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

Spinal Cord Injury Clinical Trial

Official title:

FES Driven Stepping in Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479777
• Other study ID #: NA_00016421
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 15, 2011
• Last updated: September 9, 2014
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2014
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 8 weeks	No
Secondary	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.	Baseline, 8 weeks	Yes
Secondary	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.	Baseline, 8 weeks	Yes
Secondary	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.	Baseline, 8 weeks	Yes
Secondary	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.	Baseline, 8 weeks	Yes
Secondary	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.	Baseline, 8 weeks	Yes
Secondary	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.	Baseline, 8 weeks	Yes