NCT01378637

AMES Treatment of the Impaired Leg in Chronic Stroke Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: AMES Technology · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Cerebrovascular Accident
• Hemiparesis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-12-01
• Completion: 2017-07-01
• First posted: 2011-06-22
• Last updated: 2016-12-08

Locations

2 sites across 1 country: United States