Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke
Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Oczekiwany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Taipei, Tajwan
- Rekrutacyjny
- Taipei Medical University Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Patients present with unilateral hemiplegia caused by a first-ever stroke
- Brunnstrom stage above stage II, mental health was stable
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)
Exclusion Criteria:
- Patients having other neurologic problems, which can affect balance and walking ability
- Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
- severe hearing or eye problem
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Augmented reality with functional electrical stimulation group
Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks.
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Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy.
Augmented reality includes treadmill and balance exercise.
Functional electrical stimulation applies on tibialis anterior muscle.
Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.
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Aktywny komparator: Traditional physiotherapy group
Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks.
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Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change of Time Up Go test (TUG)
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Berg Balance Scale (BBS)
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance.
Each task was scored on a 5-point ordinal scale (from 0 to 4).
A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion.
The highest possible score is 56.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Functional magnetic resonance imaging (fMRI)
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Our study will use 3 Tesla magnetic resonance imaging[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)] for functional magnetic resonance imaging.
Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters.
The EPI scan for 525 seconds.
All subjects are asked to close their eyes and supine.
our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control.
Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance).
The total score range from 0 (no motor function) to 34 (good motor recovery).
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Modified Ashworth Scale (MAS)
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows: 0: No increase in muscle tone
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Motor evoked potential (MEP)
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex.
All TMS is delivered with the participant seated upright on the chair.
Both passive and active conditions, participants are instructed to relax their right leg in the seated position.
TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom).
To locate the optimal site, stimuli are delivered over various points along the M1.
The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles.
The onset latency and onset to peak amplitude will be assessed.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of 10 meter walking test
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Individual walks without assistance 10 meters and the time is measured.
Participants will walk 10 meter at preferred walking speed and fastest speed possible, respectively.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Change of Diffusion Tensor Imaging (DTI)
Ramy czasowe: Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Diffusion tensor imaging technique apply to Echo-Planar Image(EPI) technique, fimbriodentate vein is 192X192 mm², time of repetition/time of echo is 11000/110.6
mm, matrix is 72X72 pixels, slice thickness is 2.7 mm. Diffusion weight gradient along 60 directions at b value of 3000/mm².
By observing the reduction of the degree of diffusion anisotropy, to study the recovery of motor function after stroke.
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Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Zakończenie podstawowe
Ukończenie studiów (Oczekiwany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- N201904041
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
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