Spinal Cord Injury Leg Rehabilitation

Spinal Cord Injury Clinical Trial

— AMES  

Official title:

Rehabilitation of the Lower Extremity With AMES Following Incomplete Spinal Cord Injury (SCI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01498991
• Other study ID #: IRB00007762
• Secondary ID: R01NS061304-22
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 2011
• Est. completion date: November 2016

Study information

• Verified date: May 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia
• Wounds and Injuries

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Shepherd Center, Crawford Research Center	Atlanta	Georgia
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Neurological Disorders and Stroke (NINDS), Shepherd Center, Atlanta GA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	Gait Assessment Including Step Length and Cadence	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	Ankle Active Motion Test	The participants will perform an active range-of-motion (ROM) task each time they are treated with the AMES device, in which they move the affected joint to several target joint angles, guided by visual feedback on a display screen on the AMES device.	Prior to each treatment session, on average 3 times a week
Secondary	Ankle Strength	The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction .	Prior to each treatment session, on average 3 times a week
Secondary	ASIA Motor and Sensory Scores for L2-S1		Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).