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

NCT07013214 | Completed DMC

• 2 other identifiers: 180426/25237
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• UPDRS (Unified Parkinson's Disease Rating Scale)

  It is a widely used scale to assess the severity of symptoms in patients with Parkinson's disease. It consists of four sections: non-motor and mental aspects, motor aspects, motor complications, and treatment. It evaluates aspects such as tremor, rigidity, bradykinesia, balance, and daily activities.

  Baseline

• Hoehn and Yahr scale

  It is a staging scale that classifies the severity of Parkinson's disease into five stages, from mild (stage 1) to severe (stage 5), based on the presence of motor symptoms and functional impairment.

  Baseline

• MOCA Scale (Montreal Cognitive Assessment)

  The MoCA is a screening tool used to assess cognitive functions. It is designed to detect mild and moderate cognitive impairments, such as those associated with dementia or other neurological conditions. The scale covers various cognitive domains, including attention, concentration, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The maximum score is 30 points, and a score below 26 may indicate the presence of cognitive impairment.

  Baseline

• Tinetti Balance and Gait scales

  Two distinct but related scales: * Tinetti Balance Scale: assesses fall risk through various balance tests. * Tinetti Gait Scale: evaluates gait and the related risk of falling. Both scales are used to identify individuals at risk of falling and to monitor the effectiveness of interventions.

  -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

• TUG (Timed Up and Go test)

  It is a simple test that measures the time a person takes to stand up from a chair, walk three meters, turn around, return, and sit down. It is used to assess balance and fall risk.

  -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

Secondary Outcomes (6)

• Visual Analogue Scale for pain (VAS)

  -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

• TAMPA Scale (Tampa Scale for Kinesiophobia)

  -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

• Global Perceived Effect (GPE)

  -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

• Barthel Index

  -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

• EuroQoL-5D-5L (EuroQoLD5L)

  -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion

Study Arms (2)

Dual-Task Exercise Program

EXPERIMENTAL

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.

Behavioral: Dual-Task Exercise

Standard Rehabilitation Program

ACTIVE COMPARATOR

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.

Behavioral: Standard Rehabilitation

Interventions

Dual-Task Exercise 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.

Dual-Task Exercise Program

Standard Rehabilitation 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.

Standard Rehabilitation Program

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Fondazione Paolo Sesto - Centro Adriatico

Pescara, PE, 65126, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, Physical Medicine and Rehabilitation Physician

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 7, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)