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AMES Treatment of the Proximal Arm in Chronic Stroke (AMES)

Primary Purpose

Stroke, Cerebrovascular Accident

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

30 PAAD treatments

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Dyssynergia, Robotics, AMES, Cerebrovascular Accident

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oregon Health and Science University West Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PAAD (Proximal Arm AMES Device)Treatments

Arm Description

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment - Upper Extremity

Secondary Outcome Measures

Ashworth Spasticity Scale

Modified Wolf Motor Test

Full Information

NCT ID

NCT01934439

First Posted

August 26, 2013

Last Updated

March 27, 2019

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01934439

Brief Title

AMES Treatment of the Proximal Arm in Chronic Stroke

Acronym

AMES

Official Title

AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Loss of funding; could not complete building the testing device.

Study Start Date

August 2013 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cerebrovascular Accident

Keywords

Stroke, Rehabilitation, Dyssynergia, Robotics, AMES, Cerebrovascular Accident

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PAAD (Proximal Arm AMES Device)Treatments

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

30 PAAD treatments

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fugl-Meyer Assessment - Upper Extremity

Time Frame

Baseline and change from baseline at 0 and 3 months post completion

Secondary Outcome Measure Information:

Title

Ashworth Spasticity Scale

Time Frame

Baseline and change from baseline at 0 and 3 months post completion

Title

Modified Wolf Motor Test

Time Frame

Baseline and change from baseline at 0 and 3 months post completion

Other Pre-specified Outcome Measures:

Title

Box and Block Test

Time Frame

Baseline and change from baseline at 0 and 3 months post completion

Title

Upper extremity strength of the shoulder and elbow joints

Description

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.

Time Frame

Baseline, after each of 30 treatments, 3 months post completion of all treatments

Title

Reaching Test

Description

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.

Time Frame

Baseline and change from baseline at 0 and 3 months post completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barry Oken, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul J Cordo, Ph.D

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Director

Facility Information:

Facility Name

Oregon Health and Science University West Campus

City

Beaverton

State/Province

Oregon

ZIP/Postal Code

97006

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18645190

Citation

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.

Results Reference

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AMES Treatment of the Proximal Arm in Chronic Stroke

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