Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury

Phase 1

Completed

• Conditions: Spinal Cord Injury
• Interventions: Device: FES Stepping (RT600 from Restorative Therapies, INC.)

• Registration Number: NCT01479777
• Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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).

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-24
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-08-01
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Results First Posted: 2014-09-15
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FES Stepping	FES Stepping (RT600 from Restorative Therapies, INC.)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States