Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Shepherd Center, Atlanta GA
Information provided by (Responsible Party):
Paul J. Cordo, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00833105
First received: January 29, 2009
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Spinal Cord Injury
Tetraplegia
Paresis
Plegia
Device: AMES treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Grasp Release Test [ Time Frame: After enrollment and prior to the start of treatment ] [ Designated as safety issue: No ]
  • Grasp Release Test [ Time Frame: After the completion of all treatments ] [ Designated as safety issue: No ]
  • Grasp Release Test [ Time Frame: Three months following the end of the treatments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Van Lieshout Test - Short Version [ Time Frame: After enrollment and prior to the start of treatment ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale [ Time Frame: After enrollment and prior to the start of treatments ] [ Designated as safety issue: No ]
  • Capabilities of Upper Extremities [ Time Frame: After enrollment and prior to the start of treatment ] [ Designated as safety issue: No ]
  • Self-Care Activities Supplement [ Time Frame: After enrollment and prior to the start of treatments ] [ Designated as safety issue: No ]
  • Joint Position Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
  • Strength Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
  • Joint Stiffness Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
  • 2 Point Discrimination [ Time Frame: After enrollment and prior to the start of treatment ] [ Designated as safety issue: No ]
  • ASIA grade for motor score and sensory score of the upper extremity being treated [ Time Frame: After completion of all treatments ] [ Designated as safety issue: No ]
  • Van Lieshout Test - Short Version [ Time Frame: After completion of all treatments ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale [ Time Frame: After completion of all treatments ] [ Designated as safety issue: No ]
  • Capabilities of Upper Extremities [ Time Frame: After completion of all treatments ] [ Designated as safety issue: No ]
  • Self-Care Activities Supplement [ Time Frame: After completion of all treatments ] [ Designated as safety issue: No ]
  • 2 Point Discrimination [ Time Frame: After completion of all treatments ] [ Designated as safety issue: No ]
  • ASIA grade for motor score and sensory score of the upper extremity being treated [ Time Frame: 3 months following the end of the treatments ] [ Designated as safety issue: No ]
  • Van Lieshout Test - Short Version [ Time Frame: 3 months following the end of the treatments ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale [ Time Frame: 3 months following the end of the treatments ] [ Designated as safety issue: No ]
  • Capabilities of Upper Extremity [ Time Frame: 3 months following the end of the treatments ] [ Designated as safety issue: No ]
  • Self-Care Activities Supplement [ Time Frame: 3 months following the end of the treatments ] [ Designated as safety issue: No ]
  • 2 Point Discrimination [ Time Frame: 3 months following the end of the treatments ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMES treatment
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.
Device: 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.
Other Name: AMES treatment

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833105

Locations
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97006
Sponsors and Collaborators
Oregon Health and Science University
Shepherd Center, Atlanta GA
Investigators
Principal Investigator: Paul J. Cordo, Ph.D Oregon Health and Science University
Principal Investigator: Deborah Backus, PhD, PT Shepherd Center, Atlanta GA
  More Information

Publications:
Responsible Party: Paul J. Cordo, Study Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00833105     History of Changes
Other Study ID Numbers: 4649
Study First Received: January 29, 2009
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Incomplete Spinal Cord Injury
Rehabilitation
Upper Extremity
AMES device
Incomplete SCI
Quadriplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014