Overview

This trial is active, not recruiting.

Conditions spinal cord injury, tetraplegia, paresis, plegia
Treatment ames treatment
Phase phase 1/phase 2
Sponsor Oregon Health and Science University
Collaborator Shepherd Center, Atlanta GA
Start date January 2009
End date December 2014
Trial size 20 participants
Trial identifier NCT00833105, 4649

Summary

The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device.

The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.
ames treatment AMES treatment
The AMES device rotates the fingers-thumb and the wrist over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the hand. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device.

Primary Outcomes

Measure
Grasp Release Test
time frame: After enrollment and prior to the start of treatment
Grasp Release Test
time frame: After the completion of all treatments
Grasp Release Test
time frame: Three months following the end of the treatments

Secondary Outcomes

Measure
ASIA grade for motor score and sensory score of the upper extremity being treated
time frame: After enrollment and prior to the start of the treatments
Van Lieshout Test - Short Version
time frame: After enrollment and prior to the start of treatment
Modified Ashworth Scale
time frame: After enrollment and prior to the start of treatments
Capabilities of Upper Extremities
time frame: After enrollment and prior to the start of treatment
Self-Care Activities Supplement
time frame: After enrollment and prior to the start of treatments
Joint Position Test
time frame: Prior to each treatment session
Strength Test
time frame: Prior to each treatment session
Joint Stiffness Test
time frame: Prior to each treatment session
2 Point Discrimination
time frame: After enrollment and prior to the start of treatment
ASIA grade for motor score and sensory score of the upper extremity being treated
time frame: After completion of all treatments
Van Lieshout Test - Short Version
time frame: After completion of all treatments
Modified Ashworth Scale
time frame: After completion of all treatments
Capabilities of Upper Extremities
time frame: After completion of all treatments
Self-Care Activities Supplement
time frame: After completion of all treatments
2 Point Discrimination
time frame: After completion of all treatments
ASIA grade for motor score and sensory score of the upper extremity being treated
time frame: 3 months following the end of the treatments
Van Lieshout Test - Short Version
time frame: 3 months following the end of the treatments
Modified Ashworth Scale
time frame: 3 months following the end of the treatments
Capabilities of Upper Extremity
time frame: 3 months following the end of the treatments
Self-Care Activities Supplement
time frame: 3 months following the end of the treatments
2 Point Discrimination
time frame: 3 months following the end of the treatments

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Traumatic SCI with tetraplegia. - Male or female. - 18-65 yrs old. - At least 1 yr post-SCI. - Tolerate sitting upright at for at least one hour. - Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested. - Motor grade >1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested. - Cognitively and behaviorally capable of complying with the regimen. 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) - 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 - 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

Additional Information

Official title Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)
Principal investigator Paul J. Cordo, Ph.D
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 20 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 hand rehabilitation of incomplete SCI subjects.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.