Spinal Cord Injury Leg Rehabilitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI)

Conditions
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Spinal Cord Injury, Paraplegia, Quadriplegia, Tetraplegia

Intervention / Treatment
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* Device: AMES Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMES Treatment<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Velocity | Measured by the GAITRite system | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vibration Threshold Test |  | 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 |  | 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 |  | 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 | Measured by the GAITRite system | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). | 
| Ankle Active Motion Test | 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. | Prior to each treatment session, on average 3 times a week | 
| Ankle Strength | The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction . | Prior to each treatment session, on average 3 times a week | 
| ASIA Motor and Sensory Scores for L2-S1 |  | Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incomplete Spinal Cord Injury, Rehabilitation, AMES device, Lower Extremity, Gait, Paraplegia