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- Essai clinique NCT07833748
Integrated Motor-Cognitive Training in Parkinson's Disease: A Feasibility Study (P_Feasibility)
Parkinson's disease is a progressive neurodegenerative condition characterized by both motor symptoms (such as bradykinesia, rigidity, tremor, and postural instability) and non-motor symptoms, including cognitive impairments (affecting working memory, executive functions, and attention). Combined interventions that target both domains simultaneously or consecutively have shown potential to produce superior benefits compared to isolated motor or cognitive training.
The purpose of this study is to evaluate the feasibility, adherence, and preliminary clinical results of efficacy of an integrated and combined motor-cognitive rehabilitation training in patients diagnosed with Parkinson's disease.
This feasibility study will enroll 12 participants with Parkinson's disease. All participants will undergo a comprehensive 10-session integrated rehabilitation program combining digital cognitive individual stimulation and group functional motor training. The primary focus is to assess acceptability, safety, and adherence to this combined approach, while secondary outcomes will observe changes in relevant cognitive and motor clinical variables.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sofia Straudi, MD, PhD
- Numéro de téléphone: +390532238720
- E-mail: sofia.straudi@unife.it
Lieux d'étude
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FE
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Ferrara, FE, Italie, 44124
- Recrutement
- Ferrara University Hospital
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Contact:
- Sofia Straudi, MD, PhD
- Numéro de téléphone: 0532238720
- E-mail: sofia.straudi@unife.it
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Sous-enquêteur:
- Gaia Palma, PhD student, Psychologist
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Sous-enquêteur:
- Andrea Baroni, Physiotherapist, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Diagnosis of Parkinson's disease
- Presence of motor symptoms attributable to Parkinson's disease
- Availability to participate in both treatments (cognitive and motor)
- Severity of symptoms compatible with participation in group physical therapy
- Absence of other medical conditions that could interfere with treatment delivery
- Montreal Cognitive Assessment (MoCA) score >= 18
- Consent to participate in group-based motor training
- Absence of falls in the 3 months prior to baseline evaluation
Exclusion Criteria:
- Concomitant major neurological or psychiatric disorders
- Severe cardio-pulmonary, renal, or hepatic diseases
- Changes in baseline pharmacological therapy within 3 months prior to enrollment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Combined Motor-Cognitive Training Group
Participants will receive a 10-session integrated rehabilitation program combining individual digital cognitive stimulation and group functional motor training |
Participants complete a 10-session motor-cognitive training program (3 times per week). Interventions occur on the same day in groups of 3, supervised by a neuropsychologist and physiotherapist.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility Outcomes: Eligibility Rate
Délai: Baseline
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Calculated as the ratio of eligible patients to the total number of screened patients. |
Baseline
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Feasibility Outcomes: Recruitment Rate
Délai: Baseline
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Calculated as the ratio of recruited patients to total eligible patients. |
Baseline
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Feasibility Outcomes: Monthly Recruitment Rate
Délai: Baseline
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Defined as the average number of participants enrolled per month. |
Baseline
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Feasibility Outcomes: Drop-out Rate
Délai: score changes after intervention (4 weeks, T1)
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The percentage of participants who withdraw from the study. |
score changes after intervention (4 weeks, T1)
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Feasibility Outcomes: Adherence Rate
Délai: score changes after intervention (4 weeks, T1)
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The percentage of scheduled training sessions attended |
score changes after intervention (4 weeks, T1)
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Feasibility Outcomes: Longitudinal Retention Rate
Délai: Post-intervention follow-up assessment (3 months after intervention completion)
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The percentage of enrolled participants who complete all follow-up assessments |
Post-intervention follow-up assessment (3 months after intervention completion)
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Feasibility Outcomes: Self-Reported Acceptability
Délai: score changes after intervention (4 weeks, T1)
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Participants will complete a questionnaire at the end of the intervention to evaluate their subjective experience, perceived benefits, and difficulties of the treatment. Items are rated on a 5-point Likert scale ranging from 1 ("low") to 5 ("extremely high"), with higher scores indicating a more positive evaluation or greater perceived benefit/difficulty. |
score changes after intervention (4 weeks, T1)
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Feasibility Outcomes: Adverse Events
Délai: score changes after intervention (4 weeks, T1)
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The incidence and severity of any adverse events (e.g., falls or excessive fatigue) recorded during the study. |
score changes after intervention (4 weeks, T1)
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Feasibility Outcomes: Motor Exercise Intensity
Délai: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
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The Borg Rating of Perceived Exertion (RPE) will be used to monitor and quantify physical and cognitive effort. Total score ranges from 6 to 20. Higher scores indicate greater perceived exertion |
Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
