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This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.
Our first aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor push-off power and range of motion compared to standard (physician prescribed) AFOs during walking in CP.
Our second aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor muscle activity while maintaining improved posture compared to standard AFOs during walking in CP.
Our third aim is to validate the need and usability of real-time stiffness adjustment during play and school activities; obtain feedback from the children, their parents, and orthotists to design the MVP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Participants will walk with the new AFO, their own AFOs, and no AFOs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Differential and adjustable stiffness AFO (DAS-AFO) | Device | Walking with a differential and adjustable stiffness AFO (DAS-AFO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Activity | Change in integrated soleus electromyography (mV/mV) muscle activity during stance phase of walking. | day 1 |
| Change in Metabolic Cost of Transport | Change in metabolic cost of transport during walking. To calculate the metabolic cost of transport, the standing baseline metabolic rate for each participant and each trial was subtracted from their walking metabolic rate to estimate the net metabolic rate of walking. Next, we normalized the net metabolic rate of walking by each participant's body mass (m) and walking speed to calculate the metabolic cost of transport (J/kg*m), averaged over the last two minutes of each condition. | day 1 |
| Change in Ankle Power | Change in peak ankle power during stance phase measured in w/kg. Ankle kinematics and kinetics were calculated in OpenSim using the collected three-dimensional motion capture and the ground reaction forces. The joint kinematics and ground reaction forces were filtered using a low pass fourth order recursive Butterworth filter with a cut-off frequency of 6 Hz before being used to calculate joint kinetics. The ground reaction forces were collected using two force places associated with the instrumented treadmill (Bertec Corp, Columbus, USA) collected at 1200 Hz. The resultant joint kinetics were then further filtered using the same filtering parameters. Ankle joint power was calculated as the product of the joint moment and joint angular velocity. | 1 day during walking |
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Inclusion Criteria:
Exclusion Criteria:
-Excessive knee flexion during walking caused by CP
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Arizona University | Flagstaff | Arizona | 86011 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Muscle Activity | Change in integrated soleus electromyography (mV/mV) muscle activity during stance phase of walking. | Posted | Mean | Standard Deviation | percent change based on mV/mV measures | day 1 |
|
|
2 days during the study protocol
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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 | Study Group | Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PI | Northern Arizona University | 928-523-1787 | zachary.lerner@nau.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2024 | Feb 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2024 | Feb 5, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 18, 2024 | Feb 5, 2025 | ICF_002.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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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Primary | Change in Metabolic Cost of Transport | Change in metabolic cost of transport during walking. To calculate the metabolic cost of transport, the standing baseline metabolic rate for each participant and each trial was subtracted from their walking metabolic rate to estimate the net metabolic rate of walking. Next, we normalized the net metabolic rate of walking by each participant's body mass (m) and walking speed to calculate the metabolic cost of transport (J/kg*m), averaged over the last two minutes of each condition. | Posted | Mean | Standard Deviation | J/kg*m | day 1 |
|
|
|
| Primary | Change in Ankle Power | Change in peak ankle power during stance phase measured in w/kg. Ankle kinematics and kinetics were calculated in OpenSim using the collected three-dimensional motion capture and the ground reaction forces. The joint kinematics and ground reaction forces were filtered using a low pass fourth order recursive Butterworth filter with a cut-off frequency of 6 Hz before being used to calculate joint kinetics. The ground reaction forces were collected using two force places associated with the instrumented treadmill (Bertec Corp, Columbus, USA) collected at 1200 Hz. The resultant joint kinetics were then further filtered using the same filtering parameters. Ankle joint power was calculated as the product of the joint moment and joint angular velocity. | Posted | Mean | Standard Deviation | w/kg | 1 day during walking |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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