AMES: Spinal Cord Injury Leg Rehabilitation

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01498991
• Collaborator: Shepherd Center, Atlanta GA (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 2
• Locations: 2
• Arm: 1
• Duration (Months): 60
• Patient Per Site: 1
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury; Paraplegia; Quadriplegia; Tetraplegia	Device: AMES Treatment	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI)
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Gait Velocity [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

Secondary Outcome Measures

1. 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).]

2. 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).]

3. 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).]

4. Gait Assessment Including Step Length and Cadence [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

5. Ankle Active Motion Test [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.

6. Ankle Strength [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 .

7. 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).]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Shepherd Center, Crawford Research Center	Atlanta	Georgia	United States	30309
2	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

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

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul J. Cordo, Study Principal Investigator, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01498991
• Other Study ID Numbers: IRB00007762; R01NS061304-22
• First Posted: Dec 26, 2011
• Last Update Posted: May 24, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Paul J. Cordo, Study Principal Investigator, Oregon Health and Science University: Incomplete Spinal Cord Injury; Rehabilitation; AMES device; Lower Extremity; Gait; Paraplegia
• Additional relevant MeSH terms: Spinal Cord Injuries; Paraplegia; Quadriplegia; Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Overall Participants	2
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30 (1.5)
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 50%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

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).

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

2. Secondary Outcome

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).

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

3. Secondary Outcome

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).

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

4. Secondary Outcome

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).

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

5. Secondary Outcome

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).

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

6. Secondary Outcome

Title	Ankle Active Motion Test
Description	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.
Time Frame	Prior to each treatment session, on average 3 times a week

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

8. Secondary Outcome

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).

Outcome Measure Data

Analysis Population Description

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
Measure Participants	0

Adverse Events

Arm/Group Title	AMES Treatment
Arm/Group 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. 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).
All Cause Mortality
	AMES Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AMES Treatment
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	AMES Treatment
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.