Comparison of Different Rehabilitation Protocols in Parkinson's Disease With Postural Instability and Gait Disorders

NCT ID: NCT05799690

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-04-30

Brief Summary

The aim of the study is to compare the effects of 2 different dosages and modalities of motor-cognitive rehabilitation in Parkinson's disease with postural instability and gait disorders (PD-PIGD) on clinical features, neuroimaging and blood-based biomarkers at short-term (2 months) and long-term (7 months) follow-up. Fifty subjects with PD-PIGD will be randomized in 2 training groups: DUAL-TASK+AOT-MI and the DUAL-TASK groups. The DUAL-TASK+AOT-MI group will perform a dual-task gait/balance training consisting of action observation training (AOT) and motor imagery (MI) combined with practicing the observed-imagined exercises; DUAL-TASK group will perform the same exercises combined with watching landscape videos. The training will last 6 weeks, 3 times/week, 1 hour per session.

Before and after training (W6), all the patients will undergo neurological, gait/balance, cognitive/behavioral, magnetic resonance imaging (MRI) and serum biomarkers evaluations. Neurological, gait/balance, cognitive/behavioral assessments and serum biomarkers will be also repeated at the 14-week follow-up (W14) to assess maintenance of results.

Patients of both DUAL-TASK+AOT-MI and DUAL-TASK groups will be further randomized to repeat the training (6 weeks, 3 times/week, 1 hour each session) starting at W14 (DUAL-TASK+AOT-MI_DOUBLE and DUAL-TASK_DOUBLE groups). After six weeks (W20) all the subjects repeating the training will be evaluated (neurological, gait/balance, cognitive/behavioral assessments). At 28-week follow-up (W28), the whole sample of patients will be assessed with neurological, gait/balance, cognitive/behavioral, MRI and serum biomarkers evaluations. All MRI scans will be acquired at least 12 hours after last dopaminergic therapy administration to mitigate the pharmacological effects on neural activity. Twenty age- and sex-matched healthy controls will be recruited to perform gait/balance and cognitive/behavioral assessments, blood sample and brain MRI acquisition at baseline. The secondary aims of the study are to define the neuroimaging and blood-based biomarkers of PD-PIGD patients presenting different clinical features (e.g. presence of mild cognitive impairment, freezing of gait, falls and mood disturbances) and to evaluate the role of blood-based and neuroimaging biomarkers, together with clinical characteristics, in predicting the response to different dosages of rehabilitation in PD-PIGD throughout the development of a machine-learning algorithm.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

DUAL-TASK+AOT-MI

Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) for six weeks.

Group Type: EXPERIMENTAL

Gait and balance training with dual-task + action observation and motor imagery (six weeks)

Intervention Type: BEHAVIORAL

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI.

1 hour, 3 times a week for six weeks.

DUAL-TASK

Dual-task gait and balance training with vision of landscape videos for six weeks.

Group Type: ACTIVE_COMPARATOR

Gait and balance training with dual-task (six weeks)

Intervention Type: BEHAVIORAL

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution.

1 hour, 3 times a week for six weeks.

DUAL-TASK+AOT-MI_DOUBLE

Dual-task gait and balance training with cognitive facilitations (action observation and motor imagery) repeated two times (twelve weeks: 6 + 6).

Group Type: EXPERIMENTAL

Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6)

Intervention Type: BEHAVIORAL

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI.

The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14)

1 hour, 3 times a week for twelve weeks (6+6).

DUAL-TASK_DOUBLE

Dual-task gait and balance training with vision of landscape videos repeated two times (twelve weeks: 6 + 6).

Group Type: ACTIVE_COMPARATOR

Gait and balance training with dual-task (twelve weeks: 6 +6)

Intervention Type: BEHAVIORAL

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution.

The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14)

1 hour, 3 times a week for twelve weeks (6+6).

Healthy subjects

Age- and sex-matched healthy subjects recruited to compare gait, neuropsychological, serum and functional magnetic resonance imaging characteristics at baseline.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gait and balance training with dual-task + action observation and motor imagery (six weeks)

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI.

1 hour, 3 times a week for six weeks.

Intervention Type: BEHAVIORAL

Gait and balance training with dual-task (six weeks)

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution.

1 hour, 3 times a week for six weeks.

Intervention Type: BEHAVIORAL

Gait and balance training with dual-task + action observation and motor imagery (twelve weeks: 6 + 6)

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing a balance or gait task (action observation - AOT) and will imagine the same exercise (motor-imagery - MI) before task execution. Each training session will be proposed with the following modality: 2 minutes of AOT - 5 minutes of task execution - 2 minutes of MI - 5 minutes of task execution. Patients will be explicitly asked to concentrate on how the actions are performed in the videos and to carefully use MI to improve their motor performance. Patients will not be allowed to perform any movement while watching videos or during MI.

The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14)

1 hour, 3 times a week for twelve weeks (6+6).

Intervention Type: BEHAVIORAL

Gait and balance training with dual-task (twelve weeks: 6 +6)

Increasingly difficult gait and balance exercises up to include dual-task. During each training session, four exercises (5 minutes of execution, two times each) will be proposed. Patients will observe a 2-minute video clip showing static landscapes before task execution. Each training session will be proposed with the following modality: 2 minutes of videos - 5 minutes of task execution - 2 minutes of videos - 5 minutes of task execution.

The training protocol will be repeated two times: once starting at baseline, once starting after the first follow-up at week 14 (W14)

1 hour, 3 times a week for twelve weeks (6+6).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 45 years ≤ age ≤ 85 years;
• Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
• Hoehn & Yahr (H&Y) score <= 4
• PIGD phenotype
• Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
• No dementia according to Litvan's criteria and Mini-Mental Status Examination score (MMSE) >= 24
• No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition
• Oral and written informed consent to study participation

• sex-matched and age-matched (age range: mean age of PD years ± 15 years);
• oral and written informed consent to study participation

Exclusion Criteria

• Medical conditions or substance abuse that could interfere with cognition;
• Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability;
• Contraindications to undergoing MRI examination;
• Brain damage at routine MRI, including lacunae and extensive cerebrovascular disorders;
• Denied oral and written informed consent to study participation.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: collaborator

Prof. Massimo Filippi

OTHER

Sponsor Role: lead

Responsible Party

Prof. Massimo Filippi

Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS San Raffaele

Milan, , Italy

Site Status: RECRUITING

Neurology Unit, Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Elisabetta Sarasso, MSc, PT

Role: CONTACT

sarasso.elisabetta@hsr.it

0226434685 ext. 0039

Roberta Balestrino, MD

Role: CONTACT

balestrino.roberta@hstr.it

0226436168 ext. 0039

Facility Contacts

Massimo Filippi, Prof, MD

Role: primary

filippi.massimo@hsr.it

0226433054 ext. 0039

Michele Tinazzi, Prof, MD

Role: primary

Other Identifiers

GR-2021-12374005

Identifier Type: -

Identifier Source: org_study_id