Stroke Clinical Trial
Official title:
Developing Evidence-based Parameter Selection for Locomotor Training
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.
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.
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Time Perspective: Cross-Sectional
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