Rehabilitation Program to Improve Balance in Patients With Parkinson's Disease: Dual-Task Exercise - A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if a rehabilitative pathway based on dual-task exercise improves balance in patients with Parkinson's disease, compared to a traditional rehabilitation program. It will also investigate the reduction of fall risk, and improvement in autonomy and quality of life. The main questions it aims to answer are: * Does dual-task exercise improve balance more effectively than traditional rehabilitation in Parkinson's patients? * Does dual-task exercise reduce the risk of falls? * Does dual-task exercise improve patient autonomy in daily activities? * Does dual-task exercise enhance the overall quality of life for Parkinson's patients? Researchers will compare a dual-task exercise program to a standard rehabilitation program. Both groups will receive 20 sessions, 2-3 times a week for two months, each lasting 45 minutes. The study will be double-blinded, meaning neither participants nor researchers involved in treatment administration and data collection will know group assignments. Randomization will be done using dedicated software to ensure unbiased group distribution. Participants will: * Have a confirmed diagnosis of Parkinson's disease (Movement Disorder Society criteria). * Be in an early to moderate stage of the disease (Hoehn and Yahr score \< 3). * Be over 30 years old. * Be able to provide informed consent. * Have a stable medication regimen for at least three months. Exclusions include: * Hoehn and Yahr score ≥3. * Severe cognitive or psychiatric disorders (e.g., dementia). * Use of interfering medications or treatments. * Participation in other clinical trials. * Pregnancy or breastfeeding. * Need for medication changes during rehabilitation. Evaluations will be conducted at baseline (T=0), after rehabilitation (T=1), and at a two-month follow-up (T=2). Assessments will include the Tinetti Balance and Gait scales, Timed Up and Go (TUG) test, VAS pain scale, TAMPA Scale for Kinesiophobia, Global Perceived Effect (GPE), Barthel Index, EuroQoL-5D-5L, and ABC Scale. UPDRS, Hoehn and Yahr scale, and MOCA Scale will be administered only at baseline (T=0).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• Confirmed diagnosis of Parkinson's Disease (Movement Disorder Society criteria).

• Early to moderate stage of the disease (Hoehn and Yahr score \< 3).

• Age over 30 years.

• Ability to provide informed consent.

• Stable pharmacological therapy for at least 3 months.

Locations
Other Locations
Italy
Fondazione Paolo Sesto - Centro Adriatico
RECRUITING
Pescara
Contact Information
Primary
Teresa Paolucci
teresa.paolucci@unich.it
+39 3479338625
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 74
Treatments
Experimental: Dual-Task Exercise Program
This arm consists of participants assigned to receive a structured rehabilitative pathway based on dual-task exercises. This program integrates motor and cognitive tasks simultaneously, and is designed to improve balance, reduce fall risk, and enhance autonomy and quality of life in Parkinson's patients. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes.
Active_comparator: Standard Rehabilitation Program
This arm consists of participants assigned to receive a standard rehabilitation program. This intervention focuses on traditional motor rehabilitation techniques and serves as the active control group for comparison with the dual-task intervention. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes.
Sponsors
Leads: G. d'Annunzio University

This content was sourced from clinicaltrials.gov