CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
AMES treatmentdevice
Likely dose
AMES device: 20 minutes of fingers-thumb or wrist movement with vibratory proprioceptive feedbackAI-extracted
Key inclusion· 7
  • ✓Traumatic spinal cord injury with tetraplegia
  • ✓Age 18-65 years
  • ✓At least 1 year post-SCI
  • ✓Able to sit upright for at least one hour
Key exclusion· 13
  • ✕Fracture of treated limb with loss of range of motion
  • ✕Concomitant traumatic brain injury or stroke (mild head injury without structural abnormalities allowed)
  • ✕Deep vein thrombosis of treated extremity
  • ✕Peripheral nerve injury of treated extremity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00833105
NCT00833105N/ACompleted
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Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)

Oregon Health and Science University·interventional·Posted Jan 30, 2009·Updated May 1, 2019

In Brief

A clinical study evaluating AMES treatment for Spinal Cord Injury and 3 related conditions. Completed, enrolled 13 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury, Tetraplegia, Paresis, Plegia
CountriesUnited States
CollaboratorsShepherd Center, Atlanta GA

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 30, 2009
Enrollment StartJan 1, 2009
Primary CompletionNov 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.4 years ago

Interventions

AMES treatmentdevice

The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. 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.