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Completed

NCT Number: NCT04529642

Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment?

This Observational study aims at the evaluation of stroke subjects with an inertial measurement unit (IMU) during the execution of a 6-Minute Walking test, to evaluate the associations between the kinematic parameters retrieved trough an IMU and the classical outcome scales. Moreover compare the stroke subjects with age-matched healthy subjects, and detect the differences of gait kinematic.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Analysis Nervous System Diseases Physical Therapy Modalities Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Stroke Group

Inclusion criteria

  • Age >= 18;
  • Mini-Mental State Examination ≥ 24;
  • Ability to provide written informed consent and to understand the test instructions;
  • Presence of a single stroke.

Exclusion criteria

  • More than one stroke;

. Stroke area other than the cerebral cortex;

  • Concomitant neurological disease and pathology of the locomotor system.

Healthy Group

Inclusion criteria

  • Volunteers with age similar to the Stroke group subjects

Exclusion criteria

  • Any disease that could affect the performance in terms of metres walked and quality of gait.

Treatment and study plan

Inertial Measurement Unit evaluation

Diagnostic Test

An IMU was worn by the subjects during the execution of the 6MWT, to assess the kinematic parameters of gait.

Primary outcomes

  1. Temporal parameters of gait

    Time frame: 1 day

    Assessed through an Inertial Measurement Unit, it include the time length of steps, of the stance phase, of double and single limb support phase.

  2. Canadian Neurological Stroke Scale

    Time frame: Baseline

    To state the stroke condition

  3. Berg Balance Scale

    Time frame: Baseline

    To assess the balance of stroke subjects

  4. Motricity Index

    Time frame: Baseline

    To assess the strength of stroke subjects

  5. Gait speed

    Time frame: 1 day

    Assessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test.

  6. Meters walked

    Time frame: 1 day

    The amount of meters walked in 6 minutes

  7. Step Cadence

    Time frame: 1 day

    Amount of steps for each minute

  8. Symmetry

    Time frame: 1 day

    AN index of the symmetry between the two sides of the subjects during gait

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment? A Pilot Observational Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Aug 27, 2020

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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