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Speed of Processing Training in Patients With Parkinson's Disease and Healthy Older Adults

22 marca 2018 zaktualizowane przez: Amy Amara, MD, University of Alabama at Birmingham

The Effect of Speed of Processing Training on Pedestrian Behavior in Patients With Parkinson's Disease and Healthy Older Adults

The purpose of this prospective, within-subject randomized cross-over design study is to determine if a computer training program (Speed of Processing Training - SOPT) improves safe pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a virtual reality pedestrian environment. Pedestrian injury poses significant risk to healthy older adults and patients with Parkinson's disease. Several age-related changes, including slowing of visual processing speed, increase risky pedestrian behavior. This study will determine if SOPT improves pedestrian behavior in patients with Parkinson's disease and healthy older adults and evaluate the persistence of the SOPT training effects.

Przegląd badań

Status

Zakończony

Szczegółowy opis

Pedestrian injury poses significant risk to healthy older adults and patients with Parkinson's disease. Several age-related changes, including slowing of visual processing speed, increase risky pedestrian behavior. Persons with Parkinson's disease (PD) are at even higher risk of pedestrian injury due to motor and non-motor symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms including slowness, tremor, stiffness, and balance problems. Visual processing speed abnormalities, anxiety, and cognitive problems are common non-motor symptoms.

The Useful Field of View (UFOV®) test is a measure of visual processing speed. The UFOV® test is performed on a touch-screen computer that displays objects in the central and peripheral visual fields for brief durations. Successful performance on the test requires integration of visual sensory information and higher-order cognitive processing. Our own research has shown that the UFOV® test performance correlates with pedestrian behavior in PD patients.

Speed of Processing Training (SOPT) is a computer-based training that uses visual exercises to improve cognitive processing. The training involves identifying and localizing visual information quickly in increasingly demanding visual displays. SOPT has been demonstrated to improve performance on the UFOV test in healthy older adults and PD patients. It is hypothesized that SOPT training will improve pedestrian safety in healthy older adults and PD patients.

In the proposed study, we will use a within-subject, randomized, controlled, cross-over design to evaluate if a computer training program (Speed of Processing Training - SOPT) improves safe pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a virtual reality pedestrian environment and if the effects of training persist long-term.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

88

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Lokalizacje studiów

    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35233
        • University of Alabama at Birmingham

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

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria Parkinson's disease Subjects:

  • Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
  • On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
  • Age ≥50 at the time of entry into the study
  • Age of onset of Parkinson's disease 45 - 85 years old
  • Asymmetric onset of PD
  • Progressive motor symptoms of PD
  • Hoehn and Yahr stages 1-4
  • Ability to walk up and down a single stair step
  • Access to a computer with internet

Exclusion Criteria Parkinson's disease Subjects:

  • Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
  • Neuroleptic treatment at time of onset of Parkinsonism
  • Active treatment with a neuroleptic at time of study entry
  • History of multiple strokes with stepwise progression of Parkinsonism
  • History of multiple head injuries
  • Inability to walk without assistance, including a cane, wheelchair, or walker
  • Cognitive dysfunction that would prevent subject's ability to perform virtual reality simulation, speed of processing training, or complete questionnaire
  • Blindness
  • Any medical condition that, based on discretion of the PI, would prevent the subject's ability to participate in the study

Inclusion Criteria Control Subjects:

  • Age ≥50 at the time of entry into the study
  • On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
  • Ability to walk up and down a single stair step
  • Access to a computer with internet

Exclusion criteria Control Subjects:

  • Parkinson's disease or other neurodegenerative disorder
  • Inability to walk without assistance, including a cane, wheelchair, or walker
  • Cognitive dysfunction that would prevent subject's ability to perform virtual reality simulation, speed of processing training, or complete questionnaires
  • Blindness
  • Any medical condition that, based on the discretion of the PI, would prevent the subject's ability to participate in the study

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: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Control Initial Training Group
Healthy Controls will receive initial SOPT training and will be compared against controls in the delayed training group and the PD subjects in the initial training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
Inne nazwy:
  • InSight (registered trademark of Posit Science, Inc.)
Aktywny komparator: Control Delayed Training Group
Healthy Controls will receive delayed SOPT training and will be compared against controls in the initial training group and the PD subjects in the delayed training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
Inne nazwy:
  • InSight (registered trademark of Posit Science, Inc.)
Inny: PD Initial Training Group
PD subjects will received initial SOPT training and will be compared against PD subjects in the delayed training group and the control subjects in the initial training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
Inne nazwy:
  • InSight (registered trademark of Posit Science, Inc.)
Inny: PD Delayed Training Group
PD subjects will receive delayed SOPT training and will be compared against PD subjects in the initial training group and the control subjects in the delayed training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
Inne nazwy:
  • InSight (registered trademark of Posit Science, Inc.)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to contact
Ramy czasowe: 3 months
Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls
3 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Useful Field of View (UFOV)
Ramy czasowe: 3 months
Difference in UFOV total score between baseline and immediate post-training assessments in PD and healthy controls
3 months
Executive function (MoCA, Trails, Stroop)
Ramy czasowe: 3 months
Difference in MoCA, Trails, and Stroop between baseline and immediate post-training assessments in PD and healthy controls
3 months
Vigilance
Ramy czasowe: 3 months
Differences in vigilance as measured by psychomotor vigilance task between baseline and immediate post-training assessments in PD and healthy controls
3 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Amy Amara, MD, PhD, University of Alabama at Birmingham

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

1 lutego 2015

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2018

Ukończenie studiów (Rzeczywisty)

1 lutego 2018

Daty rejestracji na studia

Pierwszy przesłany

7 października 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 października 2016

Pierwszy wysłany (Oszacować)

11 października 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 marca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 marca 2018

Ostatnia weryfikacja

1 marca 2018

Więcej informacji

Terminy związane z tym badaniem

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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