Clinical trial NCT01005615: Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
Official title: Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2009-11-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Severity of Gleno-humeral Subluxation
timeFrame: Baseline
measure: Severity of Gleno-humeral Subluxation
timeFrame: 4 months
measure: Severity of Gleno-humeral Subluxation
timeFrame: 9 months
measure: Severity of Gleno-humeral Subluxation
timeFrame: 12 months
measure: Modified Ashworth Scale
timeFrame: Baseline, 4 months, 5 months, 9 months, 12 months
measure: Capabilities of the Upper Extremity (CUE) Test
timeFrame: Baseline, 4 months, 5 months, 9 months, 12 months
measure: Jebsen-Taylor Hand Function (JTHF) Test
timeFrame: Baseline, 4 months, 5 months, 9 months, 12 months
measure: Box and Blocks (BB) Test
timeFrame: Baseline, 4 months, 5 months, 9 months, 12 months
Secondary outcomes:
measure: Action Research Arm (ARA) Test
timeFrame: Baseline, 4 months, 5 months, 9 months, 12 months
measure: Range of Motion
timeFrame: Baseline, 4 months, 5 months, 9 months, 12 months
measure: Numerical Rating Scale (NRS).
timeFrame: Baseline, 4 months, 5 months, 9 months, 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Kennedy Krieger
name: Cristina L Sadowsky, MD
role: PRINCIPAL_INVESTIGATOR
References: