AMES Treatment of the Proximal Arm in Chronic Stroke

Stroke Clinical Trial

— AMES  

Official title:

AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01934439
• Other study ID #: IRB00009262
• Secondary ID: OCF9009196
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects will receive 30 treatments with AMES, to the proximal arm which has been affected by a chronic stroke.

Description:

This study seeks to determine whether 30 treatments with AMES, to the proximal affected arm of subjects with chronic stroke, will improve subjects' proximal arm active range-of-motion. We hypothesize that the combination of assisted movement, torque biofeedback, and muscle vibration will reduce impairment (i.e., increase strength and range-of-motion; decrease inappropriate patterns of muscle contraction) and, thereby, lead to more accurate reaching with the proximal arm.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ischemic or Hemorrhagic stroke affecting the right arm

• One year or longer since stroke

• Severe impairment of right arm with a baseline upper extremity Fugl-Meyer score between 8-24

• Right elbow and shoulder spasticity (Ashworth score =3)

• Right shoulder abduction-elbow flexion dyssynergia

Exclusion Criteria:

• Exercise intolerance

• Co-morbidities limiting arm movement (e.g. shoulder subluxation)

• Chronic pain

• Cognitive dysfunction preventing compliance with instructions

• Participation in other ongoing research studies

• Plans to initiate or discontinue any physical/occupational therapy during the period of enrollment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• 30 PAAD treatments
Subjects will don a shirt with pockets at the elbow and shoulder in each of which a muscle vibrator is located. The subject will then place the affected arm in the PAAD. The PAAD will range the affected arm, at the shoulder in the adduction-abduction direction, and at the elbow in the flexion-extension direction. The subject will assist volitionally this motion, and visual feedback of the level of their assistive torque will be provided along with a target torque level. The muscle vibrators will alternate from one side of each of the 2 joints to the other as the motion reverses, vibration always being applied to the lengthening muscles. This treatment will last 30 min in each session.

Locations

Country	Name	City	State
United States	Oregon Health and Science University West Campus	Beaverton	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Box and Block Test		Baseline and change from baseline at 0 and 3 months post completion
Other	Upper extremity strength of the shoulder and elbow joints	The PAAD measures the strength at the elbow and shoulder by recording the torque applied by the subject to the device with the elbow and shoulder during maximal efforts.	Baseline, after each of 30 treatments, 3 months post completion of all treatments
Other	Reaching Test	In the Reaching Test, a video system will test each participant's pointing accuracy and smoothness of transportation of the arm to reach specific targets.	Baseline and change from baseline at 0 and 3 months post completion
Primary	Fugl-Meyer Assessment - Upper Extremity		Baseline and change from baseline at 0 and 3 months post completion
Secondary	Ashworth Spasticity Scale		Baseline and change from baseline at 0 and 3 months post completion
Secondary	Modified Wolf Motor Test		Baseline and change from baseline at 0 and 3 months post completion