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

Not Applicable

Terminated

• Conditions: Acute Stroke
• Interventions: Other: 6 Minutes Walking Test

• Registration Number: NCT04515693
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-25
• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-17
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal Assist group	6 Minutes Walking Test	Subjects with acute stroke who ambulate with Minimal assistance of 1.
Supervision/Modified Independence/Independence	6 Minutes Walking Test	Subjects who walk without physical assistance of a helper.
Moderate Assist group	6 Minutes Walking Test	Subjects with acute stroke who ambulate with Moderate assistance of 1.
Maximal Assist group	6 Minutes Walking Test	Subjects with acute stroke who ambulate with Maximal assistance of 1.

Primary Outcome Measures

Name	Time	Method
6 Minute walk test	8 minutes (2 minutes for set-up, 6 minutes to execute)	walking endurance assessment measured in meters of total distance completed over 6 minutes

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States