Patient Targeted Upper Extremity Rehabilitation After Stroke
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 89 |
Updated: | 8/25/2017 |
Start Date: | March 1, 2013 |
End Date: | March 31, 2017 |
Patient-Targeted Upper Extremity Rehabilitation After Stroke
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.
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.
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.
(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.
Inclusion Criteria:
Individuals are eligible for this study if they have:
- experienced a stroke at least 3 months prior that has resulted in unilateral
hemiparesis.
- 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 upper extremity that would limit participation in the study
intervention.
- 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.
We found this trial at
1
site
Charleston, South Carolina 29401
Principal Investigator: Michelle Lynne Woodbury, PhD
Phone: (834) 792-1671
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