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

NCT00833105 | Completed Results DMC

• 1 other identifier: 4649
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Spinal Cord Injury; Tetraplegia; Paresis; Plegia

Keywords

Incomplete Spinal Cord Injury; Rehabilitation; Upper Extremity; AMES device; Incomplete SCI; Quadriplegia

Outcome Measures

Primary Outcomes (1)

• Grasp Release Test

  The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.

  Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training

Secondary Outcomes (12)

• ASIA Motor Key Muscles

  Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training

• ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch

  Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training

• ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick

  Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training

• Van Lieshout Hand Function Test for Tetraplegia- Short Version

  Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training

• Modified Ashworth Scale

  Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training

Study Arms (1)

AMES treatment

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.

Device: AMES treatment

Interventions

AMES treatment DEVICE

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.

AMES treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic SCI with tetraplegia.
• Male or female.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Shepherd Center, Atlanta GA: collaborator

Study Sites (2)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Oregon Health and Science University

Portland, Oregon, 97006, United States

Location

Related Publications (1)

• Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.

  PMID: 18645190 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Paresis; Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. Not a controlled study. 2. Zone of partial preservation not fully characterized. 3. Changes in somatosensation were not quantified. 4. Five participants were trained for both ULs, so training of first UL may have affected second UL.

Results Point of Contact

• Title: Dr. Paul Cordo
• Organization: Oregon Health & Science University

cordop@ohsu.edu

503 418 2520

Study Officials

• Paul J. Cordo, Ph.D

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Deborah Backus, PhD, PT

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 1, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-04

Locations

US (2)