COMPuter-assisted Self-training to Improve EXecutive Function

Официальное название

Computer-Assisted Self-Training to Improve Executive Function Versus Unspecific Training in Patients After Stroke, Cardiac Arrest or in Parkinson's Disease: a Randomized Controlled Trial

Обзор

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to generally cognitively stimulating activities on a computer

Подробное описание

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to completing generally cognitively stimulating activities on a computer. A total of 307 patients is expected to be enrolled. All patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures at baseline, after the intervention and at follow-up. All patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation.

Вмешательства

• Поведенческое Computer-based cognitive rehabilitation (CBCR)
  CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
• Поведенческое General computer-based cognitive stimulation
  For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.

Первичные конечные точки

• CABPad Working Memory Test [Срок оценки: After the end of the intervention (8 weeks after baseline)]

Вторичные конечные точки (12)

• CABPad Working Memory Test - 3 months follow-up [Срок оценки: At follow-up visit 3 months after end of intervention]
• Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL) [Срок оценки: At follow-up visit 3 months after the end of the intervention]
• Trail Making A [Срок оценки: Directly after the intervention, eight weeks after inclusion]
• Trail Making A [Срок оценки: At follow-up visit 3 months after the end of the intervention]
• Trail Making B [Срок оценки: Directly after the intervention, eight weeks after inclusion]
• Trail Making B [Срок оценки: At follow-up visit 3 months after the end of the intervention]
• SDMT [Срок оценки: Directly after the intervention, eight weeks after inclusion]
• SDMT [Срок оценки: At follow-up visit 3 months after the end of the intervention]
• Phonological verbal fluency test [Срок оценки: Directly after the intervention, eight weeks after inclusion]
• Phonological verbal fluency test [Срок оценки: At follow-up visit 3 months after the end of the intervention]
• Categorical verbal fluency test [Срок оценки: Directly after the intervention, eight weeks after inclusion]
• Categorical verbal fluency test [Срок оценки: At follow-up visit 3 months after the end of the intervention]

Критерии участия

Критерии включения

• A diagnose of stroke, cardiac arrest or Parkinson's disease.
• Aged 18 years or older.
• Impaired working memory measured with CABPad working memory test, cut off for inclusion: 5 symbols or less backwards
• Computer and internet access at home.
• Providing informed consent.

Inclusion criteria specific for stroke

• Inclusion within 6 months post-stroke
• Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.
• Initial stroke severity >/= NIHSS 3.

Inclusion criteria specific for cardiac arrest

• Inclusion within 6 months post ictus.

Inclusion criteria specific for Parkinson's disease

• Clinical diagnosis of PD.
• Anti-parkinsonian medical treatment (dopaminergic or other).

Критерии исключения

• Informed consent not provided
• Other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator
• Not able to participate according to investigator

Exclusion criteria specific for stroke

• Patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (Patient sustains total denial of executive symptoms over time)
• Patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction.

Exclusion criteria specific for cardiac arrest • None

Exclusion criteria specific for PD

• Diagnosis of PD Dementia according to the MDS PD Dementia criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

• Bispebjerg Hospital — Copenhagen
• Rigshospitalet — Copenhagen

Публикации

• Svaerke K, Christensen L, Lokkegaard A, Kjaergaard J, Jacobsen JC, Engelter S, Modrau B, Quinn T, Traenka C, Sunnerhagen KS, Christensen H. The COMPEX-trial: computer-based cognitive rehabilitation to improve executive function versus unspecific training in patients after stroke, cardiac arrest or in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2026 Mar 19;27(1):3 PMID 41857604

Идентификаторы

NCT: NCT04229056 · H-19039236

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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