Remote Mental Practice for Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Freezing of Gait; Parkinson Disease

Treatments: Behavioral: Control Intervention; Behavioral: Experimental intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06957405

PM-DP NeuroMat

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

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.

Treatment:

Behavioral: Experimental intervention

Control Group (CG)

Active Comparator group

Description:

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).

Treatment:

Behavioral: Control Intervention