Remote Mental Practice for Freezing of Gait in Parkinson's Disease

Официальное название

Effects of a Remote Mental and Physical Practice Intervention on Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Trial

Обзор

This single-blind, randomized controlled trial investigates the effects of a remotely delivered intervention based on mental practice (MP) combined with physical practice (PP) on freezing of gait (FOG) severity in people with idiopathic Parkinson's disease (PD). Fifty participants will be randomly assigned to either the experimental group (MP + PP) or a control group (PP + stretching). The intervention consists of 10 video-supervised sessions over 6 weeks. Primary outcomes include the Rapid Turn Test and percentage of time spent with FOG (%FOG). Secondary outcomes include the New Freezing of Gait Questionnaire (NFOG-Q), Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire-39 (PDQ-39), and Telephone Montreal Cognitive Assessment (T-MoCA). The study aims to demonstrate whether MP using Dynamic Neuro-Cognitive Imagery (DNI) techniques can effectively reduce FOG severity and improve motor and cognitive function in people with PD.

Подробное описание

This trial aims to evaluate a home-based remote intervention delivered via encrypted video calls by physiotherapists trained in both Mental Practice (MP) and Physical Practice (PP) protocols. Participants undergo 10 structured training sessions, each lasting 45-60 minutes, across six weeks. The experimental intervention consists of two blocks of first-person kinesthetic MP and two blocks of corresponding PP. The MP is guided using DNI principles, emphasizing goal-directed control, body schema reinforcement, and environmental context. Each block lasts approximately 10 minutes and focuses on gait-related challenges. Safety measures, including environmental checks and the presence of a caregiver (when applicable), are verified before each session. The control group performs the same physical practice but replaces the MP with guided seated stretching exercises. Assessments are conducted at baseline, post-intervention, and 30-day follow-up, by a blinded evaluator. The Rapid Turn Test is video-recorded and independently analyzed. A repeated measures ANOVA will be used for statistical analysis.

Вмешательства

• Поведенческое MPPG (Mental and Physical Practice Group)
  Participants in this group will undergo 10 remote sessions over 6 weeks, each session lasting 45-60 minutes. Each session consists of: (1) two blocks of first-person kinesthetic MP, conducted while seated with eyes closed and guided using DNI principles; and (2) two blocks of corresponding PP, involving simulated gait components such as ankle mobility, postural weight shifts, and short-distance walking under real-time supervision. Each block lasts approximately 10 minutes. The MP emphasizes atte
• Поведенческое PPG (Physical Practice Group)
  Participants in the control group will receive 10 remote sessions over 6 weeks, each session lasting 45-60 minutes. Each session consists of the same PP as the experimental group but replaces motor imagery with two 10-minute seated stretching block, focusing on the upper limbs and trunk. The PP follows the same structure and duration as in the experimental group. All sessions are delivered remotely via live video by physiotherapists trained in both protocols. Volume, frequency, and interaction l

Первичные конечные точки

• Rapid Turns Test [Срок оценки: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).]

Вторичные конечные точки (4)

• New Freezing of Gait Questionnaire (NFOG-Q) [Срок оценки: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).]
• Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [Срок оценки: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention .]
• Parkinson Disease Questionnaire - 39 (PDQ-39) [Срок оценки: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).]
• Telephone Montreal Cognitive Assessment (T-MoCA) [Срок оценки: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).]

Критерии участия

Критерии включения

• Clinical diagnosis of idiopathic PD;
• Use of dopaminergic medication;
• Experiencing FOG (positive response to the first question of the New Freezing of Gait Questionnaire - NFOG-Q);
• Able to walk independently at home;
• Access to internet and video call device;
• Agree to participate in the study.

Критерии исключения

• Other neurological disorders;
• Severe cardiovascular and/or respiratory alterations;
• Uncorrected visual and/or auditory alterations;
• Cognitive impairment, detectable through the Telephone Montreal Cognitive Assessment (T-MoCA, < 12);
• Inability to perform motor imageryT during the administration of the Kinesthetic and Visual Imagery Questionnaire - 20 (KVIQ-20, < 20)

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

Бразилия · 1 центр

• University of Sao Paulo — São Paulo

Идентификаторы

NCT: NCT06957405 · PM-DP NeuroMat

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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