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The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that paralyzes.
Muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion of the legs. The FES stepping in this study will be done through a device called the RT600 FES Stepper (RT600).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES Stepping | Experimental | For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES Stepping (RT600 from Restorative Therapies, INC.) | Device | You will be transferred to the RT600 device and secured in a support harness. We will place your legs onto the RT600 device and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs, buttock, stomach, and back. The pads will be connected to a stimulator box through a wire. We will then start the stepping motor and stimulate your muscles with electric current. This will cause your legs to step. You will do this for 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) | Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome. AIS Classificatrion: A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5. B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal. | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate | Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters. | Baseline, 8 weeks |
| Change in Systolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina L Sadowsky, MD | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FES Stepping | For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FES Stepping | FES Stepping, twice a week, for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Motor and Sensory Scores of the ASIA Impairment Scale (AIS) | Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome. AIS Classificatrion: A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5. B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal. | Posted | Mean | Full Range | scores on AIS Scale | Baseline, 8 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 | FES Stepping | FES Stepping, twice a week, for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle Swelling (X-ray negative for bone fracture or dislocation) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Reported swelling and bruise on medial aspect of ankle X-ray negative for bone fracture, dislocation Resume FES stepping by taking precautions by giving ankles more support: ace bandage wrapping; wear ankle supportive running shoes (high tops) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cristina Sadowsky | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | 443-923-9210 | sadowsky@kennedykrieger.org |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.
| Baseline, 8 weeks |
| Change in Diastolic Plood Pressure | Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters. | Baseline, 8 weeks |
| Change in Rate of Perceived Exertion | Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters. The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion. | Baseline, 8 weeks |
| Change in Vital Capacity | Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters. | Baseline, 8 weeks |
| Change in Peak Cough Flow | Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters. | Baseline, 8 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| FES Stepping |
FES Stepping, twice a week, for 8 weeks. |
|
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| Secondary | Change in Heart Rate | Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters. | Posted | Mean | Full Range | beats per minute | Baseline, 8 weeks |
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| Secondary | Change in Systolic Blood Pressure | Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters. | Posted | Mean | Full Range | mmHg | Baseline, 8 weeks |
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| Secondary | Change in Diastolic Plood Pressure | Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters. | Posted | Mean | Full Range | mmHg | Baseline, 8 weeks |
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| Secondary | Change in Rate of Perceived Exertion | Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters. The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion. | Posted | Mean | Full Range | scores on RPE scale | Baseline, 8 weeks |
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| Secondary | Change in Vital Capacity | Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters. | Posted | Mean | Full Range | litres | Baseline, 8 weeks |
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| Secondary | Change in Peak Cough Flow | Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters. | Posted | Mean | Full Range | liters/minute | Baseline, 8 weeks |
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| 0 |
| 12 |
| 6 |
| 12 |
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| Lightheadedness | Cardiac disorders | Non-systematic Assessment | FES was stopped. participant rested, and symptoms resolved. Did not affect continued participation in study |
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| Increased tone in lower extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Increased tone did not interfere with FES stepping |
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| D014947 | Wounds and Injuries |