Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329987
• Other study ID #: FDG_PosTrans
• Status: Recruiting
• Start date: May 18, 2022
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Riccardo Buraschi, PT
• Phone: 00390307245
• Email: rburaschi[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Rehabilitation
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.

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi	Rovato	BS

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in Time Up and Go Test		Change from baseline at 10 weeks
Secondary	Change in 10 meter walking test		Change from baseline at 10 weeks
Secondary	Change in Berg Balance Scale Score		Change from baseline at 10 weeks
Secondary	Change in Short-Form 12 score		Change from baseline at 10 weeks