Effect of Hand Rehabilitation on Cognitive Function in Patients With PD

Официальное название

Effect of Sensory-motor Rehabilitation of the Hand on Cognitive Functions in Patients With Parkinson's Disease

Обзор

Evidence suggests the association between fine motor skills of the hand and cognitive function, as well as the positive effects of hand rehabilitation on hand function and the effectiveness of cognitive rehabilitation on cognitive functions in patients with Parkinson's disease (PD). In response to the question of whether there is a cause-and-effect relationship between fine manual skills and cognitive function, we designed the present randomized controlled trial to investigate the effectiveness of sensory-motor rehabilitation of the hand on cognitive functions compared to the effectiveness of cognitive rehabilitation on sensory-motor skills of the hand in patients with PD. In this double-blinded, randomized controlled trial, a convenience sample including 48 people with PD will participate based on simple non-random sampling. The participants will be allocated randomly through stratified randomization to parallel groups of intervention (sensorimotor hand rehabilitation) and control (cognitive rehabilitation) with a 1:1 allocation ratio. The associate researcher responsible for assessing outcome measures and the statistician responsible for analyzing the data are blinded to the intervention protocol. The intervention protocol for the intervention group includes hand sensory-motor rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week, in addition to cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. The intervention protocol for the control group includes cognitive rehabilitation for 10 one-and-a-half-hour sessions, 3 sessions per week. All participants undergo three assessment sessions: the day before the intervention, the day after the intervention, and one month after the last intervention session. Data will be analyzed using SPSS version 22.0. The significance level will be set at 0.05.

Вмешательства

• Другое Hand Sensorimotor Rehabilitation
  10 one-and-a-half-hour sessions, 3 sessions per week
• Другое Cognitive Remediation
  10 one-and-a-half-hour sessions, 3 sessions per week

Первичные конечные точки

• Montreal Cognitive Assessment [Срок оценки: - The day before the intervention - The day after the intervention - One month after the last intervention session]
• Cambridge Neuropsychological Test Automated Battery - Reaction Time [Срок оценки: - The day before the intervention - The day after the intervention - One month after the last intervention session]
• Cambridge Neuropsychological Test Automated Battery - Spatial Span Test [Срок оценки: - The day before the intervention - The day after the intervention - One month after ending intervention]
• Cambridge Neuropsychological Test Automated Battery - Match to Sample Visual Search Test [Срок оценки: - The day before the intervention - The day after the intervention - One month after the last intervention session]
• Cambridge Neuropsychological Test Automated Battery - Stop Signal Task [Срок оценки: - The day before the intervention - The day after the intervention - One month after the last intervention session]
• KING'S PD Pain Scale [Срок оценки: - The day before staring intervention - The day after ending intervention - one month after ending intervention]
• Box & Block Test [Срок оценки: - The day before starting intervention - The day after ending intervention - One month after ending intervention]
• The Purdue Pegboard Test [Срок оценки: - The day before starting intervention - The day after ending intervention - One month after ending intervention]
• Hand Dynamometer Hydraulic Jamar [Срок оценки: - The day before starting intervention - The day after ending intervention - One month after ending intervention]
• Pinch gauge [Срок оценки: - The day before starting intervention - The day after ending intervention - One month after ending intervention]

Критерии участия

Критерии включения

• A diagnosis of PD by a neurologist based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease;
• 45-65 years old: age of peak incidence of PD;
• Minimum 2 years and maximum 10 years from initial diagnosis: stabilization of the disease process and medications;
• disability level of at most 3 in the Modified Hoehn and Yahr Scale: physically independent;
• Mild cognitive impairment: score between 20 and 26 in Montreal cognitive assessment;
• Signing the written informed consent.

Критерии исключения

• Patients with neurological diseases other than PD
• Patients with orthopedic and internal diseases that would make participation in the study difficult

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07702929 · 2404210

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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