Phase 2 N=12 Treatment

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

Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT01479777 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) — 1.0; 2.7; 2.4; -1.2 scores on AIS Scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: FES Stepping (RT600 from Restorative Therapies, INC.) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)	1.0; 2.7; 2.4; -1.2	—
SECONDARY Change in Heart Rate	-3.3	—
SECONDARY Change in Systolic Blood Pressure	1.1	—
SECONDARY Change in Diastolic Plood Pressure	1.8	—
SECONDARY Change in Rate of Perceived Exertion	-0.64	—
SECONDARY Change in Vital Capacity	-0.29	—
SECONDARY Change in Peak Cough Flow	-6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01479777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.