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

22 marzo 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

88

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • University of Alabama at Birmingham

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altri nomi:
  • InSight (registered trademark of Posit Science, Inc.)
Comparatore attivo: 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.
Altri nomi:
  • InSight (registered trademark of Posit Science, Inc.)
Altro: 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.
Altri nomi:
  • InSight (registered trademark of Posit Science, Inc.)
Altro: 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.
Altri nomi:
  • InSight (registered trademark of Posit Science, Inc.)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to contact
Lasso di tempo: 3 months
Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls
3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Useful Field of View (UFOV)
Lasso di tempo: 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)
Lasso di tempo: 3 months
Difference in MoCA, Trails, and Stroop between baseline and immediate post-training assessments in PD and healthy controls
3 months
Vigilance
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Amy Amara, MD, PhD, University of Alabama at Birmingham

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2015

Completamento primario (Effettivo)

1 febbraio 2018

Completamento dello studio (Effettivo)

1 febbraio 2018

Date di iscrizione allo studio

Primo inviato

7 ottobre 2016

Primo inviato che soddisfa i criteri di controllo qualità

7 ottobre 2016

Primo Inserito (Stima)

11 ottobre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 marzo 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 marzo 2018

Ultimo verificato

1 marzo 2018

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • X150203003
  • 5P30AG022838 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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