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NCT04303078

Quantifying Energetic Demands of Walking for People With Cerebral Palsy

Completed NA Results posted Last updated 27 January 2026
What this trial tests

NA trial testing Varying levels of harness support during walking in Cerebral Palsy in 34 participants. Completed in 17 June 2025.

Timeline
15 August 2023
Primary endpoint
17 June 2025
17 June 2025

Quick facts

Lead sponsorUniversity of Washington
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment34
Start date15 August 2023
Primary completion17 June 2025
Estimated completion17 June 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

Adults 8 to 17, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Net Nondimensional Oxygen Cost Primary · 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.

Percent Change (Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)-34.13± 21.45
Typically Developing Children (Controls)-15.86± 17.76
Percent Change (Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)1.07± 7.07
Typically Developing Children (Controls)-0.60± 10.19
Three-dimensional Gait Kinematics (Baseline) Secondary · Initial trial without support (5-minutes)

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.

Median Stance Pelvic Tilt (Vertical Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)21.6± 8.0
Typically Developing Children (Controls)13.6± 6.6
Median Stance Pelvic Tilt (Lateral Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)23.4± 9.2
Typically Developing Children (Controls)16.2± 7.6
Peak Stance Hip Extension (Vertical Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)24.3± 11.5
Typically Developing Children (Controls)13.2± 7.4
Peak Stance Hip Extension (Lateral Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)27.1± 12.0
Typically Developing Children (Controls)16.5± 9.5
Peak Stance Knee Extension (Vertical Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)14.1± 12.9
Typically Developing Children (Controls)0.1± 3.8
Peak Stance Knee Extension (Lateral Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)13.3± 10.2
Typically Developing Children (Controls)0.5± 6.8
Peak Stance Ankle Plantarflexion (Vertical Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)-1.2± 8.7
Typically Developing Children (Controls)-6.1± 2.4
Peak Stance Ankle Plantarflexion (Lateral Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)-0.8± 6.9
Typically Developing Children (Controls)-5.3± 3.4
Three-dimensional Gait Kinematics (Support) Secondary · Trial with maximum support (5-minutes)

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.

Median Stance Pelvic Tilt (Maximum Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)22.1± 9.5
Typically Developing Children (Controls)18.0± 6.7
Median Stance Pelvic Tilt (Maximum Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)23.0± 8.3
Typically Developing Children (Controls)16.4± 8.3
Peak Stance Hip Extension (Maximum Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)21.5± 11.9
Typically Developing Children (Controls)15.4± 8.3
Peak Stance Hip Extension (Maximum Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)28.0± 10.1
Typically Developing Children (Controls)16.1± 9.9
Peak Stance Knee Extension (Maximum Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)13.0± 12.9
Typically Developing Children (Controls)1.8± 7.8
Peak Stance Knee Extension (Maximum Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)15.0± 8.8
Typically Developing Children (Controls)0.4± 5.3
Peak Stance Ankle Plantarflexion (Maximum Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)-2.0± 9.4
Typically Developing Children (Controls)-4.9± 5.2
Peak Stance Ankle Plantarflexion (Maximum Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)-0.1± 6.9
Typically Developing Children (Controls)-5.1± 2.1
Three-dimensional Gait Kinetics (Baseline) Secondary · Initial trial without support (5-minutes)

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.

Peak Hip Extensor Moment (Vertical Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.462± 0.156
Typically Developing Children (Controls)0.604± 0.153
Peak Hip Extensor Moment (Lateral Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.447± 0.122
Typically Developing Children (Controls)0.613± 0.255
Peak Knee Extensor Moment (Vertical Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.160± 0.132
Typically Developing Children (Controls)0.321± 0.095
Peak Knee Extensor Moment (Lateral Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.119± 0.097
Typically Developing Children (Controls)0.306± 0.158
Peak Ankle Plantarflexor Moment (Vertical Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.026± 0.032
Typically Developing Children (Controls)0.068± 0.035
Peak Ankle Plantarflexor Moment (Lateral Support - Baseline)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.033± 0.028
Typically Developing Children (Controls)0.074± 0.038
Three-dimensional Gait Kinetics (Support) Secondary · Trial with maximum support (5-minutes)

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.

Peak Hip Extensor Moment (Maximum Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.269± 0.046
Typically Developing Children (Controls)0.312± 0.104
Peak Hip Extensor Moment (Maximum Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.465± 0.119
Typically Developing Children (Controls)0.559± 0.152
Peak Knee Extensor Moment (Maximum Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.103± 0.052
Typically Developing Children (Controls)0.177± 0.053
Peak Knee Extensor Moment (Maximum Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.122± 0.133
Typically Developing Children (Controls)0.302± 0.092
Peak Ankle Plantarflexor Moment (Maximum Vertical Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.012± 0.016
Typically Developing Children (Controls)0.035± 0.027
Peak Ankle Plantarflexor Moment (Maximum Lateral Support)
GroupValue95% CI
Children With Cerebral Palsy (Cases)0.026± 0.031
Typically Developing Children (Controls)0.056± 0.031
Passive Joint Range of Motion Secondary · One-time research visit (15 minutes)

Compare passive joint range of motion (degrees) measured by lower extremity physical exam

Popliteal Angle
GroupValue95% CI
Children With Cerebral Palsy (Cases)51.478± 11.747
Typically Developing Children (Controls)34.000± 9.416
Maximum Knee Extension
GroupValue95% CI
Children With Cerebral Palsy (Cases)-0.435± 6.940
Typically Developing Children (Controls)-4.700± 4.523
Knee Extensor Lag
GroupValue95% CI
Children With Cerebral Palsy (Cases)3.174± 6.336
Typically Developing Children (Controls)0.000± 0.000
Maximum Ankle Dorsiflexion
GroupValue95% CI
Children With Cerebral Palsy (Cases)4.043± 6.725
Typically Developing Children (Controls)13.200± 4.341
Selective Motor Control Secondary · One-time research visit (15 minutes)

Selective motor control (0 patterned movement - 2 complete isolated movement)

Hip Flexion
GroupValue95% CI
Children With Cerebral Palsy (Cases)1.348± 0.487
Typically Developing Children (Controls)2.000± 0.000
Hip Extension
GroupValue95% CI
Children With Cerebral Palsy (Cases)1.826± 0.388
Typically Developing Children (Controls)2.000± 0.000
Knee Extension
GroupValue95% CI
Children With Cerebral Palsy (Cases)1.870± 0.458
Typically Developing Children (Controls)2.000± 0.000
Ankle Plantarflexion
GroupValue95% CI
Children With Cerebral Palsy (Cases)1.565± 0.662
Typically Developing Children (Controls)2.000± 0.000
Lower Extremity Strength Secondary · One-time research visit (15 minutes)

Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)

Back Extensor Strength
GroupValue95% CI
Children With Cerebral Palsy (Cases)4.391± 1.076
Typically Developing Children (Controls)5.000± 0.000
Hip Extensor Strength
GroupValue95% CI
Children With Cerebral Palsy (Cases)3.652± 1.071
Typically Developing Children (Controls)5.000± 0.000
Knee Extensor Strength
GroupValue95% CI
Children With Cerebral Palsy (Cases)4.913± 0.417
Typically Developing Children (Controls)5.000± 0.000
Plantarflexor Strength
GroupValue95% CI
Children With Cerebral Palsy (Cases)3.130± 1.325
Typically Developing Children (Controls)5.000± 0.000

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04303078.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing