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Skuteczność urządzenia Dynavision w poprawie świadomości przestrzennej po urazie mózgu

30 września 2026 zaktualizowane przez: Teresa Broers

Skuteczność Dynavision D2 w poprawie lewostronnego zaniedbywania u dorosłych z urazem mózgu: randomizowana próba kontrolna

The purpose of this research is to determine the effectiveness of using the Dynavision D2 to improve left neglect in adults with brain injury, and improve performance of ADLs/IADLs. This study will use a randomized control trial at Providence Care Hospital in Kingston Ontario, with clients admitted to the Stroke and ABI services who have been identified through the Catherine Bergego Scale (CBS) as having moderate to severe left neglect. Individuals will be randomly assigned to the control arm, where they will get the usual 60 minutes of OT treatment daily or the intervention arm, which is 30 minutes of their usual OT treatment and a 30 minute session of the Dynavision for 10 sessions for short stay inpatients (~ 3 weeks) and 20 sessions for clients with longer 5-6 week stay. The CBS will be used to measure change in neglect severity at three time points: baseline, following 10 sessions and following 20 sessions, for those that stay for longer.

Przegląd badań

Status

Zakończony

Interwencja / Leczenie

Szczegółowy opis

This study will be a randomized control trial that will take place at Providence Care Hospital in Kingston, Ontario. Eligibility screening will be completed by the OT and written consent will be in person prior to randomization. Individuals will be able to decline participation without impact upon their usual treatment and will be able to withdraw at any time, even if they originally consented to be included. Stratified block randomization will take place, stratified by moderate and severe neglect, to ensure there are equal numbers of moderate and severe in each study arm, given that this pilot study will have a small sample size. The study IDs will be blindly assigned to intervention (Dynavision sessions) and control (usual OT therapy) groups. The study ID information with the respective group allocation will be coordinated by the primary investigator. Treating Occupational Therapists and OT Assistants will carry out the interventions, as per the group allocations.

Participants will be included into the study based on results from the Catherine Bergego Scale (CBS), via the Kessler Foundation Neglect Assessment Process (KF-NAP). This tool will be administered to individuals within the first 3 workdays following admission. Any client who scores moderate or severe on the CBS will be considered for inclusion into the study. Two additional sub tests from the Behavioural Inattention Test (BIT), namely the Star Cancellation Test and the Letter Cancellation Test will also be used in individuals identified by the CBS to have moderate to severe neglect. The sub-tests from the BIT are crucial to offer a secondary measure of peri-personal inattention, and offers qualitative information regarding if clients are using an efficient left-right strategy to cancel targets or a more inefficient right-left, up-down, or random strategies. Together, the measures will qualify and quantify the degree of impairment pre- and post-intervention.

Individuals will be randomly assigned to the control arm, where they will get usual OT treatment for 60 minutes or the intervention arm that will include a defined treatment period using the Dynavision. Participants assigned to the intervention arm will have 30 minutes of their usual OT treatment session, in addition to a 30-minute session of the Dynavision. It is important for the Dynavision session to not be a session over and above their usual one hour of therapy, as the study aims to determine the utility of the Dynavision to improve neglect, rather than testing increased therapy time in general. Individuals in the control arm will use the Dynavision once per week for only 10-15 minutes - 5 rounds of 2 or 3 minutes, which is similar to what clients have been receiving since we acquired the Dynavision.

For the intervention arm, use of the Dynavision will be comprised of six 3-minute or nine 2-minute sessions with 30 seconds to one-minute rest in between. All Dynavision sessions require clients to scan the 4' by 4' vertical board and hit the lit targets one at a time. Participants will be able to depress targets with their left or right hand, in standing or sitting. There are several programs that can be used to ensure participants stay interested and engaged, and all will require scanning left and right and back to the left. They will receive education about visual scanning, and encouragement to use a "left-right" strategy or, if needed, a "lawn mower" strategy, to help them to scan left. Testing will take place at three points: three-four days after admission will be the baseline score for all clients, at three weeks, following 10 sessions of the Dynavision, and finally at 5-6 weeks, after 20 sessions of the Dynavision. This means all patients will be tested at 10 weeks, and the longer stay patients will have an additional test score at 20 weeks.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

4

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Ontario
      • Kingston, Ontario, Kanada, K7L 4X3
        • Providence Care Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Inpatient on stroke or acute brain injury service
  • Medically stable
  • Moderate-to-severe neglect, as determined by the Catherine Bergego Scale
  • Motivated to participate in daily therapy
  • Can physically and cognitively tolerate up to three hours of daily therapy from Occupational Therapy, Physiotherapy, and Speech Therapy

Exclusion Criteria:

  • N/A

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

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: Repetitive Visual Scanning Training

Participants will receive 30 minutes of their usual occupational therapy treatment and a 30 minute session of the Dynavision for 10 sessions for short stay inpatients (~ 3 weeks) and 20 sessions for clients with longer 5-6 week stay.

