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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01479777
First received: November 15, 2011
Last updated: April 17, 2013
Last verified: April 2013
History of Changes

November 15, 2011
April 17, 2013
April 2011
April 2012   (final data collection date for primary outcome measure)
ASIA Exam [ Time Frame: Baseline ] [ Designated as safety issue: No ]
A neurological exam, called the ASIA, to determine the extent of motor and sensory impairment that you are experiencing as a result of your spinal cord injury.
Same as current
Complete list of historical versions of study NCT01479777 on ClinicalTrials.gov Archive Site
ASIA Exam [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
A neurological exam, called the ASIA, to determine the extent of motor and sensory impairment that you are experiencing as a result of your spinal cord injury.
Same as current
Not Provided
Not Provided
 
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.

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). The use of RT600 FES Stepper in this research study is investigational. The word "investigational" means that RT600 FES Stepper is not approved for marketing by the Food and Drug Administration (FDA).
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injury
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 Name: RT600 from Restorative Therapies, INC.
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.
Intervention: Device: FES Stepping (RT600 from Restorative Therapies, INC.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01479777
NA_00016421
Yes
Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Not Provided
Principal Investigator: Cristina L Sadowsky, MD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP