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

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Spinal Cord Injury

Treatments: Device: FES Stepping (RT600 from Restorative Therapies, INC.)

Study type: Interventional

Funder types: Other

Identifiers

NCT01479777

NA_00016421

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

FES Stepping

Experimental group

Description:

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.

Treatment:

Device: FES Stepping (RT600 from Restorative Therapies, INC.)