AMES Treatment of the Proximal Arm in Chronic Stroke

NCT01934439 | Withdrawn Phase 1 DMC

• 2 other identifiers: IRB00009262OCF9009196
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Cerebrovascular Accident

Keywords

Stroke; Rehabilitation; Dyssynergia; Robotics; AMES; Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity

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

Secondary Outcomes (2)

• Ashworth Spasticity Scale

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

• Modified Wolf Motor Test

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

Other Outcomes (3)

• Box and Block Test

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

• Upper extremity strength of the shoulder and elbow joints

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

• Reaching Test

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

Study Arms (1)

PAAD (Proximal Arm AMES Device)Treatments

EXPERIMENTAL

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.

Device: 30 PAAD treatments

Interventions

30 PAAD treatments DEVICE

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.

PAAD (Proximal Arm AMES Device)Treatments

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University West Campus

Beaverton, Oregon, 97006, United States

Location

Related 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.

  PMID: 18645190 BACKGROUND

MeSH Terms

Conditions

Stroke; Ataxia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry Oken, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Paul J Cordo, Ph.D

  Oregon Health and Science University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 4, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

US (1)