Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06957405
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Mental Practice for Freezing of Gait in Parkinson's Disease
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: