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

NCT ID: NCT00833105

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-01-31

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).

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 13 subjects, more than 1 year post injury, were 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.

Conditions

Spinal Cord Injury; Tetraplegia; Paresis; Plegia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AMES treatment

Intervention Type: 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.

Interventions

AMES treatment

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shepherd Center, Atlanta GA

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Cordo

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J. Cordo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Deborah Backus, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Shepherd Center, Atlanta GA

Locations

Shepherd Center

Atlanta, Georgia, United States

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18645190 (View on PubMed)

Other Identifiers

4649

Identifier Type: -

Identifier Source: org_study_id

NCT00437515

Identifier Type: -

Identifier Source: nct_alias