Stroke Clinical Trial
Official title:
Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment? A Pilot Observational Study
NCT number | NCT04529642 |
Other study ID # | JP-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2019 |
Est. completion date | March 1, 2020 |
Verified date | August 2020 |
Source | Fondazione Don Carlo Gnocchi Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Fondazione Don Carlo Gnocchi | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Canadian Neurological Stroke Scale | To state the stroke condition | Baseline | |
Primary | Berg Balance Scale | To assess the balance of stroke subjects | Baseline | |
Primary | Motricity Index | To assess the strength of stroke subjects | Baseline | |
Primary | Gait speed | Assessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test. | 1 day | |
Primary | Meters walked | The amount of meters walked in 6 minutes | 1 day | |
Primary | Step Cadence | Amount of steps for each minute | 1 day | |
Primary | Symmetry | AN index of the symmetry between the two sides of the subjects during gait | 1 day |
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