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Spinal Cord Injury Leg Rehabilitation (AMES)

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ClinicalTrials.gov Identifier: NCT01498991
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
Shepherd Center, Atlanta GA
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Paul J. Cordo, Oregon Health and Science University

December 8, 2011
December 26, 2011
November 28, 2016
November 2011
November 2016   (Final data collection date for primary outcome measure)
Gait Velocity [ Time Frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). ]
Measured by the GAITRite system
Same as current
Complete list of historical versions of study NCT01498991 on ClinicalTrials.gov Archive Site
  • Vibration Threshold Test [ Time Frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). ]
  • Modified Ashworth Scale [ Time Frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). ]
  • Timed 10-Meter Walk Test [ Time Frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). ]
  • Gait Assessment including Step Length and Cadence [ Time Frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). ]
    Measured by the GAITRite system
  • Ankle Active Motion Test [ Time Frame: Prior to each treatment session, on average 3 times a week ]
    The participants will perform an active range-of-motion (ROM) task each time they are treated with the AMES device, in which they move the affected joint to several target joint angles, guided by visual feedback on a display screen on the AMES device.
  • Ankle Strength [ Time Frame: Prior to each treatment session, on average 3 times a week ]
    The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction .
  • ASIA Motor and Sensory Scores for L2-S1 [ Time Frame: Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). ]
Same as current
Not Provided
Not Provided
 
Spinal Cord Injury Leg Rehabilitation
Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI)

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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Spinal Cord Injury
  • Paraplegia
  • Quadriplegia
  • Tetraplegia
Device: AMES Treatment
The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).
Experimental: AMES Treatment
The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.
Intervention: Device: AMES Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
10
November 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01498991
IRB00007762
R01NS061304-22 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Paul J. Cordo, Oregon Health and Science University
Oregon Health and Science University
  • Shepherd Center, Atlanta GA
  • National Institute of Neurological Disorders and Stroke (NINDS)
Study Director: Paul J Cordo, PhD Oregon Health and Science University
Principal Investigator: Andrew Nemecek, MD Oregon Health and Science University
Principal Investigator: Deborah Backus, PT, PhD Shepherd Center, Atlanta GA
Oregon Health and Science University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP