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



Status:Active, not recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 55
Updated:4/3/2019
Start Date:September 2009

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Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury

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.

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).

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
We found this trial at
1
site
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Phone: 443-923-9235
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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from
Baltimore, MD
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