Clinic-Based AMES Treatment of Stroke

NCT ID: NCT00847704

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-11-30

Brief Summary

This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.

Detailed Description

The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.

Conditions

Stroke; Cerebrovascular Accident

Study Design

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

Study Groups

Test treatment group

Device: Assisted movement and enhanced sensation

Group Type: EXPERIMENTAL

Assisted movement and enhanced sensation

Intervention Type: DEVICE

Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.

Interventions

Assisted movement and enhanced sensation

Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least 12 months post-stroke
• Cognitively and behaviorally capable of complying with the regimen
• Functioning proprioception
• Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices

Exclusion Criteria

• Fractures of treated limb resulting in loss of range of motion
• Spinal cord injury
• Deep vein thrombosis
• Peripheral nerve injury or neuropathy in the limb affected with motor disability
• Osteoarthritis limiting range of motion
• Skin condition not tolerant of device
• Progressive neurodegenerative disorder
• Uncontrolled seizure disorder
• Botox treatment within the last 5 months
• Baclofen pump

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AMES Technology

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Cordo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J. Cordo, PhD

Role: PRINCIPAL_INVESTIGATOR

AMES Technology Inc./Oregon Health and Science University

Locations

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: BACKGROUND

PMID: 18645190 (View on PubMed)

Other Identifiers

IRB 4005

Identifier Type: -

Identifier Source: org_study_id

NCT00600184

Identifier Type: -

Identifier Source: nct_alias