Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Rehabilitation

• Registration Number: NCT05329987
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-15
• Study Start: 2022-05-18
• Primary Completion: 2024-04-01
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson Disease	Rehabilitation	Rehabilitation according to Physiotherapy and Occupational Therapy European Guidelines for Parkinson Disease.

Primary Outcome Measures

Name	Time	Method
Change of execution velocity of Postural Transfers	Change from Baseline at 10 weeks	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 of antero-posterior acceleration during Postural Transfers execution	Change from Baseline at 10 weeks	The antero-posterior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Change of superior-inferior acceleration during Postural Transfers execution	Change from Baseline at 10 weeks	The superior inferior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Change in execution time of Postural Transfers	Change from Baseline at 10 weeks	The execution time is measured via an inertial measurement unit attached to the back of the patient

Secondary Outcome Measures

Name	Time	Method
Change in 10 meter walking test	Change from baseline at 10 weeks
Change in Time Up and Go 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

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi; 🇮🇹 Rovato, BS, Italy