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| ID | Type | Description | Link |
|---|---|---|---|
| 237 | Other Identifier | Università degli Studi "G. d'Annunzio" Chieti - DSMOB |
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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:
Participants will:
Exclusions include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| -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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for pain (VAS) | It is a subjective scale that allows patients to rate their level of pain on a 10 cm line, where 0 indicates no pain and 10 indicates the worst imaginable pain. | -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Paolo Sesto - Centro Adriatico | Pescara | PE | 65126 | Italy |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
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| -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) | It assesses the fear of movement or reactivation due to pain or risk of injury. It consists of questions that measure the fear of moving and becoming active again. | -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) | It is a subjective scale used to assess a patient's overall perception of improvement or worsening after an intervention or treatment. A 7-point scale is typically used, where the patient indicates whether they feel much improved, improved, unchanged, worsened, or much worsened. It is a simple and quick tool to obtain a global assessment of the perceived effectiveness of the treatment. | -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion |
| Barthel Index | It is a scale used to assess the level of independence in activities of daily living (ADLs). It includes 10 items covering activities such as eating, dressing, personal hygiene, mobility, using the toilet, continence, and walking or moving around. Each activity is scored, contributing to a total maximum score of 100, where a higher score indicates greater independence. | -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) | It is a tool used to assess health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from no problems to extreme problems. In addition, it includes a visual analogue scale (VAS) where the patient rates their overall health on a scale from 0 to 100. It is widely used in clinical research and public health assessments. | -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion |
| ABC Scale (Activities-specific Balance Confidence Scale) | It measures the patient's confidence in their ability to maintain balance during various daily activities. It consists of 16 items, each rated on a scale from 0% (no confidence) to 100% (complete confidence). It is particularly useful for assessing fall risk and the effectiveness of rehabilitation interventions aimed at improving balance and safety in daily activities. | -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |