Does More Practice Improve Arm Movement After Stroke?
Dose Response of Movement Practice During Stroke Rehabilitation
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Missouri
-
St. Louis, Missouri, Stany Zjednoczone, 63108
- Washington University School of Medicine
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Low Movement Dose, 3200 total reps
he 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.
|
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.
|
|
Eksperymentalny: Medium Movement Dose, 6400 total reps
he 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.
|
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.
|
|
Eksperymentalny: High Movement Dose, 9600 total reps
he 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.
|
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.
|
|
Eksperymentalny: Individual Maximum High Movement Dose
he 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Action Research Arm Test (ARAT) Score Per Week
Ramy czasowe: 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.
|
9 weeks
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Catherine E Lang, PT, PhD, Washington University School of Medicine
Publikacje i pomocne linki
Publikacje ogólne
- Bailey RR, Lang CE. Upper-limb activity in adults: referent values using accelerometry. J Rehabil Res Dev. 2013;50(9):1213-22. doi: 10.1682/JRRD.2012.12.0222.
- Urbin MA, Hong X, Lang CE, Carter AR. Resting-state functional connectivity and its association with multiple domains of upper-extremity function in chronic stroke. Neurorehabil Neural Repair. 2014 Oct;28(8):761-9. doi: 10.1177/1545968314522349. Epub 2014 Feb 18.
- Bailey RR, Klaesner JW, Lang CE. An accelerometry-based methodology for assessment of real-world bilateral upper extremity activity. PLoS One. 2014 Jul 28;9(7):e103135. doi: 10.1371/journal.pone.0103135. eCollection 2014.
- Urbin MA, Waddell KJ, Lang CE. Acceleration metrics are responsive to change in upper extremity function of stroke survivors. Arch Phys Med Rehabil. 2015 May;96(5):854-61. doi: 10.1016/j.apmr.2014.11.018. Epub 2014 Dec 9. Erratum In: Arch Phys Med Rehabil. 2016 Jan;97(1):178.
- Urbin MA, Bailey RR, Lang CE. Validity of body-worn sensor acceleration metrics to index upper extremity function in hemiparetic stroke. J Neurol Phys Ther. 2015 Apr;39(2):111-8. doi: 10.1097/NPT.0000000000000085.
- Bailey RR, Birkenmeier RL, Lang CE. Real-world affected upper limb activity in chronic stroke: an examination of potential modifying factors. Top Stroke Rehabil. 2015 Feb;22(1):26-33. doi: 10.1179/1074935714Z.0000000040. Epub 2015 Jan 21.
- Bailey RR, Klaesner JW, Lang CE. Quantifying Real-World Upper-Limb Activity in Nondisabled Adults and Adults With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):969-78. doi: 10.1177/1545968315583720. Epub 2015 Apr 20.
- Waddell KJ, Birkenmeier RL, Bland MD, Lang CE. An exploratory analysis of the self-reported goals of individuals with chronic upper-extremity paresis following stroke. Disabil Rehabil. 2016;38(9):853-7. doi: 10.3109/09638288.2015.1062926. Epub 2015 Jul 6.
- Lang CE, Lohse KR, Birkenmeier RL. Dose and timing in neurorehabilitation: prescribing motor therapy after stroke. Curr Opin Neurol. 2015 Dec;28(6):549-55. doi: 10.1097/WCO.0000000000000256.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 10-0230
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .