Clinical trial NCT04308239: Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls
Official title: Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls Among Older Adults: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Keywords: balance training
step training
perturbation-based balance training
dynamic balance
aging
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-group, pretest-posttest parallel design was employed. Participants were first assigned to either the reactive balance training or control intervention using minimization. During the first week, participants completed a pre-intervention assessment involving exposure to a single laboratory-induced slip or trip based upon random assignment. During the second and third weeks, participants completed a total of four sessions of their assigned intervention (two sessions per week for two weeks). During the fourth week, participants completed a post-intervention assessment involving exposure to the other perturbation (slip or trip) that they did not experience during the pre-intervention assessment. This design was selected to evaluate gait and reactive balance prior to any training intervention, and to avoid any unintended training effects induced by exposing participants to the same perturbation more than once.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak Slip Speed
timeFrame: during week 1, before the intervention that spanned weeks 2 and 3
measure: Peak Slip Speed
timeFrame: during week 4, after the intervention that spanned weeks 2 and 3
measure: Trunk Angle at Touchdown After Tripping
timeFrame: during week 1, before the intervention that spanned weeks 2 and 3
measure: Trunk Angle at Touchdown After Tripping
timeFrame: during week 4, after the intervention that spanned weeks 2 and 3
Secondary outcomes:
measure: Slip Distance
timeFrame: during week 1, before the intervention that spanned weeks 2 and 3
measure: Slip Distance
timeFrame: during week 4, after the intervention that spanned weeks 2 and 3
measure: Fall Incidence After a Laboratory-induced Slip
timeFrame: during week 1, before the intervention that spanned weeks 2 and 3
measure: Fall Incidence After a Laboratory-induced Slip
timeFrame: during week 4, after the intervention that spanned weeks 2 and 3
measure: Recovery Step Length After Tripping
timeFrame: during week 1, before the intervention that spanned weeks 2 and 3
measure: Recovery Step Length After Tripping
timeFrame: during week 4, after the intervention that spanned weeks 2 and 3
measure: Fall Incidence After a Laboratory-induced Trip
timeFrame: during week 1, before the intervention that spanned weeks 2 and 3
measure: Fall Incidence After a Laboratory-induced Trip
timeFrame: during week 4, after the intervention that spanned weeks 2 and 3
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech - Department of Industrial and Systems Engineering
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Michael L Madigan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allin LJ, Brolinson PG, Beach BM, Kim S, Nussbaum MA, Roberto KA, Madigan ML. Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial. BMC Geriatr. 2020 Jun 12;20(1):205. doi: 10.1186/s12877-020-01605-9.