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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529642
• Other study ID #: JP-001
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Gait Analysis
• Physical Therapy Modalities
• Stroke

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