Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

Sponsor
Fondazione Don Carlo Gnocchi Onlus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05329987
Collaborator
(none)
20
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Analysis of Postural Transitions in Subjects Affected by Parkinson Disease
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Parkinson Disease

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

  3. 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.

  4. 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.

Secondary Outcome Measures

  1. Change in Time Up and Go Test [Change from baseline at 10 weeks]

  2. Change in 10 meter walking test [Change from baseline at 10 weeks]

  3. Change in Berg Balance Scale Score [Change from baseline at 10 weeks]

  4. Change in Short-Form 12 score [Change from baseline at 10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Riccardo Buraschi, PT, IRCCS Fondazione Don Carlo Gnocchi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier:
NCT05329987
Other Study ID Numbers:
  • FDG_PosTrans
First Posted:
Apr 15, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondazione Don Carlo Gnocchi Onlus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022