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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15HD099664-01 | 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 |
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The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).
Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the same participants will complete low frequency over-ground gait training (2x/week for 2 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait Training with Exoskeleton Assistance | Experimental | Gait training with ankle exoskeleton assistance. All participants received high frequency gait training followed by a washout period then low frequency gait training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| powered orthosis | Device | Novel powered leg brace to provide assistance during walking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Metabolic Energy Required to Walk | The change in the metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: change in % difference post vs pre gait training. | Measured at the pre (day 1) and post (day 4) gait training assessments |
| Change in Walking Speed | The change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments | Measured at the pre (day 1) and post (day 4) gait training assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stride Length | The change in the stride length will be measured by dividing the number of steps by distance traveled. Units: % change between post vs pre assessments. | Measured at the pre (day 1) and post (day 4) gait training assessments |
| Change in Cadence |
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Inclusion Criteria:
Exclusion Criteria:
• Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Arizona University | Flagstaff | Arizona | 86011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34758857 | Derived | Orekhov G, Fang Y, Cuddeback CF, Lerner ZF. Usability and performance validation of an ultra-lightweight and versatile untethered robotic ankle exoskeleton. J Neuroeng Rehabil. 2021 Nov 10;18(1):163. doi: 10.1186/s12984-021-00954-9. |
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All participants first completed higher frequency gait training followed by a washout period and then lower frequency gait training.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gait Training With Exoskeleton Assistance | All participants received high frequency gait training followed by a washout period then low frequency gait training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exoskeleton Assistance | Gait training with exoskeleton assistance at higher and lower frequencies. powered orthosis: Novel powered leg brace to provide assistance during walking. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Metabolic Energy Required to Walk | The change in the metabolic energy required to walk will be measured using a portable metabolic measurement system (Cosmed K5). Units: change in % difference post vs pre gait training. | Posted | Mean | Standard Deviation | % change pre vs post gait training | Measured at the pre (day 1) and post (day 4) gait training assessments |
|
Over the duration of the protocol, an average of two weeks.
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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 | Gait Training With Exoskeleton Assistance High Frequency | Gait training with ankle exoskeleton assistance at the higher frequency. |
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Small sample size due to participant recruitment challenges in our location and resulting from Covid 19.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zach Lerner, Associate Professor | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2023 | Dec 19, 2023 | 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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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Feasibility assessment of powered orthosis assistance and resistance during walking. All participants received high frequency gait training followed by a washout period then low frequency gait training.
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The change in the number of steps taken per minute will be measured using a counter. Units: % change between post vs pre assessments. |
| Measured at the pre (day 1) and post (day 4) gait training assessments |
| Change in Muscle Activity Variance Ratio | The change in the muscle activity variance ratio of the soleus during walking will be measured using electromyography electrodes. Units: % change between post vs pre assessments. | Measured at the pre (day 1) and post (day 4) gait training assessments |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Change in Walking Speed | The change in the walking speed will be measured over-ground using a stop watch. Units: % change between post vs pre assessments | Posted | Mean | Standard Deviation | % change post vs pre training | Measured at the pre (day 1) and post (day 4) gait training assessments |
|
|
|
|
| Secondary | Change in Stride Length | The change in the stride length will be measured by dividing the number of steps by distance traveled. Units: % change between post vs pre assessments. | Posted | Mean | Standard Deviation | % change post vs pre training | Measured at the pre (day 1) and post (day 4) gait training assessments |
|
|
|
|
| Secondary | Change in Cadence | The change in the number of steps taken per minute will be measured using a counter. Units: % change between post vs pre assessments. | Posted | Mean | Standard Deviation | % change post vs pre training | Measured at the pre (day 1) and post (day 4) gait training assessments |
|
|
|
|
| Secondary | Change in Muscle Activity Variance Ratio | The change in the muscle activity variance ratio of the soleus during walking will be measured using electromyography electrodes. Units: % change between post vs pre assessments. | Posted | Mean | Standard Deviation | % change post vs pre training | Measured at the pre (day 1) and post (day 4) gait training assessments |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Gait Training With Exoskeleton Assistance Low Frequency | Gait training with ankle exoskeleton assistance at the lower frequency. | 0 | 6 | 0 | 6 | 0 | 6 |
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