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Integrated Motor-Cognitive Training in Parkinson's Disease: A Feasibility Study (P_Feasibility)

2026. szeptember 16. frissítette: University Hospital of Ferrara

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

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

12

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

    • FE
      • Ferrara, FE, Olaszország, 44124
        • Toborzás
        • Ferrara University Hospital
        • Kapcsolatba lépni:
        • Alkutató:
          • Gaia Palma, PhD student, Psychologist
        • Alkutató:
          • Andrea Baroni, Physiotherapist, PhD

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

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

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

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
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.

  • Cognitive Session (30 min): Training delivered individually and tailored to baseline, individual-specific deficits using the NeuronUP application. Each session includes 5 gamified exercise types (4 minutes each) with adaptive difficulty and optional 2-minute breaks.
  • Motor Session (1 h): Group circuit of 6 stations (7 minutes for station, 2-min breaks): Stations 1-2: Cardiovascular (stepping, sit-to-stand); 3: Dynamic balance with external constraints (stepping over obstacles); 4: Dynamic balance with internal constraints (walking around obstacles); 5: Static balance exercises; 6: Functional movement transfers (Floor-to-standing)

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Feasibility Outcomes: Eligibility Rate
Időkeret: Baseline

Calculated as the ratio of eligible patients to the total number of screened patients.

Baseline
Feasibility Outcomes: Recruitment Rate
Időkeret: Baseline

Calculated as the ratio of recruited patients to total eligible patients.

Baseline
Feasibility Outcomes: Monthly Recruitment Rate
Időkeret: Baseline

Defined as the average number of participants enrolled per month.

Baseline
Feasibility Outcomes: Drop-out Rate
Időkeret: score changes after intervention (4 weeks, T1)

The percentage of participants who withdraw from the study.

score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Adherence Rate
Időkeret: score changes after intervention (4 weeks, T1)

The percentage of scheduled training sessions attended

score changes after intervention (4 weeks, T1)
Feasibility Outcomes: Longitudinal Retention Rate
Időkeret: Post-intervention follow-up assessment (3 months after intervention completion)

The percentage of enrolled participants who complete all follow-up assessments

Post-intervention follow-up assessment (3 months after intervention completion)
Feasibility Outcomes: Self-Reported Acceptability
Időkeret: score changes after intervention (4 weeks, T1)

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)
Feasibility Outcomes: Adverse Events
Időkeret: score changes after intervention (4 weeks, T1)

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)
Feasibility Outcomes: Motor Exercise Intensity
Időkeret: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)

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)
Feasibility Outcomes: Motor Exercise Exertion
Időkeret: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)

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)
Feasibility Outcomes: Digital Cognitive Progression Index (NeuronUP Activity Score)
Időkeret: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)

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)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
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)

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)
Motor Outcomes: Change in Gait speed
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

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)
Motor Outcomes: Change in Distance Walked
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

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)
Motor Outcomes: Change in Dynamic Balance
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

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)
Motor Outcomes: Change in Finger motor speed
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

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)
Cognitive Outcomes: Change in Global cognitive function
Időkeret: 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)
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)

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)
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)

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)
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)

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)
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)

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)
Cognitive Outcomes: Change in perceptive-motor speed
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

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)
Change in Quality of Life
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

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)
Change in Fatigue
Időkeret: Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. június 1.

Elsődleges befejezés (Tényleges)

2026. augusztus 31.

A tanulmány befejezése (Becsült)

2026. szeptember 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. szeptember 10.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 16.

Első közzététel (Tényleges)

2026. szeptember 22.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 22.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 16.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

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