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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
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The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury.
The primary aims of this study are to:
Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function.
Aim 2: Investigate participant perceptions of spinal stimulation.
The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Training Only | Active Comparator | Physical and gait training that targets rehabilitation of walking function. |
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| Intensive Training Combined with Spinal Stimulation | Active Comparator | Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait Training | Other | Training that targets rehabilitation of walking function |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline - Six Minute Walk Test | Measure of walking ability. The distance is reported in meters. | Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months. |
| Change from baseline - Ten Meter Walk Test | The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second. | Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system | Measurement of leg function and walking ability. Joint angle is reported in angle degrees, and velocity is reported in meters per second. Kinematic analysis will able to used to measure gait coordination and spatiotemporal outcomes, such as step length and step time. | Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siddhi R Shrivastav, BPTh, MS | Contact | 973-444-1940 | siddhis@uw.edu | |
| Chet T Moritz, PhD | Contact | 206-221-2842 | ctmoritz@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katherine M Steele, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98115 | United States |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Transcutaneous Spinal Stimulation | Device | Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training |
|
| Change from baseline - Electromyography recording of lower extremity muscles | Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts. | Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. |
| Change from baseline - Gait Outcomes Assessment List | The patient-reported outcome measure for ambulatory children with cerebral palsy. The Gait Outcomes Assessment List comprises 48 items distributed across 7 subscales and spans all domains of the International Classification of Functioning, Disability, and Health. The score range is between 0 and 100. The higher scores mean a better outcome. | Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. |
| Change from baseline - Timed Up and Go | Measurement of mobility and fall risk. The time to complete the test is recorded in seconds. | Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. |
| Change from baseline - Modified Ashworth and Tardieu Scales | Measurement of spasticity in muscles. The score range is between 0 and 5. The lower scores mean a better outcome. | Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months. |
| Change from baseline - Patient-Reported Outcomes Measurement Information System Pediatric Profile | Includes six domains. These are depression, Anxiety, Physical Function-Mobility, Pain Interference, Fatigue, and Peer Relationships. Each domain contains 8 items, along with a single item on Pain Intensity scored between 0 to 10. The score range for each domain is between 1 and 5. The lower scores mean a better outcome. | Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months. |