Rehabilitation With Dual-task Exercises to Improve Balance in Patients With Parkinson's Disease

NCT ID: NCT07013214

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2026-02-28

Brief 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).

Conditions

Parkinson Disease (PD), Postural Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dual-Task Exercise

Intervention Type: BEHAVIORAL

This intervention consists of exercises that integrate motor tasks (e.g., balance training, walking) with concurrent cognitive tasks (e.g., counting, verbal fluency, decision-making tasks). The progression of exercises will be tailored to the individual's abilities, gradually increasing the difficulty of both the motor and cognitive components.

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.

Group Type: ACTIVE_COMPARATOR

Standard Rehabilitation

Intervention Type: BEHAVIORAL

This intervention consists of conventional exercises aimed at improving balance, gait, posture, and flexibility, without the integration of simultaneous cognitive tasks. The program will focus on established physical therapy techniques for Parkinson's disease.

Interventions

Dual-Task Exercise

This intervention consists of exercises that integrate motor tasks (e.g., balance training, walking) with concurrent cognitive tasks (e.g., counting, verbal fluency, decision-making tasks). The progression of exercises will be tailored to the individual's abilities, gradually increasing the difficulty of both the motor and cognitive components.

Intervention Type: BEHAVIORAL

Standard Rehabilitation

This intervention consists of conventional exercises aimed at improving balance, gait, posture, and flexibility, without the integration of simultaneous cognitive tasks. The program will focus on established physical therapy techniques for Parkinson's disease.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Hoehn and Yahr score ≥ 3.
• Severe cognitive or psychiatric disorders (e.g., dementia).
• Use of interfering medications or treatments.
• Participation in another clinical trial.
• Pregnancy or breastfeeding.
• Need for changes in pharmacological therapy during the rehabilitation period.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

Professor, MD, PhD, Physical Medicine and Rehabilitation Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Paolo Sesto - Centro Adriatico

Pescara, PE, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Teresa Paolucci

Role: CONTACT

teresa.paolucci@unich.it

+39 3479338625

Facility Contacts

Teresa Paolucci

Role: primary

teresa.paolucci@unich.it

+39 3479338625

Other Identifiers

237

Identifier Type: OTHER

Identifier Source: secondary_id

180426/25

Identifier Type: -

Identifier Source: org_study_id