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

Completed

• Conditions: Stroke; Gait Analysis; Physical Therapy Modalities
• Interventions: Diagnostic Test: Inertial Measurement Unit evaluation

• Registration Number: NCT04529642
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-08-27
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke Group	Inertial Measurement Unit evaluation	Inclusion criteria were as follows: age above 18, Mini-Mental State Examination ≥ 24, ability to provide written informed consent and to understand the test instructions, and the presence of a single stroke. Exclusion criteria were as follows: more than one stroke, stroke area other than the cerebral cortex, or concomitant neurological disease and pathology of the locomotor system. This group has been analysed also dividing the subjects according to the stroke phase in 3 subgroups: Acute phase group, Subacute phase group, Chronic stroke group
Healthy Group	Inertial Measurement Unit evaluation	Healthy subjects age matched with the stroke group

Primary Outcome Measures

Name	Time	Method
Motricity Index	Baseline	To assess the strength of stroke subjects
Gait speed	1 day	Assessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test.
Step Cadence	1 day	Amount of steps for each minute
Meters walked	1 day	The amount of meters walked in 6 minutes
Symmetry	1 day	AN index of the symmetry between the two sides of the subjects during gait
Temporal parameters of gait	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.
Canadian Neurological Stroke Scale	Baseline	To state the stroke condition
Berg Balance Scale	Baseline	To assess the balance of stroke subjects

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Milan, Italy