Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

NCT05329987 | Completed

• 1 other identifier: FDG_PosTrans
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Rehabilitation; Postural Transfers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (1)

Parkinson Disease

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

Other: Rehabilitation

Interventions

Rehabilitation OTHER

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.

Parkinson Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of subjects affected by Parkinson Disease

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi

Rovato, BS, 25038, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Riccardo Buraschi, PT

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 15, 2022
• Study Start: May 18, 2022
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

IT (1)