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

Stroke Clinical Trial

Official title:

Developing Evidence-based Parameter Selection for Locomotor Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712179
• Other study ID #: A6365-R
• Status: Completed
• Phase: N/A
• First received: July 3, 2008
• Last updated: October 9, 2014
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic		During sessions- 1 day measurement	No