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

FES Driven Stepping in Individuals With Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: FES Stepping (RT600 from Restorative Therapies, INC.)

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Kennedy Krieger Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: FES 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.; Other Names: RT600 from Restorative Therapies, INC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Investigators: Principal Investigator: Cristina L Sadowsky, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): September 15, 2014
• Last Update Submitted That Met QC Criteria: September 9, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Spinal Cord Injury; Functional electrical stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: NA_00016421