Metabolic Costs of Walking Post Stroke

NCT02108912 | Completed Results DMC

• 2 other identifiers: AHA CV studyAHA Award #14CRP18500016
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic benefits for persons post stroke that learn to walk utilizing early treadmill training post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based gait training during the same time period. Participants (n=30) will be adults who have completed acute rehabilitation following a stroke. Random assignment will be to either the ESTT or traditional gait training protocol during the outpatient rehabilitation phase.

1. 1.Group A: Traditional outpatient therapy (n = 15)
2. 2.Group B: Treadmill training (ESTT) outpatient therapy (n = 15)

Conditions

Acute Stroke

Keywords

stroke; gait; cardiovascular

Outcome Measures

Primary Outcomes (2)

• Maximum Exercise Tolerance Testing

  Exercise tests will be performed with a treadmill with a static/dynamic body weight system. Measurements will be conducted with open circuit spirometry. Heart rate will be continuously monitored by electrocardiogram. Blood pressure will be monitored every 2 minutes. Participants will be allowed a 3-minute warm-up. Following the warm-up, participants will be allowed up to 10 minutes to rest or until they recovery to baseline heart rate, respiration rate and blood pressure.

  Change in exercise tolerance from enrollment to 9 weeks later and 25 weeks later

• Change in 6-Minute Walk Test Distance

  Each subject will be asked to complete a 6-Minute Walk test. They will be advised to walk at a pace they think they can maintain for the entire time. Resting is permitted provided they are not required to sit. Participants will not be given any verbal encouragement during the test. A stop watch will be used to time the test and the distance will be measured with a calibrated measuring wheel along a 150 foot corridor. Heart rate will be monitored during the test by means of a Polar chest strap and values will be recorded at each minute of the test. Perceived rate of exertion using the Borg scale of 6-20 will be recorded at rest and each minute of the test.34 Blood pressure using an automated arm cuff will be recorded before and after the test.

  At enrollment and week 25.

Other Outcomes (1)

• Temporal Spatial Gait Analysis

  At enrollment, week 9, week 17 and week 25.

Study Arms (2)

Traditional outpatient

EXPERIMENTAL

Traditional outpatient physical therapy

Other: Traditional outpatient

ESTT outpatient

EXPERIMENTAL

ESTT (early standardized task-specific training) in outpatient rehabilitation

Other: ESTT

Interventions

ESTT OTHER

ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke

ESTT outpatient

Traditional outpatient OTHER

Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices.

Traditional outpatient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of recent cerebrovascular accident (CVA) (less than 6 weeks post at the time of admission to inpatient rehabilitation)
• able to give informed consent independently or have family member or other authorized surrogate available to give consent
• first time stroke OR complete gait recovery from prior stroke
• sufficient support at home to participate in home-based fitness training program
• transportation to University of Texas Southwestern Medical Center Gait Disorders Clinic (UTSW GDC) for therapy and testing
• ability to follow one-part commands

You may not qualify if:

• non-ambulatory before onset of stroke (at time of admission to inpatient rehabilitation)
• bilateral stroke
• presence of severe cardiac problems (heart failure \[New York Heart Association \> Class 2\], unstable or exercise-induced angina)
• other co-morbidities which could affect gait training (i.e. amputation, spinal cord injury, traumatic brain injury, etc.)
• recent myocardial infarct (within 4 weeks of date of inpatient rehabilitation admission)
• any uncontrolled health condition for which exercise is contraindicated
• severe lower extremity joint disease/pathology that would interfere with gait training
• subjects -with body mass index (BMI) greater than 40
• significant cognitive impairment (less than 2 on the Functional Independence Measure \[FIM\] cognitive sub-scale)
• age greater than 80 years or less than 18 years
• able to complete 5 or more full heel raises with the affected ankle in standing with the knee extended with no more than one or two fingers on support surface for balance

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern School of Health Professions

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Karen McCain, PT, DPT, NCS
• Organization: University of Texas Southwestern Medical Center

karen.mccain@utsouthwestern.edu

214-648-1559

Study Officials

• Karen J McCain, DPT

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 9, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 1, 2019
• Results First Posted: March 1, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)