.
Measured: Initial trial without support (5-minutes)
Three-dimensional Gait Kinetics (Support)
Three features describing kinetics during gait in the harness system with vertical and lateral support. . Since the harness system differed between vertical and lateral support, baseline kinematics are reported separately for each system in the rows below. The features include (1) peak hip extensor moment, (2) peak knee extensor moment, and (3) peak ankle plantarflexor moment.
Measured: Trial with maximum support (5-minutes)
Passive Joint Range of Motion
Compare passive joint range of motion (degrees) measured by lower extremity physical exam
Measured: One-time research visit (15 minutes)
Selective Motor Control
Selective motor control (0 patterned movement - 2 complete isolated movement)
Measured: One-time research visit (15 minutes)
Lower Extremity Strength
Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)
Measured: One-time research visit (15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start15 Aug 2023
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 University of WashingtonThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gillette Children's Specialty Healthcare
- Responsible party
- Principal investigator, Katherine Steele, University of Washington
- Investigators
- Katherine Steele, PhD, Principal investigator, University of WashingtonMichael Schwartz, PhD, Principal investigator, Gillette Children's Specialty Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303078
- Sponsor's protocol ID
- STUDY00014591
- Other IDs
- R21HD104112
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2020
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campbell J, Ball J. Energetics of walking in cerebral palsy. Orthop Clin North Am. 1978 Apr;9(2):374-7. No abstract available.
PubMed 662304
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Energetic Demands of Walking for People With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04303078
- Acronym / sponsor ID
- STUDY00014591
- Conditions
- Cerebral Palsy
- Keywords
- Energetic cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gillette Children's Specialty Healthcare
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Posted 27 Jan 2026
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 examine the underlying mechanisms that contribute to high energy costs for people with cerebral palsy (CP) as they walk.
The investigators will characterize the cost landscape of children with CP, quantifying the magnitude of cost (net nondimensional oxygen consumption) associated with walking and common sub-tasks of walking, such as supporting and stabilizing the body.
Detailed description
Children with CP use large amounts of energy to walk and move, leading to fatigue and limiting participation. For people with CP the energetic cost of walking is on average over two times higher than typically-developing (TD) peers. This means that for people with CP, walking is as tiring as jogging or climbing stairs. An energetic cost of this magnitude restricts activities of daily living (ADL) and causes exhaustion.
While the investigators and many others have sought to reduce these energetic costs through surgical interventions, rehabilitation, orthotics, or other assistive devices, these strategies have failed to result in meaningful reductions in energy. To design strategies that successfully reduce walking costs, the investigators must first understand the underlying mechanisms contributing to elevated cost in people with CP. This basic-science research will provide the foundation to create evidence-based strategies to decrease energy costs, minimize fatigue, and increase quality of life for people with CP and other neurologic injuries.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy (Cases) | Experimental | Other: Varying levels of harness support during walkingChildren meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy. |
| Typically Developing Children (Controls) | Other | Other: Varying levels of harness support during walkingChildren meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 8-17 years old
- Diagnosed with bilateral cerebral palsy
- Gross Motor Function Classification System II
- No surgery within the last 9 months
- No current baclofen pump or explantation in the last 2 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Varying levels of harness support during walkingParticipants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels). | Other | Children with Cerebral Palsy (Cases), Typically Developing Children (Controls) |
Primary outcome
Net Nondimensional Oxygen Cost
Time frame: Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)
Steady-state net nondimensional oxygen consumption while walking on a treadmill. Percent change in oxygen consumption was evaluated between baseline without support and with vertical and lateral support.
7 secondary outcomes
Three-dimensional Gait Kinematics (Baseline)
Time frame: Initial trial without support (5-minutes)
Three-dimensional Gait Kinematics (Support)
Time frame: Trial with maximum support (5-minutes)
Three-dimensional Gait Kinetics (Baseline)
Time frame: Initial trial without support (5-minutes)
Three-dimensional Gait Kinetics (Support)
Time frame: Trial with maximum support (5-minutes)
Passive Joint Range of Motion
Time frame: One-time research visit (15 minutes)
Selective Motor Control
Time frame: One-time research visit (15 minutes)
Lower Extremity Strength
Time frame: One-time research visit (15 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 662304Campbell J, Ball J. Energetics of walking in cerebral palsy. Orthop Clin North Am. 1978 Apr;9(2):374-7. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Katherine Steele, PhD principal investigator
University of Washington
Michael Schwartz, PhD principal investigator
Gillette Children's Specialty Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varying levels of harness support during walking in people with Cerebral Palsy, run by University of Washington 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 12 inclusion and 0 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: finished, as of the sponsor's last update on 27 Jan 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?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Net Nondimensional Oxygen Cost (time frame: Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)). 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 NCT04303078, which also lists 1 linked publication.
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 27 Jan 2026.