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Completed

NCT Number: NCT05329987

Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Don Carlo Gnocchi

Rovato, BS, 25038, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. Change in execution time of Postural Transfers

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Time Up and Go Test

    Time frame: Change from baseline at 10 weeks

  2. Change in 10 meter walking test

    Time frame: Change from baseline at 10 weeks

  3. Change in Berg Balance Scale Score

    Time frame: Change from baseline at 10 weeks

  4. Change in Short-Form 12 score

    Time frame: Change from baseline at 10 weeks

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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