AMES Treatment of the Proximal Arm in Chronic Stroke

Phase 1

Withdrawn

• Conditions: Cerebrovascular Accident; Stroke
• Interventions: Device: 30 PAAD treatments

• Registration Number: NCT01934439
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAAD (Proximal Arm AMES Device)Treatments	30 PAAD treatments	The PAAD flexes and extends the elbow, and it abducts and adducts the shoulder, where "abduction" is away from the side of the body, and "adduction" is towards it. Elbow extension occurs simultaneously with shoulder abduction, and elbow flexion occurs simultaneously with shoulder adduction. At the same time as the movements, vibrators are utilized to activate muscle spindle Ia receptors in the muscles of the arm to exaggerate the perception of movement.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment - Upper Extremity	Baseline and change from baseline at 0 and 3 months post completion

Secondary Outcome Measures

Name	Time	Method
Modified Wolf Motor Test	Baseline and change from baseline at 0 and 3 months post completion
Ashworth Spasticity Scale	Baseline and change from baseline at 0 and 3 months post completion

Trial Locations

Locations (1)

Oregon Health and Science University West Campus; 🇺🇸 Beaverton, Oregon, United States