Clinical trial NCT00833105: Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury
Official title: Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Tetraplegia
Paresis
Plegia
Keywords: Incomplete Spinal Cord Injury
Rehabilitation
Upper Extremity
AMES device
Incomplete SCI
Quadriplegia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Shepherd Center, Atlanta GA
First posted: 2009-01-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device.

The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).

Detailed description: Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.

In this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in hand rehabilitation of incomplete SCI subjects.

Eligibility criteria: Inclusion Criteria:

* Traumatic SCI with tetraplegia.
* Male or female.
* 18-65 yrs old.
* At least 1 yr post-SCI.
* Tolerate sitting upright at for at least one hour.
* Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested.
* Motor grade \>1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested.
* Cognitively and behaviorally capable of complying with the regimen.

Exclusion Criteria:

* Fracture of the treated limb resulting in loss of range of motion
* Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study)
* DVT of the treated extremity
* Peripheral nerve injury of the treated extremity
* Osteo- or rheumatoid-arthritis limiting range of motion
* Contractures equal to or greater than 50% of the normal ROM
* Skin condition not tolerant of device
* Progressive neurodegenerative disorder
* Botox treatment of the treated extremity in the prior 5 month
* Chronic ITB therapy
* Uncontrolled seizure disorder
* Uncontrolled high blood pressure/angina
* Pain in affected limb or exercise intolerance

Primary outcomes:
measure: Grasp Release Test
timeFrame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Secondary outcomes:
measure: ASIA Motor Key Muscles
timeFrame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
measure: ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch
timeFrame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
measure: ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick
timeFrame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
measure: Van Lieshout Hand Function Test for Tetraplegia- Short Version
timeFrame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
measure: Modified Ashworth Scale
timeFrame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
measure: Capabilities of Upper Extremity Instrument
timeFrame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
measure: Strength Test - Thumb/Finger Extension
timeFrame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
measure: Strength Test - Thumb/Fingers Flexion
timeFrame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
measure: Strength Test - Wrist Extension
timeFrame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
measure: Strength Test - Wrist Flexion
timeFrame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
measure: Active Motion Test - Fingers/Thumb
timeFrame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
measure: Active Motion Test - Wrist
timeFrame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Paul J. Cordo, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shepherd Center, Atlanta GA
name: Deborah Backus, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.