Trial Outcomes & Findings for Quantifying Energetic Demands of Walking for People With Cerebral Palsy (NCT NCT04303078)
NCT ID: NCT04303078
Last Updated: 2026-01-27
Results Overview
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.
COMPLETED
NA
34 participants
Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)
2026-01-27
Participant Flow
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.
Participant milestones
| Measure |
Children With Cerebral Palsy (Cases)
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
10
|
|
Overall Study
COMPLETED
|
23
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Children With Cerebral Palsy (Cases)
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Quantifying Energetic Demands of Walking for People With Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Children With Cerebral Palsy (Cases)
n=24 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.8 years
STANDARD_DEVIATION 3.0 • n=41 Participants
|
12.8 years
STANDARD_DEVIATION 2.9 • n=1581 Participants
|
12.8 years
STANDARD_DEVIATION 2.9 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
32 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
32 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline walking trial with harness on (5-minutes) and support walking trials with vertical or lateral support in harness system (5-minutes)Population: 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.
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.
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Net Nondimensional Oxygen Cost
Percent Change (Vertical Support)
|
-34.13 Percent change relative to baseline
Standard Deviation 21.45
|
-15.86 Percent change relative to baseline
Standard Deviation 17.76
|
|
Net Nondimensional Oxygen Cost
Percent Change (Lateral Support)
|
1.07 Percent change relative to baseline
Standard Deviation 7.07
|
-0.60 Percent change relative to baseline
Standard Deviation 10.19
|
SECONDARY outcome
Timeframe: Initial trial without support (5-minutes)Population: 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.
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.
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Three-dimensional Gait Kinematics (Baseline)
Median Stance Pelvic Tilt (Vertical Support - Baseline)
|
21.6 Degrees
Standard Deviation 8.0
|
13.6 Degrees
Standard Deviation 6.6
|
|
Three-dimensional Gait Kinematics (Baseline)
Median Stance Pelvic Tilt (Lateral Support - Baseline)
|
23.4 Degrees
Standard Deviation 9.2
|
16.2 Degrees
Standard Deviation 7.6
|
|
Three-dimensional Gait Kinematics (Baseline)
Peak Stance Hip Extension (Vertical Support - Baseline)
|
24.3 Degrees
Standard Deviation 11.5
|
13.2 Degrees
Standard Deviation 7.4
|
|
Three-dimensional Gait Kinematics (Baseline)
Peak Stance Hip Extension (Lateral Support - Baseline)
|
27.1 Degrees
Standard Deviation 12.0
|
16.5 Degrees
Standard Deviation 9.5
|
|
Three-dimensional Gait Kinematics (Baseline)
Peak Stance Knee Extension (Vertical Support - Baseline)
|
14.1 Degrees
Standard Deviation 12.9
|
0.1 Degrees
Standard Deviation 3.8
|
|
Three-dimensional Gait Kinematics (Baseline)
Peak Stance Knee Extension (Lateral Support - Baseline)
|
13.3 Degrees
Standard Deviation 10.2
|
0.5 Degrees
Standard Deviation 6.8
|
|
Three-dimensional Gait Kinematics (Baseline)
Peak Stance Ankle Plantarflexion (Vertical Support - Baseline)
|
-1.2 Degrees
Standard Deviation 8.7
|
-6.1 Degrees
Standard Deviation 2.4
|
|
Three-dimensional Gait Kinematics (Baseline)
Peak Stance Ankle Plantarflexion (Lateral Support - Baseline)
|
-0.8 Degrees
Standard Deviation 6.9
|
-5.3 Degrees
Standard Deviation 3.4
|
|
Three-dimensional Gait Kinematics (Baseline)
Median Stance Foot Progression (Vertical Support - Baseline)
|
-5.7 Degrees
Standard Deviation 10.1
|
-5.6 Degrees
Standard Deviation 10.2
|
|
Three-dimensional Gait Kinematics (Baseline)
Median Stance Foot Progression (Lateral Support - Baseline)
|
-6.2 Degrees
Standard Deviation 9.0
|
-5.4 Degrees
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Trial with maximum support (5-minutes)Population: 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.
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.
