Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Functional electrical stimulation, Rehabilitation
Brief summary
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.
Detailed description
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).
Interventions
DEVICEFES Stepping (RT600 from Restorative Therapies, INC.)
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.
Sponsors
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male, Female, age 18-65, all ethnic groups * Spinal Cord Injury, traumatic and non-traumatic * C1-T12 neurological level * ASIA class A-D * Chronic injury \> 6 months from the injury * Visible motor response to FES stimulation (visible muscle contraction evoked with electrical stimulation) * Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues * Subjects are able to comply with procedures and follow-up
Exclusion criteria
* Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability * History of inability to tolerate electrical stimulation * Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability * Uncontrolled hypertension (resting systolic BP \> 160mmHg or diastolic BP \>100mmHg consistently) * Presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices other than baclofen pumps * Unstable long bone fractures of the lower extremities * Presence of stage III or greater skin ulcerations that would preclude application of stimulating pads * Malignancy * History of epileptic seizures * Women who are pregnant * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Fractures less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) | Baseline, 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate | Baseline, 8 weeks | Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters. |
| Change in Systolic Blood Pressure | Baseline, 8 weeks | Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters. |
| Change in Diastolic Plood Pressure | Baseline, 8 weeks | Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters. |
| Change in Rate of Perceived Exertion | Baseline, 8 weeks | 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. |
| Change in Vital Capacity | Baseline, 8 weeks | Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters. |
| Change in Peak Cough Flow | Baseline, 8 weeks | Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FES Stepping FES Stepping, twice a week, for 8 weeks. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | FES Stepping |
|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FES Stepping | Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) | Upper Extremity Motor Score | 1.0 scores on AIS Scale |
| FES Stepping | Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) | Lower Extremity Motor Score | 2.7 scores on AIS Scale |
| FES Stepping | Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) | Light Touch | 2.4 scores on AIS Scale |
| FES Stepping | Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) | Pin prick | -1.2 scores on AIS Scale |
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Stepping | Change in Diastolic Plood Pressure | 1.8 mmHg |
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Stepping | Change in Heart Rate | -3.3 beats per minute |
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Stepping | Change in Peak Cough Flow | -6 liters/minute |
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Stepping | Change in Rate of Perceived Exertion | -0.64 scores on RPE scale |
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Stepping | Change in Systolic Blood Pressure | 1.1 mmHg |
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.
Time frame: Baseline, 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Stepping | Change in Vital Capacity | -0.29 litres |