Clinic-Based AMES Treatment of Stroke

Stroke Clinical Trial

Official title:

Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00847704
• Other study ID #: IRB 4005
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 18, 2009
• Last updated: December 17, 2009
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2009
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• 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.
• Assisted movement and enhanced sensation
Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	AMES Technology

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment of the Lower Extremity		0 months, 3 months, and 6 months	No
Secondary	Gait Assessment		0 months, 3 month, and 6 months	No
Secondary	Stroke Impact Scale		0 months, 3 months, and 6 months	No
Secondary	Spasticity (Modified Ashworth) Scale		0 months, 3 months, and 6 months	No
Secondary	Biodex Isokinetic Strength Measurements		0 months, 3 months, and 6 months	No
Secondary	Strength Test		Prior to each treatment session	No
Secondary	Joint Position Test		Prior to each treatment session	No
Secondary	Passive Motion Test		Prior to each treatment session	No

External Links

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