Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population

Acute Stroke Clinical Trial

Official title:

Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04515693
• Other study ID #: 19-010067
• Status: Terminated
• Phase: N/A
• Start date: March 25, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: July 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• 6 Minutes Walking Test
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute walk test	walking endurance assessment measured in meters of total distance completed over 6 minutes	8 minutes (2 minutes for set-up, 6 minutes to execute)

External Links

•   Mayo Clinic Clinical Trials