Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation

Официальное название

Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis

Обзор

The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS). The second aim is to identify the cognitive and motor profiles of MS patients who benefit the most from either the combined cognitive-motor rehabilitation intervention or the isolated cognitive or motor treatments.

Вмешательства

• Устройство Cognitive rehabilitation: CG group
  60 minutes of cognitive training with a computerized device
• Устройство Motor rehabilitation: MG group
  60 minutes of robot-assisted gait training with the G-EO System
• Устройство Combined rehabilitation: CbG group
  30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System. To mitigate the effects of fatigue in sequential training, the patients included in this group will undergo the cognitive (treatment CG) and motor (treatment MG) sessions in a counterbalanced order (half of the participants will follow the CG-MG sequence, and the other half will follow the MG-CG sequence). Five-minute breaks will be provided between the cognitive and mot

Первичные конечные точки

• Symbol Digit Modalities Test [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment]
• 2-minute walking test [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment]

Вторичные конечные точки (12)

• Brief Repeatable Battery (BRB) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• The Stroop Test (ST) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• Trail Making Test (TMT) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• The Verbal Fluency Test (VF) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• The Modified Five Point Test (MFPT) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• Test of Attentional Performance (TAP; version 2.3.1) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• N-Back task [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• Time up and Go (TUG) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• eight-infrared camera system (sampling frequency: 60-120 fps) with the VICON Vero 2.2 motion analysis system (Vicon Motion Analysis System Ltd), [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• Modified Fatigue Impact Scale (MFIS) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• The Multiple Sclerosis Quality of Life-29 (MSQOL-29) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
• Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: At the end of the treatment]

Критерии участия

Критерии включения

• presence of mild (one or two neuropsychological tests below the cut-off score, 5th percentile) or severe (more than two neuropsychological tests below the cut-off score, 5th percentile) cognitive impairment,
• mild to moderate walking disability with Expanded Disability Status Scale (EDSS) between 3 and 6,
• no relapse or associated steroid use in the past three months,
• adequate visual and auditory capacity to operate computer software.

Критерии исключения

• presence of other neurological disorders than MS,
• major psychiatric disorders,
• high levels of anxiety and/or depression (score>20 for Depression scale and up to 14 for Anxiety scale on Italian adaptation of the Depression, Anxiety and Stress Scale (DASS-21),
• substance abuse,
• any type of rehabilitation intervention in the month prior to recruitment
• pharmacological therapy not well defined and/or changed during the study
• presence of paroxysmal vertigo
• lower limb botulinum toxin injections within the previous 12 weeks

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

Италия · 1 центр

• Sezione medicina fisica e riabilitativa dipartimento di neuroscienze — Verona

Идентификаторы

NCT: NCT06820125 · 4257CESC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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