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

May 4, 2020 updated by: Michael Madigan, Virginia Polytechnic Institute and State University

Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls Among Older Adults: a Pilot Randomized Controlled Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Blacksburg, Virginia, United States, 24061
        • Virginia Tech - Department of Industrial and Systems Engineering

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Slip Speed
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
highest instantaneous speed of slipping foot during actual slip
during week 1, before the intervention that spanned weeks 2 and 3
Peak Slip Speed
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
highest instantaneous speed of slipping foot during actual slip
during week 4, after the intervention that spanned weeks 2 and 3
Trunk Angle at Touchdown After Tripping
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
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
Trunk Angle at Touchdown After Tripping
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Slip Distance
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
distance moved by slipping foot during actual slip
during week 1, before the intervention that spanned weeks 2 and 3
Slip Distance
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
distance moved by slipping foot during actual slip
during week 4, after the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Slip
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
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
Fall Incidence After a Laboratory-induced Slip
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
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
Recovery Step Length After Tripping
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
anterior-posterior step distance of first step over tripping obstacle
during week 1, before the intervention that spanned weeks 2 and 3
Recovery Step Length After Tripping
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
anterior-posterior step distance of first step over tripping obstacle
during week 4, after the intervention that spanned weeks 2 and 3
Fall Incidence After a Laboratory-induced Trip
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
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
Fall Incidence After a Laboratory-induced Trip
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael L Madigan, PhD, Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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