Accidental Fall Clinical Trial
Official title:
Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls Among Older Adults: a Pilot Randomized Controlled Trial
NCT number | NCT04308239 |
Other study ID # | 18-486 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | July 1, 2019 |
Verified date | March 2020 |
Source | Virginia Polytechnic Institute and State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study was to evaluate the effects of reactive balance training (RBT) targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build upon prior work, the present study included: 1) a control group receiving an alternative balance training intervention; 2) separate training and assessment sessions; 3) alternative RBT methods that may be more amenable to work outside the lab compared to prior methods, and 4) older adult participants receiving individualized training to reduce drop-out. The investigators hypothesized that slips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial slips before any intervention or after a control intervention. The investigators also hypothesized that trips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial trips before any intervention or after a control intervention. Results were intended to contribute to knowledge regarding the efficacy of alternative methods for RBT, and provide additional evidence regarding its efficacy.
Status | Completed |
Enrollment | 34 |
Est. completion date | July 1, 2019 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1) pass a medical history and screening administered by a physician that excluded participants with osteoporosis of the lumbar spine or proximal femur as assessed by Dual Energy X-ray Absorptiometry (Lunar iDXA, GE Healthcare, Chicago, IL), or any unstable or progressive medical conditions that could contribute to imbalance or falls Exclusion Criteria: 1. smoked 2. were in physical therapy 3. had a self-reported fragility fracture within the last 10 years 4. had an acute lower extremity injury within the last 3 months 5. had lower extremity surgery within the last six months 6. had an ankle arthroplasty 7. had a knee or hip arthroplasty within the last 12 months |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Tech - Department of Industrial and Systems Engineering | Blacksburg | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Polytechnic Institute and State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak Slip Speed | highest instantaneous speed of slipping foot during actual slip | during week 1, before the intervention that spanned weeks 2 and 3 | |
Primary | Peak Slip Speed | highest instantaneous speed of slipping foot during actual slip | during week 4, after the intervention that spanned weeks 2 and 3 | |
Primary | Trunk Angle at Touchdown After Tripping | anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle | during week 1, before the intervention that spanned weeks 2 and 3 | |
Primary | Trunk Angle at Touchdown After Tripping | anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle | during week 4, after the intervention that spanned weeks 2 and 3 | |
Secondary | Slip Distance | distance moved by slipping foot during actual slip | during week 1, before the intervention that spanned weeks 2 and 3 | |
Secondary | Slip Distance | distance moved by slipping foot during actual slip | during week 4, after the intervention that spanned weeks 2 and 3 | |
Secondary | Fall Incidence After a Laboratory-induced Slip | the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted | during week 1, before the intervention that spanned weeks 2 and 3 | |
Secondary | Fall Incidence After a Laboratory-induced Slip | the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted | during week 4, after the intervention that spanned weeks 2 and 3 | |
Secondary | Recovery Step Length After Tripping | anterior-posterior step distance of first step over tripping obstacle | during week 1, before the intervention that spanned weeks 2 and 3 | |
Secondary | Recovery Step Length After Tripping | anterior-posterior step distance of first step over tripping obstacle | during week 4, after the intervention that spanned weeks 2 and 3 | |
Secondary | Fall Incidence After a Laboratory-induced Trip | the outcome of each trip was categorized as a: fall, recovery, or harness-assisted | during week 1, before the intervention that spanned weeks 2 and 3 | |
Secondary | Fall Incidence After a Laboratory-induced Trip | the outcome of each trip was categorized as a: fall, recovery, or harness-assisted | during week 4, after the intervention that spanned weeks 2 and 3 |
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