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Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05329987
Enrollment
23
Registered
2022-04-15
Start date
2022-05-18
Completion date
2024-08-01
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Rehabilitation, Postural Transfers

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.

Interventions

OTHERRehabilitation

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.

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Change of superior-inferior acceleration during Postural Transfers executionChange from Baseline at 10 weeksThe superior inferior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Change in execution time of Postural TransfersChange from Baseline at 10 weeksThe execution time is measured via an inertial measurement unit attached to the back of the patient
Change of execution velocity of Postural TransfersChange from Baseline at 10 weeksThe 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 executionChange from Baseline at 10 weeksThe antero-posterior acceleration is measured via an inertial measurement unit attached to the back of the patient.

Secondary

MeasureTime frame
Change in Time Up and Go TestChange from baseline at 10 weeks
Change in 10 meter walking testChange from baseline at 10 weeks
Change in Berg Balance Scale ScoreChange from baseline at 10 weeks
Change in Short-Form 12 scoreChange from baseline at 10 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026