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

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 Overview

• Status: Terminated
• Conditions: Acute Stroke
• Intervention / Treatment: Other: 6 Minutes Walking Test

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85054
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maximal Assist group; Subjects with acute stroke who ambulate with Maximal assistance of 1.	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.
Experimental: Moderate Assist group; Subjects with acute stroke who ambulate with Moderate assistance of 1.	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.
Experimental: Minimal Assist group; Subjects with acute stroke who ambulate with Minimal assistance of 1.	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.
Experimental: Supervision/Modified Independence/Independence; Subjects who walk without physical assistance of a helper.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Hannah Karstetter, PT, DPT, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 19-010067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No