- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Sofia Straudi, MD, PhD
- Telefonszám: +390532238720
- E-mail: sofia.straudi@unife.it
Tanulmányi helyek
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FE
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Ferrara, FE, Olaszország, 44124
- Toborzás
- Ferrara University Hospital
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Kapcsolatba lépni:
- Sofia Straudi, MD, PhD
- Telefonszám: 0532238720
- E-mail: sofia.straudi@unife.it
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Alkutató:
- Gaia Palma, PhD student, Psychologist
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Alkutató:
- Andrea Baroni, Physiotherapist, PhD
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Feasibility Outcomes: Eligibility Rate
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Motor Outcomes: Change in dynamic balance, mobility, and gait
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)
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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
Időkeret: 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.
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 710/2025/Oss/AOUFe
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