Falls-based Training for Walking Post-Stroke

Cerebral Hemiplegia Clinical Trial

— FBT  

Official title:

Falls-based Training to Improve Balance and Mobility Post-Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787759
• Other study ID #: F120425008
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: February 22, 2018
• Start date: June 2012
• Est. completion date: January 2016

Study information

• Verified date: February 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Community dwelling unilateral stroke survivors, aged 19 years or older, 4 months to 5 years post incident, residual hemiplegia, who are able to ambulate at least 14m with an assistive device or the assistance of one person, with receptive and expressive communication capability, approval of physician, and voluntarily provided informed consent.

Exclusion Criteria:

• Significant and acute medical conditions, amputations, spasticity management that included phenol block injections within 12 months or botulinum toxin injections within 4 months of the study, any cognition involvement that impairs the ability to follow directions for, and plans to move out of the area within the next year or no transportation to the study area.

Related Conditions & MeSH terms

• Cerebral Hemiplegia
• Hemiplegia

Intervention

Other:
• Hands-Free Walking
Walking on a treadmill at 60-80% maximum heart rate without holding onto anything
• Challenge Based plus Hands-Free'
Walking on a treadmill at 60-80% maximum heart rate without holding onto anything under 9 different challenging conditions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	U.S. Department of Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 m walk test		6 weeks