Spinal Cord Injury Leg Rehabilitation (AMES)
This study is currently recruiting participants.
Verified December 2012 by Oregon Health and Science University
Sponsor:
Oregon Health and Science University
Collaborators:
Shepherd Center
Information provided by (Responsible Party):
Paul J. Cordo, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01498991
First received: December 8, 2011
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury Paraplegia Quadriplegia Tetraplegia |
Device: AMES Treatment |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI) |
Resource links provided by NLM:
Further study details as provided by Oregon Health and Science University:
Primary Outcome Measures:
- 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). ] [ Designated as safety issue: No ]Measured by the GAITRite system
Secondary Outcome Measures:
- 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). ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: No ]Measured by the GAITRite system
- Ankle Active Motion Test [ Time Frame: Prior to each treatment session, on average 3 times a week ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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). ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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).
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498991
Contacts
| Contact: Paul J Cordo, PhD | 503-418-2520 | cordop@ohsu.edu |
Locations
| United States, Georgia | |
| Shepherd Center, Crawford Research Center | Not yet recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Heather Guerrero 404-350-7522 Heather_Guerrero@Shepherd.org | |
| Principal Investigator: Deborah Backus, PT, PhD | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Linda D Cordo, BSN, MSN 503-223-3442 cordol@ohsu.edu | |
| Principal Investigator: Andrew Nemecek, MD | |
| Sub-Investigator: Ahmed Raslan, MD | |
| Sub-Investigator: Paul J Cordo, PhD | |
Sponsors and Collaborators
Oregon Health and Science University
Shepherd Center
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Paul J. Cordo, Study Principal Investigator, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01498991 History of Changes |
| Other Study ID Numbers: | IRB00007762, R01NS061304-22 |
| Study First Received: | December 8, 2011 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Incomplete Spinal Cord Injury Rehabilitation AMES device |
Lower Extremity Gait Paraplegia |
Additional relevant MeSH terms:
|
Paraplegia Quadriplegia Spinal Cord Injuries Paralysis Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013