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Clinical Trials/NCT04529642
NCT04529642
Completed
N/A

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

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country46 target enrollmentFebruary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
46
Locations
1
Primary Endpoint
Motricity Index
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
March 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

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.

Outcomes

Primary Outcomes

Motricity Index

Time Frame: Baseline

To assess the strength of stroke subjects

Gait speed

Time Frame: 1 day

Assessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test.

Step Cadence

Time Frame: 1 day

Amount of steps for each minute

Meters walked

Time Frame: 1 day

The amount of meters walked in 6 minutes

Symmetry

Time Frame: 1 day

AN index of the symmetry between the two sides of the subjects during gait

Temporal parameters of gait

Time Frame: 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

Time Frame: Baseline

To state the stroke condition

Berg Balance Scale

Time Frame: Baseline

To assess the balance of stroke subjects

Study Sites (1)

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