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This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
Objectives:
Hypothesis:
Procedures:
Participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. Percentage range of motion (ROM), partial body weight support (PWBS), and gait velocity are the principal parameters under variation during training.
Additionally, screening, baseline and post-training testing sessions will be conducted
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPWalker Robotic-Assisted Gait Training | Experimental | Each subject will participate in 16-24 gait training sessions in the CPWalker over the course of 8 weeks with each session lasting up to 2 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPWalker Robotic Exoskeleton | Device | The CPWalker rehabilitation platform is a robotic device composed by an exoskeleton linked to a walker that provides support and balance to a child during overground training. The device is able to implement user's partial body weight support (PBWS) and allows the adaptation of exercises to the patient's capabilities by means of individual controllers for each joint, which increases the modularity of the system. Each joint of the CPWalker can operate in a range of modes with varied levels of robotic assistance or resistance |
| Measure | Description | Time Frame |
|---|---|---|
| 10-Meter Walk Test | This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 10-meter distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second. | Change from baseline gait speed at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Test | This test measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Jayaraman, PT, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
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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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| Change from baseline distance ambulated at 8 weeks |
| GAITRite Data Collection | The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter "flying start" to compensate for initial acceleration. | Change from baseline gait quality at 8 weeks |
| Pediatric Balance Scale | This test is a 14-item objective measure designed to assess static balance in pediatric populations. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. | Change from baseline balance score at 8 weeks |
| Selective Control Assessment of Lower Extremity (SCALE) | This clinical tool quantifies selective voluntary motor control of the lower extremities in patients with cerebral palsy. | Change from baseline selective voluntary motor control at 8 weeks |
| Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking) | This test measures the change in gross motor function with intervention in children with cerebral palsy | Change from baseline gross motor function at 8 weeks |
| Child and Adolescent Scale of Participation | This questionnaire measures the extent to which children participate in home, school, and community activities as reported by family caregivers. | Change in children's baseline participation in activities at 8 weeks |
| Gillette Functional Assessment Questionnaire (FAQ) | This is a proxy-report measure that includes a ten-level classification of ambulatory function and 22 functional locomotor activities | Change in baseline report of ambulatory function at 8 weeks |