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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04529642
Other study ID # JP-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date March 1, 2020

Study information

Verified date August 2020
Source Fondazione Don Carlo Gnocchi Onlus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Inertial Measurement Unit evaluation
An IMU was worn by the subjects during the execution of the 6MWT, to assess the kinematic parameters of gait.

Locations

Country Name City State
Italy IRCCS Fondazione Don Carlo Gnocchi Milan

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temporal parameters of gait Assessed through an Inertial Measurement Unit, it include the time length of steps, of the stance phase, of double and single limb support phase. 1 day
Primary Canadian Neurological Stroke Scale To state the stroke condition Baseline
Primary Berg Balance Scale To assess the balance of stroke subjects Baseline
Primary Motricity Index To assess the strength of stroke subjects Baseline
Primary Gait speed Assessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test. 1 day
Primary Meters walked The amount of meters walked in 6 minutes 1 day
Primary Step Cadence Amount of steps for each minute 1 day
Primary Symmetry AN index of the symmetry between the two sides of the subjects during gait 1 day
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