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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01934439
Other study ID # IRB00009262
Secondary ID OCF9009196
Status Withdrawn
Phase Phase 1
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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