Understanding Different Parameters in Locomotor Training (a Type of Walking Training) for Person After a Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00712179
First received: July 3, 2008
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

This is a research study to understand how people who have experienced a stroke walk in order to develop better and more effective types of therapy. Data collected from people who have experienced a stroke and healthy individuals will be used to compare a neurologically healthy person to someone, which has sustained an injury.


Condition
Stroke

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Developing Evidence-based Parameter Selection for Locomotor Training

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • diagnostic [ Time Frame: During sessions- 1 day measurement ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2008
Study Completion Date: December 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Detailed Description:

The first day will be a chance for you to become familiar with the body weight support (BWS) system and walking at different speeds. This first day will last about 2 hours and will consistent of fifteen total minutes of locomotor training utilizing manual trainers. This means trainers will move your body into a more normal walking pattern. You will be given a chance to rest between bouts; however, you may also rest at any point.

First, you will walk for five minutes at your normal comfortable speed with 15% of your body weight supported through an overhead system. This will be followed by walking at speeds faster and slower than your comfortable speed. After these initial bouts of stepping, will be the training bouts. Training will be conducted with 30% of your body weight supported and at speeds considered normal for adults. Trainers will assist the trunk and with each leg, and will assist with initiation of steps and leg positioning, maintenance of an upright trunk, pelvic rotation, and weight shift. Training will consist of three bouts of five minutes of stepping for a total duration of 15 minutes of stepping. Vital signs, heart rate and blood pressure, will be monitored after each 5-minute bout. If you wear an Ankle Foot Orthosis (AFO), you will be asked to walk without it, but we will provide you with an Aircast, which supports the ankle and prevents it from rolling side to side, but allows the foot to move freely up and down ,

Data will be collected on the second day. This will take approximately five hours. During this time you will be asked to walk on the ground and on a treadmill. For the overground portion, you will walk across a 14-foot level, pressure-sensitive walkway at your own speed and then as fast as you can safely. This walkway measures the speed of your walking and the size of your steps. You can use any assistive device that you typically use. A physical therapist or trained assistant will walk beside you as you walk across the walkway. You will be asked to walk several times across the walkway at the two speeds while recordings are made from your muscles and you are videotaped.

You will also be asked to walk on a treadmill. You will be permitted to practice treadmill walking until you feel comfortable. Once you feel comfortable we will ask you to walk a couple different ways. The order will be random, and the speeds will be determined from your first visit. You will be asked to walk some with Body Weight Support and some without. We will ask you to walk at your comfortable speed and then as fast as you can safely walk. You will also walk at these same speeds and percentage of body weight support while trainers help you step in a way as close to normal.

You will be able to rest at any point and for as long as you wish, however, after each trial you will be required to rest at least 2 minutes.

During all treadmill walking, you will wear a harness attached to a mobile device attached to the ceiling. This device is for safety to prevent a fall and it can catch you should you lose your balance or stumble. It will also be used to provide body weight support for some of the walking trials. If you use braces and/or assistive devices, you will be asked to do some walking with and without them, according to your comfort and safety. A therapist will walk with you to provide any physical assistance you may need.

For the walking testing, we may need to shave small areas of your legs to attach small sensors to your skin to measure the electrical activity of your leg muscles. We will also attach reflective markers or small angle measurement devices to the skin over your hips and several locations on your legs. We will film your movements with video cameras.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy Controls and persons who have sustained a stroke

Criteria

Inclusion Criteria:

  • adults at least 18 years old;
  • able to provide informed consent;
  • able to follow three-step motor command;
  • have a single unilateral stroke;
  • medically stable (i.e. asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with walking;
  • able to stand with assistance and/or ambulate 15 meters with or without an assistive device or brace and no greater than standby physical assistance.

Exclusion Criteria:

  • weight > 300 pounds due to limitations in body weight support systems;
  • body size which is incompatible with harnesses;
  • pregnancy;
  • presence of significant musculoskeletal problems that limit hip and knee extension or ankle plantarflexion to neutral;
  • self selected walking speed below 0.3 m/s; and
  • history of congestive cardiac failure, unstable angina, or peripheral vascular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712179

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
Principal Investigator: Steve A. Kautz, PhD MS BS Ralph H. Johnson VA Medical Center, Charleston, SC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00712179     History of Changes
Other Study ID Numbers: A6365-R
Study First Received: July 3, 2008
Last Updated: October 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stroke
walking
Treadmill
body weight support system

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014