Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
This study is currently recruiting participants.
Verified April 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01005615
First received: October 29, 2009
Last updated: April 15, 2013
Last verified: April 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Device: Non-FES Upper Extremity Exercise Device: RT300-SLSA, from Restorative Therapies, Inc. |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury |
Resource links provided by NLM:
Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Primary Outcome Measures:
- X-ray [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- Modified Ashworth scale [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- Capabilities of the Upper Extremity (CUE) test [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- Jebsen-Taylor Hand Function (JTHF) test [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- Box and Blocks (BB) test [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Action Research Arm (ARA) test [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- Range of motion [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- Numerical Rating Scale (NRS). [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
- American Spinal Injury Association (ASIA) exam [ Time Frame: Initial, 4 months, 5 months, 9 months, 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: No FES Cycling |
Device: 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: FES Cycling |
Device: 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
|
Detailed 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).
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005615
Contacts
| Contact: Shannon M Inches | 443-923-9235 | Inches@kennedykrieger.org |
Locations
| United States, Maryland | |
| Kennedy Krieger Institute | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Shannon M Inches 443-923-9235 inches@kennedykrieger.org | |
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
U.S. Army Medical Research and Materiel Command
Investigators
| Principal Investigator: | Cristina L Sadowsky, MD | Kennedy Krieger |
More Information
Additional Information:
No publications provided
| Responsible Party: | Cristina Sadowsky, M.D., Director, Paralysis Restoration Clinic, International Center for Spinal Cord Injury, Kennedy Krieger Institute; Assistant Professor, Johns Hopkins University School of Medicine, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| ClinicalTrials.gov Identifier: | NCT01005615 History of Changes |
| Other Study ID Numbers: | NA_00014481, w81xwh-08-2-0192, W81XWH-09-2-0186 |
| Study First Received: | October 29, 2009 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013