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

NCT ID: NCT04529642

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-03-01

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.

Conditions

Stroke; Physical Therapy Modalities; Gait Analysis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Stroke Group

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

Inertial Measurement Unit evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Healthy Group

Healthy subjects age matched with the stroke group

Inertial Measurement Unit evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Inertial Measurement Unit evaluation

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Volunteers with age similar to the Stroke group subjects

Exclusion Criteria

• More than one stroke;

. Stroke area other than the cerebral cortex;

• Concomitant neurological disease and pathology of the locomotor system.

Healthy Group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi

Milan, , Italy

Countries

Italy

Other Identifiers

JP-001

Identifier Type: -

Identifier Source: org_study_id