Phase 2
Completed N=12
Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury
Source: ClinicalTrials.gov NCT01479777 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) — 1.0; 2.7; 2.4; -1.2 scores on AIS Scale
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.
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 | — |
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
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. Informational only — not medical advice.