Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatments non-fes upper extremity exercise, rt300-slsa, from restorative therapies, inc.
Phase phase 1/phase 2
Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator U.S. Army Medical Research and Materiel Command
Start date September 2009
End date October 2016
Trial size 18 participants
Trial identifier NCT01005615, NA_00014481, W81XWH-09-2-0186, w81xwh-08-2-0192

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
non-fes upper extremity exercise
While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months.
(Active Comparator)
rt300-slsa, from restorative therapies, inc.
They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen

Primary Outcomes

Measure
X-ray
time frame: Initial, 4 months, 5 months, 9 months, 12 months
Modified Ashworth scale
time frame: Initial, 4 months, 5 months, 9 months, 12 months
Capabilities of the Upper Extremity (CUE) test
time frame: Initial, 4 months, 5 months, 9 months, 12 months
Jebsen-Taylor Hand Function (JTHF) test
time frame: Initial, 4 months, 5 months, 9 months, 12 months
Box and Blocks (BB) test
time frame: Initial, 4 months, 5 months, 9 months, 12 months

Secondary Outcomes

Measure
Action Research Arm (ARA) test
time frame: Initial, 4 months, 5 months, 9 months, 12 months
Range of motion
time frame: Initial, 4 months, 5 months, 9 months, 12 months
Numerical Rating Scale (NRS).
time frame: Initial, 4 months, 5 months, 9 months, 12 months
American Spinal Injury Association (ASIA) exam
time frame: Initial, 4 months, 5 months, 9 months, 12 months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
Principal investigator Cristina L Sadowsky, MD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc..