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

NCT ID: NCT01479777

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-04-30

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).

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FES Stepping (RT600 from Restorative Therapies, INC.)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

RT600 from Restorative Therapies, INC.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Cristina Sadowsky, M.D.

Assistant Professor Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina L Sadowsky, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00016421

Identifier Type: -

Identifier Source: org_study_id