StrokeNCT04529642
Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment?
An observational study of Stroke and Physical Therapy Modalities, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Physical Therapy Modalities, Gait Analysis
- What is being tested?
- Inertial Measurement Unit evaluation
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Age >= 18;
- Mini-Mental State Examination ≥ 24;
- Ability to provide written informed consent and to understand the test instructions;
- Presence of a single stroke.
- Volunteers with age similar to the Stroke group subjects
Who cannot join
- More than one stroke;
- . Stroke area other than the cerebral cortex;
- Concomitant neurological disease and pathology of the locomotor system.
- Healthy Group
- Any disease that could affect the performance in terms of metres walked and quality of gait.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke, Physical Therapy Modalities, Gait Analysis
- Being tested
- Inertial Measurement Unit evaluation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inertial Measurement Unit evaluationDiagnostic test
An IMU was worn by the subjects during the execution of the 6MWT, to assess the kinematic parameters of gait.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Inertial Measurement Unit evaluation | |
| Healthy Group | Healthy subjects age matched with the stroke group Receives: Diagnostic Test: Inertial Measurement Unit evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Canadian Neurological Stroke Scale
To state the stroke condition
Measured: Baseline
Berg Balance Scale
To assess the balance of stroke subjects
Measured: Baseline
Motricity Index
To assess the strength of stroke subjects
Measured: Baseline
Gait speed
Assessed through an Inertial Measurement Unit, in different moments of the 6-Minute walking test.
Measured: 1 day
Meters walked
The amount of meters walked in 6 minutes
Measured: 1 day
Step Cadence
Amount of steps for each minute
Measured: 1 day
Symmetry
AN index of the symmetry between the two sides of the subjects during gait
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Feb 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529642
- Sponsor's protocol ID
- JP-001
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment? A Pilot Observational Study
- ClinicalTrials.gov ID
- NCT04529642
- Acronym / sponsor ID
- JP-001
- Conditions
- Stroke, Physical Therapy Modalities, Gait Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Group | – | Diagnostic Test: Inertial Measurement Unit evaluationInclusion 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 |
| Healthy Group | – | Diagnostic Test: Inertial Measurement Unit evaluationHealthy subjects age matched with the stroke group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Age >= 18;
- Mini-Mental State Examination ≥ 24;
- Ability to provide written informed consent and to understand the test instructions;
- Presence of a single stroke.
- Volunteers with age similar to the Stroke group subjects
Key exclusion criteria (5 listed)
- More than one stroke;
- . Stroke area other than the cerebral cortex;
- Concomitant neurological disease and pathology of the locomotor system.
- Healthy Group
- Any disease that could affect the performance in terms of metres walked and quality of gait.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inertial Measurement Unit evaluationAn IMU was worn by the subjects during the execution of the 6MWT, to assess the kinematic parameters of gait. | Diagnostic test | Healthy Group, Stroke Group |
Primary outcome
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
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.
Meters walked
Time frame: 1 day
The amount of meters walked in 6 minutes
Step Cadence
Time frame: 1 day
Amount of steps for each minute
Symmetry
Time frame: 1 day
AN index of the symmetry between the two sides of the subjects during gait
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Physical Therapy Modalities, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal parameters of gait (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.