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Behavioural Intervention
Motor Learning Programs for Fall Injury Prevention
N/A
Recruiting
Led By Jacob Sosnoff, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Balance impairment as indicated by <10s on unipedal stance
No clinical osteoporosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up bbs will be assessed at all assessments (baseline, one-week post-intervention, and 3-month follow-up). each assessment will last about 1.5 hours.
Awards & highlights
Study Summary
This trial found that the current fall injury prevention techniques have merit, but are limited in effectiveness. The study focused on fall prevention, rather than mitigation of fall-related impact acceleration and forces - the "fundamental variables" for injury prevention.
Who is the study for?
This trial is for older adults with balance issues, a history of falls or fear of falling due to mobility problems. They must not have clinical osteoporosis, extensive athletic backgrounds in tumbling/gymnastics/martial arts, or engage in heavy aerobic activity. Excluded are those outside the age range, with cognitive impairments, poor unaided vision/hearing/balance, taking certain medications like blood thinners or having conditions that increase bleeding risk.Check my eligibility
What is being tested?
The study tests two programs: FAST Program and Otago Exercise Program. These aim to reduce fall-related injuries by improving how seniors react during a fall rather than just preventing falls. The effectiveness will be compared to see if these interventions can better protect against injuries from falls.See study design
What are the potential side effects?
While specific side effects aren't listed for exercise programs generally they may include muscle soreness, fatigue after sessions and an increased short-term risk of falling while learning new exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot stand on one leg for 10 seconds.
Select...
I do not have osteoporosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the outcome will measured at the baseline, one-week post-intervention, and three-months post-intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome will measured at the baseline, one-week post-intervention, and three-months post-intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determining FAST efficacy in reducing head acceleration, versus Otago Exercise Program (OEP).
Determining FAST efficacy in reducing hip impact force, versus Otago Exercise Program (OEP).
Number of adverse events
+2 moreSecondary outcome measures
The movement strategy of falls
The number of head impacts
Other outcome measures
Balance
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FAST GroupExperimental Treatment1 Intervention
Participants randomized to the intervention arm will undergo the FAST program, a progressive safe-falling training based on the tuck and roll strategy. As part of the FAST program, participants will train 30 minutes twice a week for a period of four weeks under the supervision of a trained researcher. Participants will wear protective gear (knee, hip, head) and they will complete a 10-minute stretching exercise routine to minimize the risk of injury.
Group II: Otago GroupActive Control1 Intervention
The control group will receive balance exercises adapted from the evidenced-based Otago Exercise program. Briefly, all eight sessions (~30 min) will involve balance exercises and strength exercises using ankle weights, and will progressively increase as performance improves by increasing resistance or the difficulty of the balance exercises (e.g., reducing base of support).
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,848 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,897 Total Patients Enrolled
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,242 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot stand on one leg for 10 seconds.I cannot walk around my house.I have issues with my vision, hearing, or balance that haven't been corrected.I do not have osteoporosis.I can stand on one leg for more than 10 seconds.I am currently undergoing physical therapy.I am outside the specified age range for the trial.I have a condition that increases my risk of internal bleeding.I have fallen or been afraid of falling due to balance issues in the last year.I have been diagnosed with osteoporosis.I am currently on blood thinners like coumadin, apixaban, or rivaroxaban.You do not have a history of doing activities like tumbling, gymnastics or martial arts, or currently participating in very active exercise for at least 150 minutes per week.I do not have major neurological conditions affecting my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: FAST Group
- Group 2: Otago Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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