AMES Treatment of the Impaired Leg in Chronic Stroke Patients

Stroke Clinical Trial

— AMES  

Official title:

AMES Treatment of the Impaired Leg in Chronic Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01378637
• Other study ID #: 7034
• Secondary ID: R44NS060192-03
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 18, 2011
• Last updated: December 7, 2016
• Start date: January 2011
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: AMES Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hemiparesis
• Paresis
• Stroke

Intervention

Device:
• AMES- 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.

Locations

Country	Name	City	State
United States	Northwestern University/Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
AMES Technology	National Institute of Neurological Disorders and Stroke (NINDS), Northwestern University, Oregon Health and Science University, Rehabilitation Institute of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Gait Assessment	The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test.	Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments	No
Secondary	Modified Ashworth Scale	Measurement of spasticity in the ankle joint.	Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments	No
Secondary	Dynamic Balance/Weight Distribution	Measure the subject's right-left weight distribution and dynamic balance control.	Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments	No
Secondary	Ankle Strength	Measurement of three attempts of dorsiflexion and three attempts of plantarflexion.	Prior to each treatment session,	No
Secondary	Passive Motion Test	Measures the peak resistance in the affected ankle.	Prior to each treatment session	No
Secondary	Active Range of Motion Test	A joint tracking task guided by visual feedback on a computer screen.	Prior to each treatment session	No