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Spinal Cord Injury Leg Rehabilitation (AMES)

Primary Purpose

Spinal Cord Injury, Paraplegia, Quadriplegia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AMES Treatment

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Incomplete Spinal Cord Injury, Rehabilitation, AMES device, Lower Extremity, Gait, Paraplegia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shepherd Center, Crawford Research Center
Oregon Health and Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMES Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Gait Velocity

Measured by the GAITRite system

Secondary Outcome Measures

Vibration Threshold Test

Modified Ashworth Scale

Timed 10-Meter Walk Test

Gait Assessment Including Step Length and Cadence

Measured by the GAITRite system

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.

Ankle Strength

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

Full Information

NCT ID

NCT01498991

First Posted

December 8, 2011

Last Updated

May 2, 2019

Sponsor

Oregon Health and Science University

Collaborators

Shepherd Center, Atlanta GA, National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT01498991

Brief Title

Spinal Cord Injury Leg Rehabilitation

Acronym

AMES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Terminated

Study Start Date

November 2011 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

Collaborators

Shepherd Center, Atlanta GA, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury, Paraplegia, Quadriplegia, Tetraplegia

Keywords

Incomplete Spinal Cord Injury, Rehabilitation, AMES device, Lower Extremity, Gait, Paraplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMES Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

AMES Treatment

Intervention Description

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).

Primary Outcome Measure Information:

Title

Gait Velocity

Description

Measured by the GAITRite system

Time Frame

Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).

Secondary Outcome Measure Information:

Title

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).

Title

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).

Title

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).

Title

Gait Assessment Including Step Length and Cadence

Description

Measured by the GAITRite system

Time Frame

Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).

Title

Ankle Active Motion Test

Description

Time Frame

Prior to each treatment session, on average 3 times a week

Title

Ankle Strength

Description

The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction .

Time Frame

Prior to each treatment session, on average 3 times a week

Title

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul J Cordo, PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Andrew Nemecek, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Deborah Backus, PT, PhD

Organizational Affiliation

Shepherd Center, Atlanta GA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shepherd Center, Crawford Research Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Spinal Cord Injury Leg Rehabilitation

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