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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04529642
Enrollment
46
Registered
2020-08-27
Start date
2019-02-01
Completion date
2020-03-01
Last updated
2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Analysis, Physical Therapy Modalities, Stroke

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.

Interventions

DIAGNOSTIC_TESTInertial Measurement Unit evaluation

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

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Temporal parameters of gait1 dayAssessed 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 ScaleBaselineTo state the stroke condition
Berg Balance ScaleBaselineTo assess the balance of stroke subjects
Motricity IndexBaselineTo assess the strength of stroke subjects
Gait speed1 dayAssessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test.
Meters walked1 dayThe amount of meters walked in 6 minutes
Step Cadence1 dayAmount of steps for each minute
Symmetry1 dayAN index of the symmetry between the two sides of the subjects during gait

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026