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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Physical Therapy Modalities; Gait Analysis
• Intervention / Treatment: Diagnostic test: Inertial Measurement Unit evaluation

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20148
    • Irccs Fondazione Don Carlo Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stroke Group:

Post stroke subjects who were referred to the centre for rehabilitation, and were able to independently walk with or without an assistive device.

Healthy Group:

Healthy controls age-matched with the subjects in the stroke group

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.
Healthy Group; Healthy subjects age matched with the stroke group	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: JP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No