Use of the Dynavision will be comprised of six 3-minute or nine 2-minute sessions with 30 seconds to one-minute rest in between. All Dynavision sessions require clients to scan the 4' by 4' vertical board and hit the lit targets one at a time. Participants will be able to depress targets with their left or right hand, in standing or sitting.

Brak interwencji: Usual Treatment

Participants will receive the standard 60 minutes of occupational therapy treatment.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean change from baseline score on Catherine Bergego Scale after 10 therapy sessions
Ramy czasowe: ~3 weeks from baseline

The Catherine Bergego Scale is a standardized tool to detect presence and degree of neglect during observation of everyday life situations. It is a 10-item scale, with each item, scored from 0-3, measuring no neglect up to severe neglect.

~3 weeks from baseline
Mean change from baseline score on Catherine Bergego Scale after 20 therapy sessions
Ramy czasowe: ~5-6 weeks from baseline

The Catherine Bergego Scale is a standardized tool to detect presence and degree of neglect during observation of everyday life situations. It is a 10-item scale, with each item, scored from 0-3, measuring no neglect up to severe neglect.

~5-6 weeks from baseline

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean change from baseline score on Star Cancellation Test after 10 therapy sessions
Ramy czasowe: ~3 weeks from baseline

The Star Cancellation test is a sub-test from the Behavioural Inattention Test, which aims to assess the presence and the extent of visual neglect. This test consists of a random array of verbal and non-verbal stimuli. The stimuli are 52 large stars (14 mm), 13 randomly positioned letters and 19 short (3-4 letters) words are interspersed with 56 smaller stars (8mm) which comprise the target stimuli. The patient is instructed to cancel all the small stars.

~3 weeks from baseline
Mean change from baseline score on Star Cancellation Test after 20 therapy sessions
Ramy czasowe: ~5-6 weeks from baseline

The Star Cancellation test is a sub-test from the Behavioural Inattention Test, which aims to assess the presence and the extent of visual neglect. This test consists of a random array of verbal and non-verbal stimuli. The stimuli are 52 large stars (14 mm), 13 randomly positioned letters and 19 short (3-4 letters) words are interspersed with 56 smaller stars (8mm) which comprise the target stimuli. The patient is instructed to cancel all the small stars.

~5-6 weeks from baseline
Mean change from baseline score on Letter Cancellation Test after 10 therapy sessions
Ramy czasowe: ~3 weeks from baseline

The Letter Cancellation test is a sub-test from the Behavioural Inattention Test, which aims to assess the presence and the extent of visual neglect. Paper and pencil test in which patients are required to scan, locate, and cross out designated targets from a background of distractor letters. The test consists of 5 rows of 34 upper case letters presented on a rectangular page. Forty target stimuli are positioned such that each appears in equal number on both sides of the page. Each letter is 6 mm high and positioned 2 mm apart.

~3 weeks from baseline
Mean change from baseline score on Letter Cancellation Test after 20 therapy sessions
Ramy czasowe: ~5-6 weeks from baseline

The Letter Cancellation test is a sub-test from the Behavioural Inattention Test, which aims to assess the presence and the extent of visual neglect. Paper and pencil test in which patients are required to scan, locate, and cross out designated targets from a background of distractor letters. The test consists of 5 rows of 34 upper case letters presented on a rectangular page. Forty target stimuli are positioned such that each appears in equal number on both sides of the page. Each letter is 6 mm high and positioned 2 mm apart.

~5-6 weeks from baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 maja 2023

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2024

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2024

Daty rejestracji na studia

Pierwszy przesłany

16 sierpnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 sierpnia 2022

Pierwszy wysłany (Rzeczywisty)

18 sierpnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 września 2026

Ostatnia weryfikacja

1 listopada 2024

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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 .

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