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

NCT06957405 | Recruiting

• 1 other identifier: PM-DP NeuroMat
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Freezing of Gait

Keywords

Parkinson disease; Freezing of Gait; Mental Practice; Telerehabilitation; Dynamic Neuro-Cognitive Imagery; Motor Imagery; Gait Disorders

Outcome Measures

Primary Outcomes (1)

• Rapid Turns Test

  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.

  Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).

Secondary Outcomes (4)

• 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).

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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.

Behavioral: MPPG (Mental and Physical Practice Group)

Control Group (CG)

ACTIVE COMPARATOR

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).

Behavioral: PPG (Physical Practice Group)

Interventions

MPPG (Mental and Physical Practice Group) BEHAVIORAL

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.

Also known as: (Mental Practice + Physical Practice)

Experimental Group (EG)

PPG (Physical Practice Group) BEHAVIORAL

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.

Also known as: (Physical Practice + Stretching)

Control Group (CG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-900, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Interventions

serglycin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Elisa P Piemonte, PT, PHD

CONTACT

55 11 30917451; elisapp@usp.br

Paloma R Silva, PT

CONTACT

55 11 976193193; paloma.rsilva@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-blind, randomized controlled trial.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: January 25, 2025
• Primary Completion: August 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-04

Locations

BR (1)