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

NCT07833748 | Recruiting

• 1 other identifier: 710/2025/Oss/AOUFe
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson Disease; Motor-Cognitive Training; Cognitive Rehabilitation; Motor Rehabilitation

Outcome Measures

Primary Outcomes (11)

• Feasibility Outcomes: Eligibility Rate

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

  Baseline

• Feasibility Outcomes: Recruitment Rate

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

  Baseline

• Feasibility Outcomes: Monthly Recruitment Rate

  Defined as the average number of participants enrolled per month.

  Baseline

• Feasibility Outcomes: Drop-out Rate

  The percentage of participants who withdraw from the study.

  score changes after intervention (4 weeks, T1)

• Feasibility Outcomes: Adherence Rate

  The percentage of scheduled training sessions attended

  score changes after intervention (4 weeks, T1)

• Feasibility Outcomes: Longitudinal Retention Rate

  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

  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

  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

  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

  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)

  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 Outcomes (13)

• Motor Outcomes: Change in dynamic balance, mobility, and gait

  Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

• Motor Outcomes: Change in Gait speed

  Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

• Motor Outcomes: Change in Distance Walked

  Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

• Motor Outcomes: Change in Dynamic Balance

  Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

• Motor Outcomes: Change in Finger motor speed

  Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment)

Study Arms (1)

Combined Motor-Cognitive Training Group

EXPERIMENTAL

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

Interventions

Combined group motor training and individual digital cognitive stimulation BEHAVIORAL

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)

Combined Motor-Cognitive Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concomitant major neurological or psychiatric disorders
• Severe cardio-pulmonary, renal, or hepatic diseases
• Changes in baseline pharmacological therapy within 3 months prior to enrollment

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, FE, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Sofia Straudi, MD, PhD

CONTACT

+390532238720; sofia.straudi@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 22, 2026
• Study Start: June 1, 2026
• Primary Completion: August 31, 2026
• Study Completion: September 1, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

IT (1)