Clinical trial NCT06957405: Remote Mental Practice for Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial
Official title: Effects of a Remote Mental and Physical Practice Intervention on Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Keywords: Parkinson disease
Freezing of Gait
Mental Practice
Telerehabilitation
Dynamic Neuro-Cognitive Imagery
Motor Imagery
Gait Disorders
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind, randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rapid Turns Test
timeFrame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).
Secondary outcomes:
measure: New Freezing of Gait Questionnaire (NFOG-Q)
timeFrame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).
measure: Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
timeFrame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention .
measure: Parkinson Disease Questionnaire - 39 (PDQ-39)
timeFrame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).
measure: Telephone Montreal Cognitive Assessment (T-MoCA)
timeFrame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
References: