Patient Targeted Upper Extremity Rehabilitation After Stroke (TARG)

This study is currently recruiting participants.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01819506
First received: March 11, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. This study will investigate the effects of a challenging 4-week physical rehabilitation therapy program that is targeted at specific movement impairments and systematically progressed to assure an ongoing "just right" level of rigor. The investigators anticipate that therapy targeted to address specific movement impairments will improve recovery of arm/hand movement in people who have had a stroke.


Condition Intervention
Stroke
Behavioral: Task Practice Physical Rehabilitation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient-Targeted Upper Extremity Rehabilitation After Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fugl-Meyer Upper Extremity Assessment Rasch Analysis Person-Measure [ Time Frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. ] [ Designated as safety issue: No ]
    The Fugl-Meyer Upper Extremity Assessment (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is traditionally scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Instead of this traditional scoring method, we will transform patients' responses to the voluntary movement items into a measure of patient-ability with Rasch analysis.


Secondary Outcome Measures:
  • Kinematic Analysis of Functional Arm Movement [ Time Frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. ] [ Designated as safety issue: No ]
    Kinematic analysis is an objective method to study functional arm movement abilities. Subjects will be fitted with 40 small LED diodes. With the paretic arm, study participants will perform 10 trials of reach-to-grasp (or touch) a soda can placed at a location equal to 80% of arm's length away from the body, a location affording maximum shoulder flexion and elbow extension. Subjects will be safely seated during this assessment. Kinematic data will be recorded with a 10-sensor PhaseSpace motion analysis system and processed with custom ORBIS motion capture software.

  • Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations [ Time Frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. ] [ Designated as safety issue: No ]
    sEMG analysis is an objective method to study muscle coordination during functional arm movements. Subjects will be fitted with sensors on the skin placed over 8 arm/shoulder muscles on both arms. The sensors will detect the muscle activity of these muscles during functional reaching movements. sEMG data will be recorded with a 16-channel wireless Motion Labs EMG system and processed with custom ORBIS software.


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Targeted Task Practice
Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability.
Behavioral: Task Practice Physical Rehabilitation Therapy
Similar to stroke rehabilitation occupational therapy.
Other Name: Task Practice
Active Comparator: Non-Targeted Task Practice
Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy.
Behavioral: Task Practice Physical Rehabilitation Therapy
Similar to stroke rehabilitation occupational therapy.
Other Name: Task Practice

Detailed Description:

The overwhelming majority of individuals who survive stroke have persistent upper extremity (UE) motor deficits which interfere with re-engagement in meaningful activities. While advances from neuroscience are spurring development of new rehabilitation strategies, the development of novel measurement methods has not kept pace. Currently, there is no comprehensive measurement framework to objectively quantify impairment, match a rehabilitation therapy program to a patient's impairment level, and measure specific therapy effects. Therefore there has not been a rehabilitation trial where a measurement framework is the basis for designing the treatment as well as defining the outcome. The investigators redesigned the Fugl-Meyer UE Assessment (FMA-UE) using item response theory Rasch analysis and developed a first of its kind measurement framework that locates a patient along a continuum of impairment and directs a personalized therapy program tailored to patients' specific impairments and ability levels. The purpose of this proposed research is to empirically test this framework.

The objective of this project is to empirically test the FMA-UE measurement framework.

This study hypothesizes that therapeutic task practice at the just-right challenge of difficulty will maximize post-stroke motor skill reacquisition. It is expected that "targeted task-practice", will increase UE motor ability because task goal difficulty will be matched and systematically progressed according to patients' initial and evolving levels of ability.

This is a single-blinded study with parallel arm design, stratified sampling and blocked randomization. 120 individuals with post-stroke UE hemiparesis will be enrolled; 40 participants per 3 UE impairment levels as defined by our measurement framework. Participants will engage in 12 sessions (3x/wk for 4 weeks, 2 hrs/session) of reach-to-grasp task-practice. Within each impairment level, subjects will be randomized to a treatment group; 20 to targeted task-practice and 20 to non-targeted task-practice. Targeted task-practice is personalized to patient-specific UE motor deficits with initial targets (goals) defined according to baseline measures and targets continually progressed after every 3 therapy sessions so that the goals match the patient's evolving level of ability. Non-targeted task practice is defined as a standard of care task-practice intervention intended to increase UE use but not alter specific impairments. Data analyses will include (1) ANOVA to test the effects of targeted vs. non-targeted therapy on UE motor ability, (2) multiple regression to model the relationship between therapy and movement adaptions occurring pre- to post-rehabilitation, and (3) growth mixture modeling to define responders and non-responders.

This project is significant because there is a pressing need for a comprehensive measurement framework to guide novel interventions designed to improve post-stroke UE motor function and define their effects.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Individuals are eligible for this study if they have:

  • experienced unilateral hemispheric ischemic stroke at least 6 months but no more than 7 years prior.
  • exhibit voluntarily paretic arm shoulder flexion 30 degrees with simultaneous elbow extension 20 degrees.
  • impairment with overhead reach and wrist circumduction and fine motor dexterity.
  • passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Exclusion Criteria:

Individuals are not eligible for this study if they have:

  • a lesion in the brainstem or cerebellum.
  • another neurological disease that may impair motor skills (e.g., Parkinson's Disease).
  • pain in the affected shoulder, elbow or wrist that interferes with movement.
  • difficulty understanding and following 3-step directions.
  • difficulty sitting independently without postural support.
  • an orthopedic condition or impaired corrected vision that alters the kinematics of reaching.
  • are unable to travel to and remain in Charleston SC for the duration of the 4-week study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819506

Contacts
Contact: Michelle L Woodbury, PhD (834) 792-1671 WoodbuML@musc.edu
Contact: Andrew N Fortune, BS (843) 792-8970 fortunea@musc.edu

Locations
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Michelle L Woodbury, PhD    (834) 792-1671    WoodbuML@musc.edu   
Principal Investigator: Michelle Lynne Woodbury, PhD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Michelle Lynne Woodbury, PhD Ralph H. Johnson VA Medical Center, Charleston, SC
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01819506     History of Changes
Other Study ID Numbers: N0799-R
Study First Received: March 11, 2013
Last Updated: January 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
rehabilitation
occupational therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 23, 2014