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

Study Overview
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Brief Summary
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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.

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

Conditions
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Physical Therapy Modalities, Gait Analysis, Stroke

Intervention / Treatment
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* Diagnostic Test: Inertial Measurement Unit evaluation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke Group<br>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 | Diagnostic Test: Inertial Measurement Unit evaluation<br>* An IMU was worn by the subjects during the execution of the 6MWT, to assess the kinematic parameters of gait.<br>|
| Healthy Group<br>Healthy subjects age matched with the stroke group | Diagnostic Test: Inertial Measurement Unit evaluation<br>* An IMU was worn by the subjects during the execution of the 6MWT, to assess the kinematic parameters of gait.<br>|

What is the study measuring?
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Primary Outcome Measures

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