Stroke
Conditions
Keywords
stroke, upper extremity, paresis, function, translational research
Brief summary
Arm weakness happens a lot after a stroke. People often get physical or occupational therapy after their stroke to learn how to use their arm again. This study will help figure out how much therapy should be given to restore as much arm function as possible.
Detailed description
Dose has emerged as a key factor promoting functional recovery after stroke. Currently, a lack of data on the dose-response relationship impedes progress in the field of stroke rehabilitation. The goal of the proposed project is to define the range of doses of movement practice that produce the greatest improvements in outcomes in people with chronic stroke. Borrowing from animal models of stroke, dose in humans can be quantified by the number of repetitions of task-specific practice. Our central hypothesis is that there exists a range of doses for people with stroke, below which, there is minimal benefit, and above which, further practice does not result in further benefit. The range of beneficial doses is likely to vary based on the severity of motor deficits and the presence of non-motor deficits in other domains. Using a randomized, parallel dose-response design, we will evaluate the benefits of four different doses of task-specific upper extremity training with matched schedules of 1 hr sessions, 4 sessions/wk for 8 wks, in 100 people with chronic stroke. Total repetition doses to be evaluated (3200, 6400, 9600, & individualized-maximum) are based on our preliminary data. The individualized-maximum group may extend their sessions beyond 8 wks until meeting defined stop criteria. Our primary aim will test whether larger total doses result in better outcomes than smaller total doses. Benefits of the four doses will be evaluated at the impairment, activity, and participation levels, since understanding the dose-response relationship at all levels of measurement is critical for advancing rehabilitation research. We hypothesize that improvements will be greatest in the 9600 and individualized-maximum, followed by the 6400, and then the 3200 repetition dose groups. Our secondary aim is to characterize the dose-response relationship of upper extremity task-specific practice. With data from multiple assessment points, individual curve modeling will be used to estimate dose ranges, below which, there is minimal benefit, and above which, further practice does not result in further benefit. Furthermore, we will determine how various factors modify the dose estimates. We hypothesize that the severity of motor deficits will be the primary modifier of the dose-response relationship, with larger doses needed for those with more mild motor deficits. We further expect that needed doses will be larger for those with depression and hemispatial neglect. Our team is well-positioned to investigate the critical issue of dose because of our expertise in stroke rehabilitation research and measurement, our understanding of the challenges of clinical practice and clinical research, and our ready access to this patient population. Expected outcomes from this project are empirically-driven estimates indicating the amount of movement practice required to drive maximal improvements and how these estimates can be individually modified for people undergoing stroke rehabilitation. Our estimates will immediately impact rehabilitation research and clinical practice. The importance of this project transcends stroke rehabilitation; our primary results will be of high value to many other rehabilitation populations also impeded by the lack of knowledge regarding dose-response relationships.
Interventions
OTHERIntensive task-specific upper extremity rehabilitation
The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic or hemorrhagic stroke as determined by a stroke neurologist and consistent with neuroimaging * Time since stroke will include subjects 6-months or more post-stroke * Cognitive skills to actively participate (score of 0-1 on items 1b and 1c of the NIH Stroke Scale (NIHSS) * Unilateral upper extremity weakness (score of 1-3 on item 5 (arm item) on the NIHSS)
Exclusion criteria
* Subject unavailable for 2-month follow-up * Inability to follow-2-step commands * Psychiatric diagnoses * Current participation in other stroke treatment (i.e.- Botox) * Other neurological diagnoses * If participant lives further than one hour away and is unwilling to travel for assessment and treatment sessions. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Action Research Arm Test (ARAT) Score Per Week | 9 weeks | The Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Movement Dose, 3200 Total Reps Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to. | 20 |
| Medium Movement Dose, 6400 Total Reps Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to. | 21 |
| High Movement Dose, 9600 Total Reps Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to. | 21 |
| Individual Maximum High Movement Dose Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to. | 20 |
| Total | 82 |
Baseline characteristics
| Characteristic | Low Movement Dose, 3200 Total Reps | Medium Movement Dose, 6400 Total Reps | High Movement Dose, 9600 Total Reps | Individual Maximum High Movement Dose | Total |
|---|---|---|---|---|---|
| Affected side Left | 9 Participants | 11 Participants | 11 Participants | 7 Participants | 38 Participants |
| Affected side Right | 11 Participants | 10 Participants | 10 Participants | 13 Participants | 44 Participants |
| Age, Continuous | 59.9 years STANDARD_DEVIATION 12.8 | 62.1 years STANDARD_DEVIATION 8.6 | 60.0 years STANDARD_DEVIATION 8.3 | 60.9 years STANDARD_DEVIATION 13.4 | 60.7 years STANDARD_DEVIATION 10.8 |
| Dominant side Left | 2 Participants | 5 Participants | 2 Participants | 2 Participants | 11 Participants |
| Dominant side Right | 18 Participants | 16 Participants | 19 Participants | 18 Participants | 71 Participants |
| Gender Female | 7 Participants | 5 Participants | 10 Participants | 8 Participants | 30 Participants |
| Gender Male | 13 Participants | 16 Participants | 11 Participants | 12 Participants | 52 Participants |
| Race/Ethnicity, Customized Race Caucasian | 10 Participants | 11 Participants | 10 Participants | 11 Participants | 42 Participants |
| Race/Ethnicity, Customized Race Non-caucasian | 10 Participants | 10 Participants | 11 Participants | 9 Participants | 40 Participants |
| Region of Enrollment United States | 20 participants | 21 participants | 21 participants | 20 participants | 82 participants |
| Time since stroke | 12 months | 13 months | 13 months | 11.5 months | 12.5 months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 21 | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 21 | 0 / 20 |
Outcome results
Primary
Change in Action Research Arm Test (ARAT) Score Per Week
The Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week.
Time frame: 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Movement Dose, 3200 Total Reps | Change in Action Research Arm Test (ARAT) Score Per Week | 0.4 change in units on a scale/week | Standard Error 0.15 |
| Medium Movement Dose, 6400 Total Reps | Change in Action Research Arm Test (ARAT) Score Per Week | -0.05 change in units on a scale/week | Standard Error 0.21 |
| High Movement Dose, 9600 Total Reps | Change in Action Research Arm Test (ARAT) Score Per Week | 0.31 change in units on a scale/week | Standard Error 0.22 |
| Individual Maximum High Movement Dose | Change in Action Research Arm Test (ARAT) Score Per Week | 0.66 change in units on a scale/week | Standard Error 0.2 |
Comparison: The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.p-value: 0.01Mixed Models Analysis
Comparison: This analysis then asked which groups were different from the Low Movement Dose groupp-value: 0.036t-test, 2 sided
Comparison: This analysis asked if the Low Movement Dose group was different from the High Movement Dose groupp-value: 0.679t-test, 2 sided
Comparison: This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose groupp-value: 0.209t-test, 2 sided