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: March 13, 2017

Last verified: March 2017

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 Intervention Model: Crossover Assignment Masking: 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:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Cristina Sadowsky, M.D., 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 ]
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 Outcome Measures:

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 ]


Enrollment:	18
Study Start Date:	September 2009
Estimated Primary Completion Date:	December 2018 (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

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)
Sexes Eligible for Study:	All
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:	March 13, 2017

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 June 23, 2017

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