Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Study Overview
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Brief Summary
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This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.

Official Title
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Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Idiopathic Parkinson's Disease; Subjects should be in a positive therapeutic window or in the ON phase during the evaluations; Subjects must be able to walk at least 10 meters independently with or without any walking aid Exclusion Criteria: Non-clinically stable subjects; Subjects in OFF phase during the evaluations; Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.); Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson Disease<br>Rehabilitation according to Physiotherapy and Occupational Therapy European Guidelines for Parkinson Disease. | Other: Rehabilitation<br>* Intervention focused on balance, gait and postural transfers rehabilitation. 20 session of 90 minutes (60 minutes of physiotherapy and 30 minutes of occupational therapy), 2 times a week, for 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in execution time of Postural Transfers | The execution time is measured via an inertial measurement unit attached to the back of the patient | Change from Baseline at 10 weeks | 
| Change of execution velocity of Postural Transfers | The execution velocity is measured via an inertial measurement unit attached to the back of the patient. Specifically the velocity are measured as the Root Mean Square of gyroscope signal. | Change from Baseline at 10 weeks | 
| Change of antero-posterior acceleration during Postural Transfers execution | The antero-posterior acceleration is measured via an inertial measurement unit attached to the back of the patient. | Change from Baseline at 10 weeks | 
| Change of superior-inferior acceleration during Postural Transfers execution | The superior inferior acceleration is measured via an inertial measurement unit attached to the back of the patient. | Change from Baseline at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time Up and Go Test |  | Change from baseline at 10 weeks | 
| Change in 10 meter walking test |  | Change from baseline at 10 weeks | 
| Change in Berg Balance Scale Score |  | Change from baseline at 10 weeks | 
| Change in Short-Form 12 score |  | Change from baseline at 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Rehabilitation, Postural Transfers