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: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Device: FES Stepping (RT600 from Restorative Therapies, INC.)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FES Driven Stepping in Individuals With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]

    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:
  • Change in Heart Rate [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.

  • Change in Systolic Blood Pressure [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.


Enrollment: 12
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479777

Locations
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
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.
  More Information

No publications provided

Responsible Party: Cristina Sadowsky, M.D., Assistant Professor Physical Medicine and Rehabilitation, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01479777     History of Changes
Other Study ID Numbers: NA_00016421
Study First Received: November 15, 2011
Results First Received: August 1, 2013
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Spinal Cord Injury
Functional electrical stimulation
Rehabilitation

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014