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

NCT04515693 | Terminated

• 1 other identifier: 19-010067
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (4)

Maximal Assist group

EXPERIMENTAL

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

Other: 6 Minutes Walking Test

Moderate Assist group

EXPERIMENTAL

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

Other: 6 Minutes Walking Test

Minimal Assist group

EXPERIMENTAL

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

Other: 6 Minutes Walking Test

Supervision/Modified Independence/Independence

EXPERIMENTAL

Subjects who walk without physical assistance of a helper.

Other: 6 Minutes Walking Test

Interventions

6 Minutes Walking Test OTHER

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.

Maximal Assist group; Minimal Assist group; Moderate Assist group; Supervision/Modified Independence/Independence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85054, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hannah Karstetter, PT, DPT

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 17, 2020
• Study Start: March 25, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)