Acute StrokeNCT04515693
Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
A study testing 6 Minutes Walking Test in people with Acute Stroke, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess inter- and intra-rater reliability of the 6MWT in people with acute stroke who require various levels of assistance with walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- 6 Minutes Walking Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 31 Oct 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Primary diagnosis of an acute or hemorrhagic stroke
- Admitted into the acute or acute rehab setting and is appropriate for physical therapy services.
- Can ambulate with 1 person assistance and a device as needed, with no more than maximal assistance required. The patient must be able to independently advance the lower extremity forward, but can receive maximal assistance for blocking, bracing or postural control during ambulation.
- Can stand and/or ambulate for at least 6 minutes
Who cannot join
- Hemodynamically unstable
- Unstable medical co-morbidities such as: active bleeding, recurring seizures, uncontrolled hypertension (permissive HTN orders ok)
- Patients with bilateral acute stroke
- Patients who are unable to follow 1 step commands as determined by the screening physiatrist
- Orthopedic co-morbidities that place a weight-bearing restriction on the lower extremities such as acute fracture, joint replacement, or other musculoskeletal injury
- Any other condition that would limit a patient's ability to remain in a standing position with assistance for 6 minutes at a time.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess inter- and intra-rater reliability of the 6MWT in people with acute stroke who require various levels of assistance with walking.
- Conditions
- Acute Stroke
- Being tested
- 6 Minutes Walking Test
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Minutes Walking TestOther
A walkway of 12 meters will be marked with one cone at each end. The patient will be instructed to walk back and forth as many times as possible in six minutes.
| Study group | Role | What they receive |
|---|---|---|
| Maximal Assist group | Experimental | Subjects with acute stroke who ambulate with Maximal assistance of 1. Receives: Other: 6 Minutes Walking Test |
| Moderate Assist group | Experimental | Subjects with acute stroke who ambulate with Moderate assistance of 1. Receives: Other: 6 Minutes Walking Test |
| Minimal Assist group | Experimental | Subjects with acute stroke who ambulate with Minimal assistance of 1. Receives: Other: 6 Minutes Walking Test |
| Supervision/Modified Independence/Independence | Experimental | Subjects who walk without physical assistance of a helper. Receives: Other: 6 Minutes Walking Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute walk test
walking endurance assessment measured in meters of total distance completed over 6 minutes
Measured: 8 minutes (2 minutes for set-up, 6 minutes to execute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start25 Mar 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: Due to COVID there were limitations is performing study activities and it was decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan C. Eikenberry, P.T., D.P.T., Mayo Clinic
- Investigators
- Hannah Karstetter, PT, DPT, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515693
- Sponsor's protocol ID
- 19-010067
- Status last verified
- Jul 2022
- First submitted
- 14 Aug 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
- ClinicalTrials.gov ID
- NCT04515693
- Acronym / sponsor ID
- 19-010067
- Conditions
- Acute Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID there were limitations is performing study activities and it was decided to terminate the study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 17 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.
The purpose of this study is to assess inter- and intra-rater reliability of the 6MWT in people with acute stroke who require various levels of assistance with walking.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maximal Assist group | Experimental | Other: 6 Minutes Walking TestSubjects with acute stroke who ambulate with Maximal assistance of 1. |
| Moderate Assist group | Experimental | Other: 6 Minutes Walking TestSubjects with acute stroke who ambulate with Moderate assistance of 1. |
| Minimal Assist group | Experimental | Other: 6 Minutes Walking TestSubjects with acute stroke who ambulate with Minimal assistance of 1. |
| Supervision/Modified Independence/Independence | Experimental | Other: 6 Minutes Walking TestSubjects who walk without physical assistance of a helper. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Primary diagnosis of an acute or hemorrhagic stroke
- Admitted into the acute or acute rehab setting and is appropriate for physical therapy services.
- Can ambulate with 1 person assistance and a device as needed, with no more than maximal assistance required. The patient must be able to independently advance the lower extremity forward, but can receive maximal assistance for blocking, bracing or postural control during ambulation.
- Can stand and/or ambulate for at least 6 minutes
Key exclusion criteria (6 listed)
- Hemodynamically unstable
- Unstable medical co-morbidities such as: active bleeding, recurring seizures, uncontrolled hypertension (permissive HTN orders ok)
- Patients with bilateral acute stroke
- Patients who are unable to follow 1 step commands as determined by the screening physiatrist
- Orthopedic co-morbidities that place a weight-bearing restriction on the lower extremities such as acute fracture, joint replacement, or other musculoskeletal injury
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 |
|---|---|---|
| 6 Minutes Walking TestA walkway of 12 meters will be marked with one cone at each end. The patient will be instructed to walk back and forth as many times as possible in six minutes. | Other | Maximal Assist group, Minimal Assist group, Moderate Assist group, Supervision/Modified Independence/Independence |
Primary outcome
6 Minute walk test
Time frame: 8 minutes (2 minutes for set-up, 6 minutes to execute)
walking endurance assessment measured in meters of total distance completed over 6 minutes
Results and safety
The study was stopped early (reason given: Due to COVID there were limitations is performing study activities and it was decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hannah Karstetter, PT, DPT principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 Minutes Walking Test in people with Acute Stroke, run by Mayo Clinic at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 19 Jul 2022. 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 United States. 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 was stopped early (reason given: Due to COVID there were limitations is performing study activities and it was decided to terminate the study.). Results are not available in the source record.
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?
6 Minute walk test (time frame: 8 minutes (2 minutes for set-up, 6 minutes to execute)). 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 19 Jul 2022.