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

Prof. Massimo Filippi

Status: Not yet enrolling

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05799690

GR-2021-12374005

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for PD patients:

• 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

Inclusion criteria for healthy controls:

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 5 patient groups

DUAL-TASK+AOT-MI

Experimental group

Description:

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

Treatment:

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

DUAL-TASK

Active Comparator group

Description:

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

Treatment:

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

DUAL-TASK+AOT-MI_DOUBLE

Experimental group

Description:

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

Treatment:

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

DUAL-TASK_DOUBLE

Active Comparator group

Description:

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

Treatment:

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

Healthy subjects

No Intervention group

Description:

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