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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Task Practice | Experimental | 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. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length. |
|
| Non-Targeted Task Practice | Active Comparator | 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. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Task Practice Physical Rehabilitation Therapy | Behavioral | Similar to stroke rehabilitation occupational therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment of the Upper Extremity | The Fugl-Meyer Assessment of the Upper Extremity (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, the investigators will eliminate the reflex items, thus reporting the aggregate score possible from 0/60 to 60/60 points. Higher scores indicate greater levels of arm movement ability. | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. |
| Wolf Motor Function Test | The Wolf Motor Function Test is an assessment of arm movement function. Subjects are timed (seconds) as they complete 15 functional movements with the paretic arm. The average time required to complete an item is reported in seconds so that lower scores (quicker completion times) indicate greater functional movement skills. Post-intervention averages were compared to baseline averages so a reduction in timed averages indicates improved movement function. | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations | 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. |
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Inclusion Criteria:
Individuals are eligible for this study if they have:
Exclusion Criteria:
Individuals are not eligible for this study if they have:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle L. Woodbury, PhD | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17532892 | Background | Woodbury ML, Velozo CA, Richards LG, Duncan PW, Studenski S, Lai SM. Dimensionality and construct validity of the Fugl-Meyer Assessment of the upper extremity. Arch Phys Med Rehabil. 2007 Jun;88(6):715-23. doi: 10.1016/j.apmr.2007.02.036. | |
| 22234665 | Background | Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203. |
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Recruited from a University Stroke Rehabilitation Research Registry.
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| ID | Title | Description |
|---|---|---|
| FG000 | MATCH | MATCH is defined as a task-practice occupational therapy program targeting patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy. |
| FG001 | Usual Care | Usual Care is defined as a non-targeted task practice standard of care occupational therapy program consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MATCH 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. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fugl-Meyer Assessment of the Upper Extremity | The Fugl-Meyer Assessment of the Upper Extremity (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, the investigators will eliminate the reflex items, thus reporting the aggregate score possible from 0/60 to 60/60 points. Higher scores indicate greater levels of arm movement ability. | Posted | Mean | Standard Deviation | score on a scale | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. |
|
An expected average of 4 weeks
All-cause Mortality was not monitored/addressed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MATCH 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. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| subsequent stroke | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Fell on bus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Woodbury | Ralph H Johnson VAMC | 843-792-1671 | Woodbuml@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2016 | Aug 17, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2016 | Feb 15, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. |
| BG001 |
| Usual Care: 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. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care: 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. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy. |
|
|
|
| Primary | Wolf Motor Function Test | The Wolf Motor Function Test is an assessment of arm movement function. Subjects are timed (seconds) as they complete 15 functional movements with the paretic arm. The average time required to complete an item is reported in seconds so that lower scores (quicker completion times) indicate greater functional movement skills. Post-intervention averages were compared to baseline averages so a reduction in timed averages indicates improved movement function. | Posted | Mean | Standard Deviation | seconds | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. |
|
|
|
| Secondary | Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations | 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. | Complete and accurate data for this measure is no longer available. | Posted | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. |
|
|
| 0 |
| 0 |
| 1 |
| 51 |
| 5 |
| 51 |
| EG001 | Usual Care: 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. Task Practice Physical Rehabilitation Therapy: Similar to stroke rehabilitation occupational therapy. | 0 | 0 | 1 | 52 | 1 | 52 |
| sick | Gastrointestinal disorders | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| cardiac problems | Cardiac disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |