AMES Treatment of the Impaired Leg in Chronic Stroke Patients

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Stroke, Cerebrovascular Accident, Hemiparesis

In brief

The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).

Key facts

Study ID

NCT01378637

Run by

AMES Technology

People needed

22

Starts

2011-01-01

Expected to finish

2017-07-01

Last updated by the study team

2016-12-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Spastic hemiparesis
• At least 12 months post-stroke
• Can comfortably fit foot in treatment device
• Functioning proprioception
• Fugl-Meyer LE score >6 and <23
• Minimal hemi-neglect
• Observable volitional movement of the ankle in either plantar- or dorsi-flexion
• Cognitively and behaviorally capable of complying with the regimen

You may not qualify if…

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

Where it is running

• Northwestern University/Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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