Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls

NCT ID: NCT04308239

Last Updated: 2020-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Accidental Fall

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Reactive balance training

Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant.

Reactive balance training involved both slip and trip training.

Slip training involved repeatedly stepping onto a low-friction interface (nylon fabric placed over a 0.9 × 0.9 meter polycarbonate sheet) while practicing controlling/decelerating the slipping foot and properly positioning the non-slipping foot under the pelvis.

Trip training involved repeatedly practicing recovery from simulated trips on a modified treadmill. While standing on a modified treadmill, the treadmill belt was quickly accelerated posteriorly to elicit a forward loss of balance that mimicked a trip while walking. Participants attempted to step to avert a fall, and to establish a stable gait on the treadmill, after which the treadmill speed was slowed to zero to complete the trial.

Group Type EXPERIMENTAL

Reactive balance training

Intervention Type BEHAVIORAL

Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations.

Control balance training

Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant.

The control intervention involved general balance exercises adapted from the Otago Exercise program. Briefly, all four sessions involved balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).

Group Type ACTIVE_COMPARATOR

Otago Balance Training

Intervention Type BEHAVIORAL

Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).

Interventions

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Reactive balance training

Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations.

Intervention Type BEHAVIORAL

Otago Balance Training

Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

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Michael Madigan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael L Madigan, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

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Virginia Tech - Department of Industrial and Systems Engineering

Blacksburg, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32532221 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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18-486

Identifier Type: -

Identifier Source: org_study_id

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