NCT05799690

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

Active, enrolled NA Last updated 9 March 2026

What this trial tests

NA trial testing Gait and balance training with dual-task + action observation and motor imagery (six weeks) in Parkinson Disease in 80 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 April 2023

Primary endpoint
30 July 2026

28 April 2027

Quick facts

Lead sponsor	Prof. Massimo Filippi
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	80
Start date	30 April 2023
Primary completion	30 July 2026
Estimated completion	28 April 2027
Sites	2 locations across Italy

Drugs / interventions tested

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

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Prof. Massimo Filippi

Who can join

Adults 45 to 85, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.