NCT01116544

Treatment of Chronic Stroke With AMES + EMG Biofeedback

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: AMES Technology · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG biofeedback.

Detailed description

Over the last 20 years, the discovery of cortical plasticity in the adult human brain has led to the development of new therapies to rehabilitate stroke survivors whose recovery of motor function has stalled with conventional therapeutic methodology. However, the efficacy of these new therapies appears to be limited to relatively high-functioning chronic stroke patients. A therapeutic approach that may be efficacious in restoring functional movement to low-functioning chronic stroke patients is "AMES," which stands for Assisted Movement with Enhanced Sensation. Despite the efficacy of AMES in restoring movement to low-functioning hemiparetic stroke patients, those with plegia at a joint tend not to recover movement in the plegic direction with AMES treatment or with other rehabilitation therapies. The objective of this study is to determine if AMES treatment in combination with biofeedback can be helpful in restoring functional movement to plegic stroke patients.

Conditions

• Stroke
• Plegia
• Paresis
• Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	AMES Therapy (assisted movement and enhanced sensation)	Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.

Timeline

• Start date: 2007-09-21
• Primary completion: 2011-02-28
• Completion: 2011-02-28
• First posted: 2010-05-05
• Last updated: 2019-11-18
• Results posted: 2019-11-18

Locations

3 sites across 1 country: United States