Spinal Cord Injury Leg Rehabilitation

Phase 1

Terminated

Conditions: Paraplegia
Tetraplegia
Spinal Cord Injury
Quadriplegia

Interventions: Device: AMES Treatment

Registration Number: NCT01498991

Lead Sponsor: Oregon Health and Science University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMES Treatment	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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).
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).
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).
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 .
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).

Trial Locations

Locations (2): Shepherd Center, Crawford Research Center
🇺🇸
Atlanta, Georgia, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States