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

NCT04308239 | Completed Results

• 1 other identifier: 18-486
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Fall

Keywords

balance training; step training; perturbation-based balance training; dynamic balance; aging

Outcome Measures

Primary Outcomes (4)

• Peak Slip Speed

  highest instantaneous speed of slipping foot during actual slip

  during week 1, before the intervention that spanned weeks 2 and 3

• Peak Slip Speed

  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

  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

  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 Outcomes (8)

• Slip Distance

  during week 1, before the intervention that spanned weeks 2 and 3

• Slip Distance

  during week 4, after the intervention that spanned weeks 2 and 3

• Fall Incidence After a Laboratory-induced Slip

  during week 1, before the intervention that spanned weeks 2 and 3

• Fall Incidence After a Laboratory-induced Slip

  during week 4, after the intervention that spanned weeks 2 and 3

• Recovery Step Length After Tripping

  during week 1, before the intervention that spanned weeks 2 and 3

Study Arms (2)

Reactive balance training

EXPERIMENTAL

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.

Behavioral: Reactive balance training

Control balance training

ACTIVE COMPARATOR

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).

Behavioral: Otago Balance Training

Interventions

Reactive balance training 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.

Reactive balance training

Otago Balance Training 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).

Control balance training

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• smoked
• were in physical therapy
• had a self-reported fragility fracture within the last 10 years
• had an acute lower extremity injury within the last 3 months
• had lower extremity surgery within the last six months
• had an ankle arthroplasty
• had a knee or hip arthroplasty within the last 12 months

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Tech - Department of Industrial and Systems Engineering

Blacksburg, Virginia, 24061, United States

Location

Related Publications (1)

• 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.

  PMID: 32532221 DERIVED

Limitations and Caveats

All training and assessment sessions were conducted by a single investigator who was not blinded to participant group.

Results Point of Contact

• Title: Michael Madigan
• Organization: Virginia Tech

mlm@vt.edu

(540) 231-3543

Study Officials

• Michael L Madigan, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 16, 2020
• Study Start: June 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 18, 2020
• Results First Posted: May 18, 2020

Record last verified: 2020-03

Locations

US (1)