Proactive and Reactive Perturbation Training to Reduce Falls and Improve Gait Stability in People With Chronic Stroke

Medical University of South Carolina1 site in 1 country86 target enrollmentOctober 6, 2021

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Medical University of South Carolina
Enrollment: 86
Locations: 1
Primary Endpoint: Fall incidence
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.

Registry

clinicaltrials.gov

Start Date

October 6, 2021

End Date

December 5, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of South Carolina

Responsible Party

Principal Investigator

Jesse Dean

Associate Professor

Medical University of South Carolina

Eligibility Criteria

Inclusion Criteria

•Experience of a stroke at least 6 months prior to participation
•Self-reported experience of a fall in the previous year, and/or a fear of falling
•Gait speed of at least 0.2 m/s
•Ability to walk on a treadmill without a cane or walker
•Provision of informed consent

Exclusion Criteria

•Evidence of cerebellar damage
•Resting blood pressure higher than 220/110 mm Hg
•History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
•Preexisting neurological disorders or dementia
•Legal blindness or severe visual impairment
•History of DVT or pulmonary embolism within 6 months
•Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
•Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern

Outcomes

Primary Outcomes

Fall incidence

Time Frame: 32 weeks (12-week period pre-intervention; 12-week period post-intervention)

A fall will be defined as an event in which a participant loses their balance and comes to rest on the ground, floor, or lower level. Falls will be measured during the 12-week periods preceding and following the intervention, using 2-week calendars on postcards to be sent to the investigators.

Secondary Outcomes

Activities-specific Balance Confidence scale(8 weeks (pre-intervention; post-intervention))
Foot placement stabilization strategy (gluteus medius activity)(8 weeks (pre-intervention; post-intervention))
Walking speed(8 weeks (pre-intervention; post-intervention))
Fear of falling(8 weeks (pre-intervention; post-intervention))
Push-off stabilization strategy (mechanics)(8 weeks (pre-intervention; post-intervention))
Push-off stabilization strategy (medial gastrocnemius activity)(8 weeks (pre-intervention; post-intervention))
Functional Gait Assessment(8 weeks (pre-intervention; post-intervention))
Center of pressure shift stabilization strategy (mechanics)(8 weeks (pre-intervention; post-intervention))
Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))
Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))
Foot placement stabilization strategy (mechanics)(8 weeks (pre-intervention; post-intervention))
Center of pressure shift stabilization strategy (peroneus longus activity)(8 weeks (pre-intervention; post-intervention))
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))