Cerebrovascular Accident, Hemiparesis, Stroke
Conditions
Keywords
Leg, Robotic device, AMES, Stroke, Cerebrovascular Accident, Rehabilitation
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.
Interventions
DEVICEAMES- Leg treatment
30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible.
Sponsors
Oregon Health and Science University
Northwestern University
Shirley Ryan AbilityLab
National Institute of Neurological Disorders and Stroke (NINDS)
AMES Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Motor Assessment of the Lower Affected Extremity | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments | Measurement of spasticity in the ankle joint. |
| Dynamic Balance/Weight Distribution | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments | Measure the subject's right-left weight distribution and dynamic balance control. |
| Gait Assessment | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments | The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test. |
| Passive Motion Test | Prior to each treatment session | Measures the peak resistance in the affected ankle. |
| Active Range of Motion Test | Prior to each treatment session | A joint tracking task guided by visual feedback on a computer screen. |
| Ankle Strength | Prior to each treatment session, | Measurement of three attempts of dorsiflexion and three attempts of plantarflexion. |
Countries
United States
Outcome results
None listed