Clinical trial NCT01479777: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Functional electrical stimulation
Rehabilitation
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in Heart Rate
timeFrame: Baseline, 8 weeks
measure: Change in Systolic Blood Pressure
timeFrame: Baseline, 8 weeks
measure: Change in Diastolic Plood Pressure
timeFrame: Baseline, 8 weeks
measure: Change in Rate of Perceived Exertion
timeFrame: Baseline, 8 weeks
measure: Change in Vital Capacity
timeFrame: Baseline, 8 weeks
measure: Change in Peak Cough Flow
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Cristina L Sadowsky, MD
role: PRINCIPAL_INVESTIGATOR
References: