Patient Targeted Upper Extremity Rehabilitation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      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.
    

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 the investigators' 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.
    

Intervention name(s): Task Practice Physical Rehabilitation Therapy
Intervention type(s): Behavioral
Intervention description(s): Similar to stroke rehabilitation occupational therapy.
Other intervention name(s): Task Practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; occupational therapy; upper extremity