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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD104112 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Gillette Children's Specialty Healthcare | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with Cerebral Palsy (Cases) | Experimental | Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy. |
|
| Typically Developing Children (Controls) | Other | Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varying levels of harness support during walking | Other | Participants will complete a standard gait and motion analysis at varying levels of harness support and stabilization (low, moderate, and high levels). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for Cases:
Inclusion Criteria for Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Steele, PhD | University of Washington | Principal Investigator |
| Michael Schwartz, PhD | Gillette Children's Specialty Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 662304 | Background | Campbell J, Ball J. Energetics of walking in cerebral palsy. Orthop Clin North Am. 1978 Apr;9(2):374-7. No abstract available. |
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Participants were recruited through Gillette Children's via electronic medical record search, flyers, social media postings, and word of mouth at local clinics and community organizations. Recruitment started in the Summer of 2023, after a delay due to a facility flood, and was completed in the Summer of 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Children With Cerebral Palsy (Cases) | Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy. |
| FG001 | Typically Developing Children (Controls) | Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The sample size was based on differences in costs between cerebral palsy and typically-developing groups from retrospective analyses and literature. The statistical plan was designed to detect a similar difference in cost between groups with a 3:1 allocation with alpha = 0.05 and 90% power, with a required sample size of 21 children with CP and 7 typically-developing peers stratified by age and sex.
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| ID | Title | Description |
|---|---|---|
| BG000 | Children With Cerebral Palsy (Cases) | Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy. |
| BG001 | Typically Developing Children (Controls) | Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant with cerebral palsy consented, but did not participate in the protocol. Issues with the system precluded inclusion of 9 additional participants with cerebral palsy for the lateral support analysis. | Posted | Mean | Standard Deviation | Percent change relative to baseline | Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes) |
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During a single visit, up to 3 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children With Cerebral Palsy (Cases) | Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Steele | University of Washington | 206-685-2390 | kmsteele@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2025 | Nov 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. | 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. | 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. | Trial with maximum support (5-minutes) |
| Passive Joint Range of Motion | Compare passive joint range of motion (degrees) measured by lower extremity physical exam | One-time research visit (15 minutes) |
| Selective Motor Control | Selective motor control (0 patterned movement - 2 complete isolated movement) | 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) | One-time research visit (15 minutes) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Typically Developing Children (Controls) |
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition. |
|
|
| Secondary | 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. | One participant with cerebral palsy consented, but did not participate in the protocol. Issues with the system precluded inclusion of 9 additional participants with cerebral palsy for the lateral support analysis. | Posted | Mean | Standard Deviation | Degrees | Initial trial without support (5-minutes) |
|
|
|
| Secondary | 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. | One participant with cerebral palsy consented, but did not participate in the protocol. Issues with the system precluded inclusion of 9 additional participants with cerebral palsy for the lateral support analysis. | Posted | Mean | Standard Deviation | Degrees | Trial with maximum support (5-minutes) |
|
|
|
| Secondary | 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. | One participant with cerebral palsy consented, but did not participate in the protocol. Issues with the system precluded inclusion of 9 additional participants with cerebral palsy for the lateral support analysis. For kinetics, adequate force pate data was not acquired for one additional child with cerebral palsy during vertical support, as well as two children with cerebral palsy and three typically-developing children during lateral support. | Posted | Mean | Standard Deviation | Nm/kg | Initial trial without support (5-minutes) |
|
|
|
| Secondary | 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. | One participant with cerebral palsy consented, but did not participate in the protocol. Issues with the system precluded inclusion of 9 additional participants with cerebral palsy for the lateral support analysis. For kinetics, adequate force pate data was not acquired for two children with cerebral palsy during vertical support, as well as one typically-developing child during lateral support. | Posted | Mean | Standard Deviation | Nm/kg | Trial with maximum support (5-minutes) |
|
|
|
| Secondary | Passive Joint Range of Motion | Compare passive joint range of motion (degrees) measured by lower extremity physical exam | One participant with cerebral palsy consented, but did not participate in the protocol. | Posted | Mean | Standard Deviation | Degrees | One-time research visit (15 minutes) |
|
|
|
| Secondary | Selective Motor Control | Selective motor control (0 patterned movement - 2 complete isolated movement) | One participant with cerebral palsy consented, but did not participate in the protocol. | Posted | Mean | Standard Deviation | Units on a Scale | One-time research visit (15 minutes) |
|
|
|
| Secondary | Lower Extremity Strength | Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function) | One participant with cerebral palsy consented, but did not participate in the protocol. | Posted | Mean | Standard Deviation | Units on a Scale | One-time research visit (15 minutes) |
|
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Typically Developing Children (Controls) | Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Median Stance Pelvic Tilt (Lateral Support - Baseline) |
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| Peak Stance Hip Extension (Vertical Support - Baseline) |
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| Peak Stance Hip Extension (Lateral Support - Baseline) |
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| Peak Stance Knee Extension (Vertical Support - Baseline) |
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| Peak Stance Knee Extension (Lateral Support - Baseline) |
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| Peak Stance Ankle Plantarflexion (Vertical Support - Baseline) |
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| Peak Stance Ankle Plantarflexion (Lateral Support - Baseline) |
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| Median Stance Foot Progression (Vertical Support - Baseline) |
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| Median Stance Foot Progression (Lateral Support - Baseline) |
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| Median Stance Pelvic Tilt (Maximum Lateral Support) |
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| Peak Stance Hip Extension (Maximum Vertical Support) |
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| Peak Stance Hip Extension (Maximum Lateral Support) |
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| Peak Stance Knee Extension (Maximum Vertical Support) |
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| Peak Stance Knee Extension (Maximum Lateral Support) |
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| Peak Stance Ankle Plantarflexion (Maximum Vertical Support) |
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| Peak Stance Ankle Plantarflexion (Maximum Lateral Support) |
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| Median Stance Foot Progression (Maximum Vertical Support) |
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| Median Stance Foot Progression (Maximum Lateral Support) |
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| Peak Hip Extensor Moment (Lateral Support - Baseline) |
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| Peak Knee Extensor Moment (Vertical Support - Baseline) |
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| Peak Knee Extensor Moment (Lateral Support - Baseline) |
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| Peak Ankle Plantarflexor Moment (Vertical Support - Baseline) |
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| Peak Ankle Plantarflexor Moment (Lateral Support - Baseline) |
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| Peak Hip Extensor Moment (Maximum Lateral Support) |
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| Peak Knee Extensor Moment (Maximum Vertical Support) |
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| Peak Knee Extensor Moment (Maximum Lateral Support) |
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| Peak Ankle Plantarflexor Moment (Maximum Vertical Support) |
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| Peak Ankle Plantarflexor Moment (Maximum Lateral Support) |
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| Knee Extensor Lag |
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| Maximum Ankle Dorsiflexion |
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| Knee Extension |
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| Ankle Plantarflexion |
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| Knee Extensor Strength |
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| Plantarflexor Strength |
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