Clinical trial NCT01378637: AMES Treatment of the Impaired Leg in Chronic Stroke Patients
Official title: AMES Treatment of the Impaired Leg in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Cerebrovascular Accident
Hemiparesis
Keywords: Leg
Robotic device
AMES
Stroke
Cerebrovascular Accident
Rehabilitation
Lead sponsor: AMES Technology
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
name: Northwestern University
name: Shirley Ryan AbilityLab
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2011-06-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, are not brought to a level of maximal recovery. The aims of the proposed project are to obtain a set of data from a total of 20 chronic stroke subjects, all with severe lower extremity disability, between the ages of 18-85, using a robotic therapeutic device placed in a rehabilitation clinic. This data will allow us to quantify the extent to which a combination of robotic-assisted exercise and tendon vibration from the AMES beta device induces secondary recovery from the effects of stroke on the lower extremity.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fugl-Meyer Motor Assessment of the Lower Affected Extremity
timeFrame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
Secondary outcomes:
measure: Gait Assessment
timeFrame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
measure: Modified Ashworth Scale
timeFrame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
measure: Dynamic Balance/Weight Distribution
timeFrame: Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments
measure: Ankle Strength
timeFrame: Prior to each treatment session,
measure: Passive Motion Test
timeFrame: Prior to each treatment session
measure: Active Range of Motion Test
timeFrame: Prior to each treatment session
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University/Rehabilitation Institute of Chicago
state: Illinois
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry Oken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University/Rehabilitation Institute of Chicago
name: Elliot Roth, MD
role: PRINCIPAL_INVESTIGATOR
References: