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

Mayo Clinic

Status: Terminated

Conditions: Acute Stroke

Treatments: Other: 6 Minutes Walking Test

Study type: Interventional

Funder types: Other

Identifiers

NCT04515693

19-010067

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 4 patient groups

Maximal Assist group

Experimental group

Description:

Subjects with acute stroke who ambulate with Maximal assistance of 1.

Treatment:

Other: 6 Minutes Walking Test

Moderate Assist group

Experimental group

Description:

Subjects with acute stroke who ambulate with Moderate assistance of 1.

Treatment:

Other: 6 Minutes Walking Test

Minimal Assist group

Experimental group

Description:

Subjects with acute stroke who ambulate with Minimal assistance of 1.

Treatment:

Other: 6 Minutes Walking Test

Supervision/Modified Independence/Independence

Experimental group

Description:

Subjects who walk without physical assistance of a helper.

Treatment:

Other: 6 Minutes Walking Test