Effects of a Remote Mental and Physical Practice Intervention on Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rapid Turns Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors blinded to group allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Experimental Group (EG)
In the Experimental Group (EG), the intervention will consist of 10 remote sessions, each including two blocks of Mental Practice (MP) and two blocks of corresponding Physical Practice (PP), focuses on gait-related challenges.
干预措施: MPPG (Mental and Physical Practice Group) (Behavioral)
Control Group (CG)
In the Control Group (CG), the intervention will consist of 10 remote sessions, each including two blocks of seated upper-limb stretching exercises followed by two blocks of Physical Practice (PP), with the same structure and duration as in the Experimental Group (EG).
干预措施: PPG (Physical Practice Group) (Behavioral)
结局指标
主要结局
Rapid Turns Test
时间窗: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).
A provocative freezing test. The individuals will be instructed to spin around their own axis repeatedly, in both directions, at high speed. A Percentage of time with FOG (%FOG) will be performed based on video recordings of Rapid Turns Test to measure the actual severity of freezing, calculated using the formula (total duration of FOG during the test \* 100) / total duration of the test.
次要结局
- New Freezing of Gait Questionnaire (NFOG-Q)(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(Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention .)
- Parkinson Disease Questionnaire - 39 (PDQ-39)(Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).)
- Telephone Montreal Cognitive Assessment (T-MoCA)(Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).)