University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Location status: Recruiting
NCT Number: NCT06396650
The target population of this project is older people with high risks of falls. About 30% community-dwelling individuals over 65 years of age fall each year and the rate of fall related injuries leading to loss of function and independence increases with age. Falls are the leading cause of fatal and non-fatal injuries and the leading cause traumatic brain injury in older adults. Slip-related falls in older adults comprise 40% of outdoor falls and are the leading cause of hip fracture or traumatic head injury. In 2012, 2.4 million non-fatal falls were treated in emergency room visits with $30 billion dollars spent on direct medical costs. In addition to fractures and traumatic brain injury, nonfatal falls frequently lead to reduced levels of activity, fear of falling, and reduced quality of life. Clearly, advancing the predictive, preventative, and rehabilitative methods aimed at reducing the risk of injurious falls in this population is imperative. Although falls are multi-factorial in nature, there has been few individualized assessment of the biomechanical causes of falls.
The purpose of this study is to conduct subject-specific training on older adults with fall risks with combined home-hospital rehabilitation. This project will involve rehabilitation interventions based on the characteristics of falling patterns and older adults with reduced capability controlling the balance. To conduct subject-specific fall prevention training. based on identified individual fall mechanisms.
Interested in participating?
Request Info60 year–85 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
Location status: Recruiting
Forty older adults (study group) with high risk of fall (i.e. with one or more fall in the past 12 months) will be recruited. The fall mechanisms will be examined in previous Aims 1 and 2 part of this study.
Assessments will be conducted to identify the fall risks and falling mechanisms by measuring subjects' responses to the movements of the footplates the subject stands on. Training procedures will then be designed for each subject, including training both in the research lab (once per week) and at home (three times per week) for six weeks. The subject will also revisit the lab for a follow-up assessment two months after the 6-week training.
Based on the identified falling mechanisms, a specific training for each subject will be set up using the sliding stepping fall rehabilitation system for one session per week over six weeks in the lab. The participants will also do home training exercises 3 times per week after initial in-lab instructed training. Participants will come to the lab and have biomechanical and clinical evaluations before and after the 6-week training (called Pre & Post), and then at a two-month follow-up as the final evaluation for total three times of evaluations.
All the subjects will be informed about the experimental procedures, and sign an IRB approved consent form prior to study participation and experimental tests.
All participants will be protected from the risk of falling with a harness system. The harness is mounted in mobile cart. A researcher will push the mobile cart following the participant's walking while walking on the ground.
Home-based training: The older adults will also undergo corresponding home-based training. Training at home may include normal walking and strength training based on the results in-lab assessments for each older adult and research team instructions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the weekly lab-based training session, the subject will do individualized training using the sliding stepping trainer, with a focus on the direction the subject showed higher risks of falling, as identified in the initial assessment. The sliding stepping trainer will generate perturbations of the footplates in those identified risky directions during stepping.
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Berg Balance Scale (BBS) evaluation will be used which provides a value for fall risks assessment.
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
The lower limb muscle strength will be measured manually by a researcher using dynamometry
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Subjects' ground impact forces captured by forces plates during multidirectional perturbations during walking.
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Subjects' body kinematics measured by wearable IMUs during multidirectional perturbations during walking.
Time frame: The first visit, immediately after the training, and a follow-up evaluation session two-month after the training
Subjects' body reactions to multidirectional perturbations during walking. Reactions include loss of balance, recovery steps, and falls, which will be identified by videos.
Contact information is provided by the study sponsor or research team.
University of Maryland, Baltimore
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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