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Three-dimensional Gait Kinematics (Support)
Peak Stance Ankle Plantarflexion (Maximum Vertical Support)
|
-2.0 Degrees
Standard Deviation 9.4
|
-4.9 Degrees
Standard Deviation 5.2
|
|
Three-dimensional Gait Kinematics (Support)
Median Stance Pelvic Tilt (Maximum Vertical Support)
|
22.1 Degrees
Standard Deviation 9.5
|
18.0 Degrees
Standard Deviation 6.7
|
|
Three-dimensional Gait Kinematics (Support)
Median Stance Pelvic Tilt (Maximum Lateral Support)
|
23.0 Degrees
Standard Deviation 8.3
|
16.4 Degrees
Standard Deviation 8.3
|
|
Three-dimensional Gait Kinematics (Support)
Peak Stance Hip Extension (Maximum Vertical Support)
|
21.5 Degrees
Standard Deviation 11.9
|
15.4 Degrees
Standard Deviation 8.3
|
|
Three-dimensional Gait Kinematics (Support)
Peak Stance Hip Extension (Maximum Lateral Support)
|
28.0 Degrees
Standard Deviation 10.1
|
16.1 Degrees
Standard Deviation 9.9
|
|
Three-dimensional Gait Kinematics (Support)
Peak Stance Knee Extension (Maximum Vertical Support)
|
13.0 Degrees
Standard Deviation 12.9
|
1.8 Degrees
Standard Deviation 7.8
|
|
Three-dimensional Gait Kinematics (Support)
Peak Stance Knee Extension (Maximum Lateral Support)
|
15.0 Degrees
Standard Deviation 8.8
|
0.4 Degrees
Standard Deviation 5.3
|
|
Three-dimensional Gait Kinematics (Support)
Peak Stance Ankle Plantarflexion (Maximum Lateral Support)
|
-0.1 Degrees
Standard Deviation 6.9
|
-5.1 Degrees
Standard Deviation 2.1
|
|
Three-dimensional Gait Kinematics (Support)
Median Stance Foot Progression (Maximum Vertical Support)
|
-4.1 Degrees
Standard Deviation 10.9
|
-3.9 Degrees
Standard Deviation 8.9
|
|
Three-dimensional Gait Kinematics (Support)
Median Stance Foot Progression (Maximum Lateral Support)
|
-6.5 Degrees
Standard Deviation 9.7
|
-8.5 Degrees
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Initial trial without support (5-minutes)Population: 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.
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.
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Three-dimensional Gait Kinetics (Baseline)
Peak Hip Extensor Moment (Vertical Support - Baseline)
|
0.462 Nm/kg
Standard Deviation 0.156
|
0.604 Nm/kg
Standard Deviation 0.153
|
|
Three-dimensional Gait Kinetics (Baseline)
Peak Hip Extensor Moment (Lateral Support - Baseline)
|
0.447 Nm/kg
Standard Deviation 0.122
|
0.613 Nm/kg
Standard Deviation 0.255
|
|
Three-dimensional Gait Kinetics (Baseline)
Peak Knee Extensor Moment (Vertical Support - Baseline)
|
0.160 Nm/kg
Standard Deviation 0.132
|
0.321 Nm/kg
Standard Deviation 0.095
|
|
Three-dimensional Gait Kinetics (Baseline)
Peak Knee Extensor Moment (Lateral Support - Baseline)
|
0.119 Nm/kg
Standard Deviation 0.097
|
0.306 Nm/kg
Standard Deviation 0.158
|
|
Three-dimensional Gait Kinetics (Baseline)
Peak Ankle Plantarflexor Moment (Vertical Support - Baseline)
|
0.026 Nm/kg
Standard Deviation 0.032
|
0.068 Nm/kg
Standard Deviation 0.035
|
|
Three-dimensional Gait Kinetics (Baseline)
Peak Ankle Plantarflexor Moment (Lateral Support - Baseline)
|
0.033 Nm/kg
Standard Deviation 0.028
|
0.074 Nm/kg
Standard Deviation 0.038
|
SECONDARY outcome
Timeframe: Trial with maximum support (5-minutes)Population: 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.
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.
