Spinal Cord Injury Leg Rehabilitation

NCT ID: NCT01498991

Last Updated: 2019-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-11-30

Brief Summary

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

The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.

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 10 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 the rehabilitation of the legs of participants with incomplete SCI.

Conditions

Spinal Cord Injury; Paraplegia; Quadriplegia; Tetraplegia

Study Design

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

Study Groups

AMES Treatment

The subject will receive 30 treatment sessions, conducted 3-4 times per week on the AMES device. Each session will consist of testing followed by 40 minutes of treatment time (20 minutes per each leg) using the AMES device.

Group Type: EXPERIMENTAL

AMES Treatment

Intervention Type: DEVICE

The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).

Interventions

AMES Treatment

The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Paraplegia or tetraplegia due to SCI
• At least 1 year post incomplete Spinal Cord Injury
• Can tolerate sitting upright for at least one hour
• Capable of weight-bearing and taking a step with or without an assistive device
• On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5 level
• Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for each of these muscles in the qualifying leg

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), or other neurological injury or disease
• 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 or sitting upright
• 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
• Participation in another therapy or activity-based program
• Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and ankle plantarflexors outside the range of 3-9

• 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

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

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, PhD

Role: STUDY_DIRECTOR

Oregon Health and Science University

Andrew Nemecek, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Deborah Backus, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shepherd Center, Atlanta GA

Locations

Shepherd Center, Crawford Research Center

Atlanta, Georgia, United States

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

R01NS061304-22

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00007762

Identifier Type: -

Identifier Source: org_study_id