Spinal Cord Injury Leg Rehabilitation

NCT01498991 | Terminated Phase 1 Results DMC

• 2 other identifiers: IRB00007762R01NS061304-22
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury; Paraplegia; Quadriplegia; Tetraplegia

Keywords

Incomplete Spinal Cord Injury; Rehabilitation; AMES device; Lower Extremity; Gait; Paraplegia

Outcome Measures

Primary Outcomes (1)

• Gait Velocity

  Measured by the GAITRite system

  Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).

Secondary Outcomes (7)

• Vibration Threshold Test

  Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).

• Modified Ashworth Scale

  Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).

• Timed 10-Meter Walk Test

  Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).

• Gait Assessment Including Step Length and Cadence

  Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).

• Ankle Active Motion Test

  Prior to each treatment session, on average 3 times a week

Study Arms (1)

AMES Treatment

EXPERIMENTAL

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.

Device: AMES Treatment

Interventions

AMES Treatment 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).

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:

• 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

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), 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Shepherd Center, Atlanta GA: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Shepherd Center, Crawford Research Center

Atlanta, Georgia, 30309, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.

Results Point of Contact

• Title: Paul Cordo
• Organization: AMES Technology Inc.

pcordo@amesdevices.com

15039706129

Study Officials

• Paul J Cordo, PhD

  Oregon Health and Science University

  STUDY DIRECTOR

• Andrew Nemecek, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Deborah Backus, PT, PhD

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: December 8, 2011
• First Posted: December 26, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 24, 2019
• Results First Posted: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)