Spinal Cord Injury Leg Rehabilitation (AMES)

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injury; Tetraplegia; Quadriplegia; Paraplegia
• Intervention / Treatment: Device: AMES Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center, Crawford Research Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Shepherd Center, Atlanta GA
• 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, Atlanta GA

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait; Lower Extremity; Incomplete Spinal Cord Injury; AMES device; Paraplegia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Wounds and Injuries; Spinal Cord Injuries; Quadriplegia; Paraplegia
• Other Study ID Numbers: IRB00007762; R01NS061304-22 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No