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Feasibility Outcomes: Motor Exercise Exertion
Délai: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
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The Borg Intensity Scale-Exerciser (BIS-E) will be used to quantify exertion. Total score ranges from 0 to 30, higher scores indicate greater perceived balance effort, difficulty, and postural instability during circuit stations. |
Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
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Feasibility Outcomes: Digital Cognitive Progression Index (NeuronUP Activity Score)
Délai: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
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Digital Cognitive Progression Index (NeuronUP Activity Score) will be used to quantifies session-by-session cognitive performance and adaptive difficulty progression across the 10 training sessions. The score is calculated using NeuronUP's standardized algorithm based on accuracy, total completed phases, and maximum difficulty reached, yielding a score from 0 to 100. Higher scores reflect greater task proficiency and successful progression to higher difficulty levels. This metric serves as an exploratory/feasibility measure of intra-intervention cognitive learning. |
Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Motor Outcomes: Change in dynamic balance, mobility, and gait
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
|
The Timed Up and Go Test (TUG Single Task) will be used to assess the change in dynamic balance, mobility, and gait. Evaluated as time (in seconds). Lower time indicates better functional mobility. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Motor Outcomes: Change in Gait speed
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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10-Meter Walk Test (10MWT) will be used to assess change in gait speed over a 10-meter distance. Evaluated as speed in meters per second (m/s). Higher values indicate faster walking speed and improved gait dynamics. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Motor Outcomes: Change in Distance Walked
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The 6-Minute Walk Test (6MWT) will be used to assess change in total distance walked (in meters) within 6 minutes. Evaluated as total distance walked (in meters) within 6 minutes. Higher distance indicates superior physical endurance. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Motor Outcomes: Change in Dynamic Balance
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Mini-BESTest Total Score will be used to assess change dynamic balance abilities across four subscales (anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait).Total score ranges from 0 to 28, with higher scores indicating superior dynamic balance and lower fall risk. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Motor Outcomes: Change in Finger motor speed
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The Finger Tapping Test Performance will be used to assess motor speed. Measures include total number of taps (right and left hand). Higher tap counts indicate better motor control. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Cognitive Outcomes: Change in Global cognitive function
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
|
The Montreal Cognitive Assessment (MoCA) total score will be used to assess global cognitive function. The scale ranges from 0 to 30, with higher scores indicating better global cognitive function (a score of 26 or above is generally considered normal). |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Cognitive Outcomes: Change in Visual search and processing speed
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The Trail Making Test Part A (TMT-A) will be used to assess visual search abilities and processing speed. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Cognitive Outcomes: Change in executive function, cognitive flexibility, and set-shifting.
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The Trail Making Test Part B (TMT-B) Time will be used to assess executive function, cognitive flexibility, and set-shifting. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Cognitive Outcomes: Change in Information processing speed and attention
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The Symbol Digit Modalities Test (SDMT) will be used to assess information processing speed and attention. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Cognitive Outcomes: Decision-making processing speed and cognitive-motor control
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The Choice Reaction Time (CRT) Task will be used to assess decision-making processing speed and cognitive-motor control. Evaluated via number of correct responses, mean reaction time (in milliseconds) for correct responses, and mean reaction time for error responses. Lower reaction times and higher correct rates indicate better performance. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Cognitive Outcomes: Change in perceptive-motor speed
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The Simple Reaction Time (SRT) will be used to assess reaction time speed. Evaluated as mean reaction time (in milliseconds) for correct responses and number of correct responses. Lower reaction times indicate faster processing speed; Higher correct responses indicate better accuracy. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Change in Quality of Life
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The EQ-5D Quality of Life Questionnaire will be used to assess health-related quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Higher scores indicate superior quality of life. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Change in Fatigue
Délai: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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The Parkinson Fatigue Scale (PFS-16) will be used to assess the impact of fatigue specific to Parkinson's disease. Total mean score ranges from 1 to 5. Higher scores indicate greater perceived fatigue. |
Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 710/2025/Oss/AOUFe
Informations sur les médicaments et les dispositifs, documents d'étude
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