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

G. d'Annunzio University74 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Dual-Task ExerciseBEHAVIORAL

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 RehabilitationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.