Stroke
Conditions
Keywords
rehabilitation, occupational therapy, upper extremity
Brief 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.
Interventions
BEHAVIORALTask Practice Physical Rehabilitation Therapy
Similar to stroke rehabilitation occupational therapy.
Sponsors
Medical University of South Carolina
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of the Upper Extremity | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. | 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. |
| Wolf Motor Function Test | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations | participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks. | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited from a University Stroke Rehabilitation Research Registry.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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. | 52 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 5 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | MATCH Targeted Task Practice | Total | Usual Care: Non-Targeted Task Practice |
|---|---|---|---|
| Age, Continuous | 55.47 years STANDARD_DEVIATION 12.61 | 55.53 years STANDARD_DEVIATION 12.83 | 57.58 years STANDARD_DEVIATION 13.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 32 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 70 Participants | 37 Participants |
| Region of Enrollment United States | 51 Participants | 103 Participants | 52 Participants |
| Sex: Female, Male Female | 20 Participants | 45 Participants | 25 Participants |
| Sex: Female, Male Male | 31 Participants | 58 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 5 / 51 | 1 / 52 |
| serious Total, serious adverse events | 1 / 51 | 1 / 52 |
Outcome results
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.
Time frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MATCH Targeted Task Practice | Fugl-Meyer Assessment of the Upper Extremity | 4.08 score on a scale | Standard Deviation 4.39 |
| Usual Care: Non-Targeted Task Practice | Fugl-Meyer Assessment of the Upper Extremity | 2.45 score on a scale | Standard Deviation 4.34 |
p-value: 0.912ANOVA
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.
Time frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MATCH Targeted Task Practice | Wolf Motor Function Test | -4.81 seconds | Standard Deviation 8.4 |
| Usual Care: Non-Targeted Task Practice | Wolf Motor Function Test | -6.51 seconds | Standard Deviation 18.85 |
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.
Time frame: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
Population: Complete and accurate data for this measure is no longer available.