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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44HD082863-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The research is towards an advanced control and computer learning strategy that will intelligently drive a powered walker for people with walking disabilities. The aim of the control strategy is to provide powered assistance that optimally reduces the metabolic cost of walking. The goal of the proposed intelligent walker is to reduce the workload of walking, keeping this population walking longer, providing critical exercise, continued muscle development and improved quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SurePace Powered Walker User | Experimental | Before any formal experiments are conducted, participants will be given an opportunity to "train" with the new powered walker for a pre-defined period of time to eliminate the confounding effects of being unfamiliar with using the device. (See the description of UVA's facilities and Protection of Human Subjects document for additional discussion of safety measures/protocols and Institutional Review Board procedures.) Experiments will consist of one-hour sessions (with adequate rest periods between trials and time for evaluations) in which participants will be asked to walk at a self-selected (comfortable) walking speed through a pre-defined 8 m x 4 m oval course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SurePace Powered Walker User | Device | Participants will be asked to perform one baseline 5-minute trial with the lab's instrumented walker in passive mode (no powered locomotion) and two 5-minute trials with the walker in active mode (powered locomotion). |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Cost (Oxygen Consumption) | Oxygen consumption data will be collected with a Oxycon Mobile (VIASYS Healthcare Inc.) portable indirect calorimetry system. The outcome measure is the reduction in metabolic cost of using the powered walker compared to an unpowered walker. | Five minutes |
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Inclusion Criteria:
Typically developed subjects:
• No walking disabilities
Subjects with CP:
Exclusion Criteria:
Typically developed subjects:
• Observed intramuscular pathology
Subjects with CP:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Burkholder, Ph.D. | Barron Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Motion Analysis and Motor Performance Lab | Charlottesville | Virginia | 22903 | United States |
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48 enrolled participants met the inclusion criteria and completed the study.
Participants were recruited based on physician referral at the University of Virginia medical center. The first participant was enrolled in December 2020 and the last participant was enrolled in September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Subjects | Before any formal experiments are conducted, participants will be given an opportunity to "train" with the new powered walker for a pre-defined period of time to eliminate the confounding effects of being unfamiliar with using the device. (See the description of UVA's facilities and Protection of Human Subjects document for additional discussion of safety measures/protocols and Institutional Review Board procedures.) Experiments will consist of one-hour sessions (with adequate rest periods between trials and time for evaluations) in which participants will be asked to walk at a self-selected (comfortable) walking speed through a pre-defined 8 m x 4 m oval course. SurePace Powered Walker User: Participants will be asked to perform one baseline 5-minute trial with the lab's instrumented walker in passive mode (no powered locomotion) and two 5-minute trials with the walker in active mode (powered locomotion). |
| FG001 | Walking Disability Subjects | Subjects with walking disabilities, such as cerebral palsy (CP). Before any formal experiments are conducted, participants will be given an opportunity to "train" with the new powered walker for a pre-defined period of time to eliminate the confounding effects of being unfamiliar with using the device. (See the description of UVA's facilities and Protection of Human Subjects document for additional discussion of safety measures/protocols and Institutional Review Board procedures.) Experiments will consist of one-hour sessions (with adequate rest periods between trials and time for evaluations) in which participants will be asked to walk at a self-selected (comfortable) walking speed through a pre-defined 8 m x 4 m oval course. SurePace Powered Walker User: Participants will be asked to perform one baseline 5-minute trial with the lab's instrumented walker in passive mode (no powered locomotion) and two 5-minute trials with the walker in active mode (powered locomotion). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Subjects | Normally developed subjects without walking disabilities. |
| BG001 | Walking Disability Subjects | Subjects with walking disabilities, such as cerebral palsy. |
| 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 | Metabolic Cost (Oxygen Consumption) | Oxygen consumption data will be collected with a Oxycon Mobile (VIASYS Healthcare Inc.) portable indirect calorimetry system. The outcome measure is the reduction in metabolic cost of using the powered walker compared to an unpowered walker. | Posted | Mean | Standard Deviation | J/kg | Five minutes |
|
Through study completion, which was a single session, an average of 2 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 | Control Subjects: Unpowered Walker | Normally developed subjects without walking disabilities using unpowered walker. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Burkholder | Barron Associates, Inc. | 434-973-1215 | burkholder@bainet.com |
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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 | Sep 1, 2023 | Nov 7, 2024 | 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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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Control Subjects: Powered Walker |
Normally developed subjects using Powered Walker |
| OG003 | Walking Disability Subjects: Powered Walker | Subjects with walking disabilities, such as cerebral palsy, using the powered walker. |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Walking Disability Subjects: Unpowered Walker | Subjects with walking disabilities, such as cerebral palsy, using unpowered walker. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Control Subjects: Powered Walker | Normally developed subjects without walking disabilities using powered walker. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Walking Disability Subjects: Powered Walker | Subjects with walking disabilities, such as cerebral palsy, using powered walker. | 0 | 24 | 0 | 24 | 0 | 24 |
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