Clinical trial NCT01934439: AMES Treatment of the Proximal Arm in Chronic Stroke
Official title: AMES Rehabilitation of the Proximal Arm in Severely Impaired Stroke Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Stroke
Cerebrovascular Accident
Keywords: Stroke
Rehabilitation
Dyssynergia
Robotics
AMES
Cerebrovascular Accident
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl-Meyer Assessment - Upper Extremity
timeFrame: Baseline and change from baseline at 0 and 3 months post completion
Secondary outcomes:
measure: Ashworth Spasticity Scale
timeFrame: Baseline and change from baseline at 0 and 3 months post completion
measure: Modified Wolf Motor Test
timeFrame: Baseline and change from baseline at 0 and 3 months post completion
Other outcomes:
measure: Box and Block Test
timeFrame: Baseline and change from baseline at 0 and 3 months post completion
measure: Upper extremity strength of the shoulder and elbow joints
timeFrame: Baseline, after each of 30 treatments, 3 months post completion of all treatments
measure: Reaching Test
timeFrame: Baseline and change from baseline at 0 and 3 months post completion
Locations:
city: Beaverton
country: United States
facility: Oregon Health and Science University West Campus
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry Oken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Paul J Cordo, Ph.D
role: STUDY_DIRECTOR
References:
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.