Back to resultsExploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
Primary Purpose
Acute Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6 Minutes Walking Test
Sponsored by
About this trial
This is an interventional other trial for Acute Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Maximal Assist group
Moderate Assist group
Minimal Assist group
Supervision/Modified Independence/Independence
Arm Description
Subjects with acute stroke who ambulate with Maximal assistance of 1.
Subjects with acute stroke who ambulate with Moderate assistance of 1.
Subjects with acute stroke who ambulate with Minimal assistance of 1.
Subjects who walk without physical assistance of a helper.
Outcomes
Primary Outcome Measures
6 Minute walk test
walking endurance assessment measured in meters of total distance completed over 6 minutes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04515693
Brief Title
Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
Official Title
Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID there were limitations is performing study activities and it was decided to terminate the study.
Study Start Date
March 25, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maximal Assist group
Arm Type
Experimental
Arm Description
Subjects with acute stroke who ambulate with Maximal assistance of 1.
Arm Title
Moderate Assist group
Arm Type
Experimental
Arm Description
Subjects with acute stroke who ambulate with Moderate assistance of 1.
Arm Title
Minimal Assist group
Arm Type
Experimental
Arm Description
Subjects with acute stroke who ambulate with Minimal assistance of 1.
Arm Title
Supervision/Modified Independence/Independence
Arm Type
Experimental
Arm Description
Subjects who walk without physical assistance of a helper.
Intervention Type
Other
Intervention Name(s)
6 Minutes Walking Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 Minute walk test
Description
walking endurance assessment measured in meters of total distance completed over 6 minutes
Time Frame
8 minutes (2 minutes for set-up, 6 minutes to execute)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Karstetter, PT, DPT
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
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