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Completed

NCT Number: NCT01479777

Functional Electrical Stimulation (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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FES Stepping (RT600 from Restorative Therapies, INC.)

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.

Other names: RT600 from Restorative Therapies, INC.

Primary outcomes

  1. Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)

    Time frame: Baseline, 8 weeks

    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 outcomes

  1. Change in Heart Rate

    Time frame: Baseline, 8 weeks

    Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.

  2. Change in Systolic Blood Pressure

    Time frame: Baseline, 8 weeks

    Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.

  3. Change in Diastolic Plood Pressure

    Time frame: Baseline, 8 weeks

    Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.

  4. Change in Rate of Perceived Exertion

    Time frame: Baseline, 8 weeks

    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.

  5. Change in Vital Capacity

    Time frame: Baseline, 8 weeks

    Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.

  6. Change in Peak Cough Flow

    Time frame: Baseline, 8 weeks

    Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

FES Driven Stepping in Individuals With Spinal Cord Injury

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 24, 2011
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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