Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06957405

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMPPG (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 attentional focus, sensory detail, and task-specific goals. Sessions are conducted synchronously via video call by trained physiotherapists.
BEHAVIORALPPG (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 levels are matched between groups to ensure equivalence.

Timeline

Start date
2025-01-25
Primary completion
2025-08-01
Completion
2028-01-01
First posted
2025-05-04
Last updated
2025-08-27

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT06957405. Inclusion in this directory is not an endorsement.