Cerebral Hemiplegia Clinical Trial
Official title:
Falls-based Training to Improve Balance and Mobility Post-Stroke
We propose a study that uses challenging walking exercises as a research training program and compare balance and walking abilities against a non-challenging exercise program, in a group of 40 people with long standing (> 6 months) weakness that occurred after a stroke. Our main balance measure will be changes with the Berg Balance Score and Dynamic Gait Index, and our main walking measure will be walking speed over a 10 meter walkway and distance walked over a six minute period. Also, we will measure balance confidence, using scores on Activities-specific Balance Confidence Scale, changes in quality of life as measured by the Geriatric Depression Scale, SF-36 and Stroke Impact Scale. If challenging exercises are shown to be more effective than non-challenging exercises, then we will share this promising new approach with the community in hopes of improving people's lives after a stroke.
In 2009, the American Heart Association (AHA) reported that the incidence of hemiplegia in
patients six months post-stroke and over 65 years of age was 50%. Stroke survivors with
chronic hemiplegia are at an increased risk for falling due to poor motor control, muscle
weakness, and balance problems. While over-ground walking training has been shown to improve
muscle coordination and functional movement outcomes in stroke survivors, the physical
challenges to balance during the training is limited due to safety concerns. The limited
training does not reflect the individuals' natural environment, which studies have shown to
contain hazards that put post-stroke individuals at greater risk of loss of balance and
falls. Therefore, it is important for clinicians to safely implement challenging
environmental-hazard tasks as a way to effect greater improvements in walking capability
post-stroke.
The usage of body weight support (BWS) during treadmill training has been shown to improve
walking speed, but without the context of real world hazards, individuals may not gain
improvements in balance related tasks nor gain confidence in moving through hazardous
environments. The purpose of this study is to introduce a novel, falls-based training (FBT)
approach that will enable individuals to be challenged at high levels of balance and walking
safely, using a new robotic device called the KineAssist®, and to determine its relative
effects compared to traditional body weight support treadmill training (BWSTT). We
hypothesize that like the standard BWSTT, the novel FBT will result in improved walking
speed, greater 6 minute walking distance, and greater Berg Balance scores. We also
hypothesize that FBT will result in greater gains than BWSTT after the training, with a
greater difference 6 months after training. In addition to the walking tests and the Berg
Balance scale, we will compare the outcomes of the Stroke Impact Scale (SIS), the Geriatric
Depression Scale (GDS)SF-36 Health Survey, the Activities-Specific Balance Confidence (ABC)
Scale, the K-9 task Balance test, and the Dynamic Gait Index (DGI).
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