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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01498991
Other study ID # IRB00007762
Secondary ID R01NS061304-22
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date November 2011
Est. completion date November 2016

Study information

Verified date May 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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).

Locations

Country Name City State
United States Shepherd Center, Crawford Research Center Atlanta Georgia
United States Oregon Health and Science University Portland Oregon

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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
Secondary 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
Secondary 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).
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