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Three-dimensional Gait Kinetics (Support)
Peak Hip Extensor Moment (Maximum Vertical Support)
|
0.269 Nm/kg
Standard Deviation 0.046
|
0.312 Nm/kg
Standard Deviation 0.104
|
|
Three-dimensional Gait Kinetics (Support)
Peak Hip Extensor Moment (Maximum Lateral Support)
|
0.465 Nm/kg
Standard Deviation 0.119
|
0.559 Nm/kg
Standard Deviation 0.152
|
|
Three-dimensional Gait Kinetics (Support)
Peak Knee Extensor Moment (Maximum Vertical Support)
|
0.103 Nm/kg
Standard Deviation 0.052
|
0.177 Nm/kg
Standard Deviation 0.053
|
|
Three-dimensional Gait Kinetics (Support)
Peak Knee Extensor Moment (Maximum Lateral Support)
|
0.122 Nm/kg
Standard Deviation 0.133
|
0.302 Nm/kg
Standard Deviation 0.092
|
|
Three-dimensional Gait Kinetics (Support)
Peak Ankle Plantarflexor Moment (Maximum Vertical Support)
|
0.012 Nm/kg
Standard Deviation 0.016
|
0.035 Nm/kg
Standard Deviation 0.027
|
|
Three-dimensional Gait Kinetics (Support)
Peak Ankle Plantarflexor Moment (Maximum Lateral Support)
|
0.026 Nm/kg
Standard Deviation 0.031
|
0.056 Nm/kg
Standard Deviation 0.031
|
SECONDARY outcome
Timeframe: One-time research visit (15 minutes)Population: One participant with cerebral palsy consented, but did not participate in the protocol.
Compare passive joint range of motion (degrees) measured by lower extremity physical exam
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Passive Joint Range of Motion
Popliteal Angle
|
51.478 Degrees
Standard Deviation 11.747
|
34.000 Degrees
Standard Deviation 9.416
|
|
Passive Joint Range of Motion
Maximum Knee Extension
|
-0.435 Degrees
Standard Deviation 6.940
|
-4.700 Degrees
Standard Deviation 4.523
|
|
Passive Joint Range of Motion
Knee Extensor Lag
|
3.174 Degrees
Standard Deviation 6.336
|
0.000 Degrees
Standard Deviation 0.000
|
|
Passive Joint Range of Motion
Maximum Ankle Dorsiflexion
|
4.043 Degrees
Standard Deviation 6.725
|
13.200 Degrees
Standard Deviation 4.341
|
SECONDARY outcome
Timeframe: One-time research visit (15 minutes)Population: One participant with cerebral palsy consented, but did not participate in the protocol.
Selective motor control (0 patterned movement - 2 complete isolated movement)
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Selective Motor Control
Hip Flexion
|
1.348 Units on a Scale
Standard Deviation 0.487
|
2.000 Units on a Scale
Standard Deviation 0.000
|
|
Selective Motor Control
Hip Extension
|
1.826 Units on a Scale
Standard Deviation 0.388
|
2.000 Units on a Scale
Standard Deviation 0.000
|
|
Selective Motor Control
Knee Extension
|
1.870 Units on a Scale
Standard Deviation 0.458
|
2.000 Units on a Scale
Standard Deviation 0.000
|
|
Selective Motor Control
Ankle Plantarflexion
|
1.565 Units on a Scale
Standard Deviation 0.662
|
2.000 Units on a Scale
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: One-time research visit (15 minutes)Population: One participant with cerebral palsy consented, but did not participate in the protocol.
Lower extremity strength measures by the manual muscle test (0 no muscle contraction - 5 typical muscle function)
Outcome measures
| Measure |
Children With Cerebral Palsy (Cases)
n=23 Participants
Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.
|
Typically Developing Children (Controls)
n=10 Participants
Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.
|
|---|---|---|
|
Lower Extremity Strength
Knee Extensor Strength
|
4.913 Units on a Scale
Standard Deviation 0.417
|
5.000 Units on a Scale
Standard Deviation 0.000
|
|
Lower Extremity Strength
Plantarflexor Strength
|
3.130 Units on a Scale
Standard Deviation 1.325
|
5.000 Units on a Scale
Standard Deviation 0.000
|
|
Lower Extremity Strength
Hip Extensor Strength
|
3.652 Units on a Scale
Standard Deviation 1.071
|
5.000 Units on a Scale
Standard Deviation 0.000
|
|
Lower Extremity Strength
Back Extensor Strength
|
4.391 Units on a Scale
Standard Deviation 1.076
|
5.000 Units on a Scale
Standard Deviation 0.000
|
Adverse Events
Children With Cerebral Palsy (Cases)
Typically Developing Children (Controls)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place