Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Sponsor:
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: September 6, 2016
Last verified: September 2016
History of Changes
  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:

U.S. FDA Resources

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 ]
Enrollment: 18
Study Start Date: September 2009
Estimated Primary Completion Date: October 2016 (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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005615

Locations
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
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

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: September 6, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 28, 2016