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

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Spinal Cord Injury

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01005615

w81xwh-08-2-0192

W81XWH-09-2-0186

NA_00014481

Details and patient eligibility

About

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.

Full 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).

Enrollment: 19 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups

No FES Cycling

Sham Comparator group

Treatment:

Device: Non-FES Upper Extremity Exercise

FES Cycling

Active Comparator group

Treatment:

Device: RT300-SLSA, from Restorative Therapies, Inc.