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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FES Stepping (RT600 from Restorative Therapies, INC.)
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Functional electrical stimulation, Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES Stepping

Arm 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.

Outcomes

Primary Outcome Measures

Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
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
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
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
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
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
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
Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.

Full Information

First Posted
November 15, 2011
Last Updated
September 9, 2014
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01479777
Brief Title
Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury
Official Title
FES Driven Stepping in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Functional electrical stimulation, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES Stepping
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
FES Stepping (RT600 from Restorative Therapies, INC.)
Other Intervention Name(s)
RT600 from Restorative Therapies, INC.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
Description
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.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in Heart Rate
Description
Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.
Time Frame
Baseline, 8 weeks
Title
Change in Systolic Blood Pressure
Description
Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.
Time Frame
Baseline, 8 weeks
Title
Change in Diastolic Plood Pressure
Description
Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.
Time Frame
Baseline, 8 weeks
Title
Change in Rate of Perceived Exertion
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change in Vital Capacity
Description
Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.
Time Frame
Baseline, 8 weeks
Title
Change in Peak Cough Flow
Description
Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina L Sadowsky, MD
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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

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