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

September 16, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • FE
      • Ferrara, FE, Italy, 44124
        • Recruiting
        • Ferrara University Hospital
        • Contact:
        • Sub-Investigator:
          • Gaia Palma, PhD student, Psychologist
        • Sub-Investigator:
          • Andrea Baroni, Physiotherapist, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined Motor-Cognitive Training Group

Participants will receive a 10-session integrated rehabilitation program combining individual digital cognitive stimulation and group functional motor training
Behavioral: Combined group motor training and individual digital cognitive stimulation

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Outcomes: Eligibility Rate
Time Frame: Baseline

Calculated as the ratio of eligible patients to the total number of screened patients.
Baseline
Feasibility Outcomes: Recruitment Rate
Time Frame: Baseline

Calculated as the ratio of recruited patients to total eligible patients.
Baseline
Feasibility Outcomes: Monthly Recruitment Rate
Time Frame: Baseline

Defined as the average number of participants enrolled per month.
Baseline
Feasibility Outcomes: Drop-out Rate
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Outcomes: Change in dynamic balance, mobility, and gait
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Actual)

August 31, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 710/2025/Oss/AOUFe

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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