View Clinical Trial (Medical Research Study)

Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury - NCT01005615-21205(Clinical Trial 398806)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Baltimore
State:  
MD
Zip Code: 21205
Conditions: Spinal Cord Injury
Purpose: To determine whether functional electrical stimulation (FES) promotes neurological and physical recovery in patients with spinal cord injury (SCI). The researchers will investigate the extent of functional recovery in patients with spinal cord injury who receive functional electrical stimulation in the upper extremities compared with patients who do not receive FES.
Study summary: A randomized, controlled, single-blinded, in-subject controlled (A-B type) trial will be performed in patients with SCI receiving an upper extremities non-FES assisted exercise protocol compared with patients receiving upper extremities ergometry in combination with FES. Neurological and functional outcome measures will be obtained at baseline (time 0), after 1st 4 months of intervention (4 months), after 1 month washout (5 months),after 2nd 4 months intervention (9 months), and 3 month after completing the last intervention (12 months).
Criteria: Inclusion Criteria: - Male, Female, age 18-55, all ethnic groups - Spinal Cord Injury, traumatic and non-traumatic - C1-C6 neurological level - ASIA class A-B - Chronic injury > 12 months and < 20 years from the injury - No upper-extremity electrical stimulation in the previous 4 weeks - Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues - Baseline physical activity is kept stable - Pain and antispasticity medications dose are kept stable - Subjects are legally able to make their own health care decisions Exclusion Criteria: - Associated lower motor neuron/peripheral nerve injury in the C1-C6 levels - Presence of pacemaker - Presence of cancer - History of seizures - Women who are pregnant
Study is available at: Kennedy Krieger Institute
Baltimore, MD 21205
United States

Primary Contact:
Shannon M Inches
Email: inches@kennedykrieger.org
Phone: 443-923-9235

Secondary Contact:
Shannon M Inches
Email: Inches@kennedykrieger.org
Phone: 443-923-9235
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.