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Fall Prevention in Older Adults Study

Novel Dual-Task Balance Challenge to Prevent Falls in Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03176511
Enrollment
17
Registered
2017-06-05
Start date
2017-07-25
Completion date
2018-03-30
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Fall, Postural Balance

Keywords

older adults, dual task, A Matter of Balance

Brief summary

Poor balance is one of the major risk factors for falling in older adults. A Matter of Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite its name, MOB focuses on managing concerns about falling, and does not include a balance component. We are testing to see if adding a dual-task balance component (balance and mental thinking) to MOB can improve balance and walking better, than MOB only.

Detailed description

Fall prevention interventions among community-dwelling older adults are essential. A Matter of Balance (MOB) is one of the most commonly used community-based fall prevention interventions nationally, and is considered the 'fall prevention standard of care'. MOB programs are targeted to reduce the fear of falling and promote physical activity among all older community-dwelling adults. While evidence indicates that the MOB program leads to small, sustained decreases in older adults' perceived fear of falling, there is no evidence of objectively measured balance and gait. Despite its name, MOB focuses on cognitive restructuring to manage concerns about falling, and does not include a balance component. Among community-dwelling older adults, both intact balance and concomitant attention (dual-tasking) are essential to prevent falls, and dual-task balance components are now requisite per evidence-based fall prevention intervention guidelines.

Interventions

BEHAVIORALA Matter of Balance plus Dual-Task Balance Challenge Group

Participants will receive the standard MOB classes, along with a 15-min DTBC each class, i.e., right and left foot ankle-reaching to three differently colored markers. Three colored dots are placed on the ground in an arc, using different colored stick-on dots. A chair can be placed in front of the color pattern, as needed for safety.

BEHAVIORALA Matter of Balance Group

Participants will receive the standard MOB class, taught by a certified MOB, using course materials developed by MaineHealth's Partnering for Healthy Aging (http://www.mainehealth.org/pfha).

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

As with any active intervention, participants will know their group assignment and double-blinding is not possible. Of note, our primary outcome measures are objective and require post-processing, thus study staff collecting the data will be blinded to participant results. Further, our bio-engineer post-processor will be blinded to study assignment.

Intervention model description

The proposed pilot study will employ a single-blind, two-group randomized clinical trial. We will randomly assign 24 community-dwelling older adults (≥ 60 years) from an underserved population who are at high fall risk to either: A.) 4-week MOB+DTBC intervention, or B.) 4-week MOB only intervention (n=12/group).

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Community-dwelling older adults from all sex/gender and racial/ethnic groups, aged ≥ 60 years, at high fall risk (FRQ=Fall Risk Questionnaire score \> 4), who live in the greater Tucson, AZ area.

Exclusion criteria

* Older adults currently attending MOB or other fall prevention classes (e.g. Fall Proof), having a severe mobility disorder (e.g., unable to walk 15 feet with an assistive device), severe visual or hearing impairment, non-English speaking, lack of decision-making capacity, unable to provide informed consent, serious psychiatric disorder (e.g., schizophrenia), moderately-severe depression (PHQ-9=Patient Health Questionnaire ≥ 15), cognitive impairment (MMSE=Mini-Mental Status Exam ≤ 23), or serious medical condition (e.g., cancer treatments).

Design outcomes

Primary

MeasureTime frameDescription
BalanceData will be collected at baseline and post-intervention at 4 weeks.Balance will be assessed using LEGSys™ (Locomotion Evaluation and Gait System, BioSensics LLC) wearable technology. This system uses five sensors attached to right and left anterior shins, right and left anterior thighs, and to the posterior lower back. Balance measures will include changes in sway of ankle, hip, and center of mass (COM) in both mediolateral (ML) and anterior/posterior (AP) directions while standing, with feet parallel and in semi-tandem positions, during eyes-open (EO) and eyes-closed (EC) conditions (30 seconds/test).

Secondary

MeasureTime frameDescription
GaitData will be collected at baseline and post-intervention at 4 weeks.Gait will be assessed over a distance of 20 meters using the LEGSys™ wearable technology. The system estimates spatiotemporal gait parameters including velocity, stride length, stride time, double support, single support, and stride-to-stride variability, and gait initiation. COM range of motion during walking will be calculated based on the data from the sensor attached to the lower back. Gait will be assessed under usual and maximal walking speeds.
Fear of FallingData will be collected at baseline and post-intervention at 4 weeks.Fear of Falling is defined as concerns about falling. The Falls Efficacy Scale International (FES-I) is a self-report measure that assesses concerns about falling for 16 commonly performed activities at home and in community settings (e.g. get in/out of chair, walk in crowded places).
3-month incident Fall RatesData will be collected post-intervention at months 1, 2 and 3.Participants will be provided with 3 monthly fall calendars and asked to mark it daily (X=no fall, F=Fall) and record details of any fall injury/hospitalization on the back of the monthly sheet.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026