About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Concomitant major neurological or psychiatric disorders
Severe cardio-pulmonary, renal, or hepatic diseases
Changes in baseline pharmacological therapy within 3 months prior to enrollment
Trial design
Single group
Treatments tested in this trial
Combined group motor training and individual digital cognitive stimulation
BehavioralParticipants 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)
Treatment groups
Trial outcomes
Primary outcomes
Feasibility Outcomes: Eligibility Rate
Calculated as the ratio of eligible patients to the total number of screened patients.
Feasibility Outcomes: Recruitment Rate
Calculated as the ratio of recruited patients to total eligible patients.
Feasibility Outcomes: Monthly Recruitment Rate
Defined as the average number of participants enrolled per month.
Feasibility Outcomes: Drop-out Rate
The percentage of participants who withdraw from the study.
Secondary outcomes
Motor Outcomes: Change in dynamic balance, mobility, and gait
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.
Motor Outcomes: Change in Gait speed
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.
Motor Outcomes: Change in Distance Walked
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.
Motor Outcomes: Change in Dynamic Balance
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.
Sponsors and contacts
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