Clinical trial NCT01498991: Spinal Cord Injury Leg Rehabilitation
Official title: Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Paraplegia
Quadriplegia
Tetraplegia
Keywords: Incomplete Spinal Cord Injury
Rehabilitation
AMES device
Lower Extremity
Gait
Paraplegia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Shepherd Center, Atlanta GA
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2011-12-26
Enrollment: 2
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 individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.

The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.

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 10 subjects, more than 1 year post injury, will be 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 the rehabilitation of the legs of participants with incomplete SCI.

Eligibility criteria: Inclusion Criteria:

* Paraplegia or tetraplegia due to SCI
* At least 1 year post incomplete Spinal Cord Injury
* Can tolerate sitting upright for at least one hour
* Capable of weight-bearing and taking a step with or without an assistive device
* On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5 level
* Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for each of these muscles in the qualifying leg

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), or other neurological injury or disease
* 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 or sitting upright
* 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
* Participation in another therapy or activity-based program
* Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and ankle plantarflexors outside the range of 3-9

Primary outcomes:
measure: Gait Velocity
timeFrame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Secondary outcomes:
measure: Vibration Threshold Test
timeFrame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
measure: Modified Ashworth Scale
timeFrame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
measure: Timed 10-Meter Walk Test
timeFrame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
measure: Gait Assessment Including Step Length and Cadence
timeFrame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
measure: Ankle Active Motion Test
timeFrame: Prior to each treatment session, on average 3 times a week
measure: Ankle Strength
timeFrame: Prior to each treatment session, on average 3 times a week
measure: ASIA Motor and Sensory Scores for L2-S1
timeFrame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center, Crawford Research 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, PhD
role: STUDY_DIRECTOR
affiliation: Oregon Health and Science University
name: Andrew Nemecek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shepherd Center, Atlanta GA
name: Deborah Backus, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: