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

Phase 1

Terminated

Conditions: Spinal Cord Injury

Interventions: Device: Non-FES Upper Extremity Exercise
Device: RT300-SLSA, from Restorative Therapies, Inc.

Registration Number: NCT01005615

Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Brief 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.

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).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No FES Cycling	Non-FES Upper Extremity Exercise	-
FES Cycling	RT300-SLSA, from Restorative Therapies, Inc.	-

Primary Outcome Measures

Name	Time	Method
Severity of Gleno-humeral Subluxation	12 months	This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally
Capabilities of the Upper Extremity (CUE) Test	Baseline, 4 months, 5 months, 9 months, 12 months	This is a routine exam performed for people with spinal cord injury.The CUE test is a 32-item interview. It is designed to self-assess upper extremity performance on a 7-point scale (nominal scale, \[45\]).Subjects are questioned while sitting in their wheelchairs. A brief description of the test will be read to the subjects and then questions asked, one at a time. Subjects will give verbal responses on a 7-point likert scale. total score possible is 0- 225, higher the score better outcome
Box and Blocks (BB) Test	Baseline, 4 months, 5 months, 9 months, 12 months	This is a routine exam performed for people with spinal cord injury. The BB assesses gross hand function. Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The BB requires subjects to reach for, lift, and move one inch cubes across a divider inside a wooden box. The amount of time (seconds) subject is able to move around is measured. Higher scores mean better outcome by timed test.
Modified Ashworth Scale	Baseline, 4 months, 5 months, 9 months, 12 months	This is a routine exam performed for people with spinal cord injury.The Modified Ashworth Scale assesses muscle resistance to passive movement. The evaluator moves the joint through the available range of motion and assigns a score from 0-4, where 0 is no tone and 4 is fixed limb (ordinal scale, \[44\]).Subjects are tested in a seated position preferably in their wheelchairs. The subjects' upper extremity is stabilized by the examiner above and below the joint to be tested. Then the joint is quickly moved through the previously determined subjects' maximum range of motion
Jebsen-Taylor Hand Function (JTHF) Test	Baseline, 4 months, 5 months, 9 months, 12 months	This is a routine exam performed for people with spinal cord injury.The JTHF test is a 7-item test designed to objectively assess various hand functions and speed of performance (ordinal scale, \[46\]). Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The JTHF requires subjects to reach for, lift, and in some cases manipulate small objects. smallest time in seconds mean a better outcome

Secondary Outcome Measures

Name	Time	Method
Range of Motion	Baseline, 4 months, 5 months, 9 months, 12 months	This is a routine exam performed for people with spinal cord injury. Subjects are tested in a seated position, preferably in their wheelchairs. The desired joint is isolated and moved through the maximum available range of motion. Once the end range is reached, joint excursion is measured with a goniometer. This measure is to see if you have any active range of motion. 1 is yes to active range of motion and 0 is no range of motion. Having active range of motion is a better outcome
Action Research Arm (ARA) Test	Baseline, 4 months, 5 months, 9 months, 12 months	This is a routine exam performed for people with spinal cord injury.The ARA test observationally assesses upper extremity function .Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The ARA requires subjects to handle objects differing in size, weight and shape. Score range is from 0-57, higher the number means better outcome overall
Numerical Rating Scale (NRS).	Baseline, 4 months, 5 months, 9 months, 12 months	This is a routine exam performed for people with spinal cord injury. Subjects report how much pain they are having by choosing a number from 0-10, 0 being no pain and 10 being the worst pain