Brief Summary

Background: Dynamic balance keeps the vertical projection of the center of mass within the base of support while the center of mass moves. The age-related decrease in dynamic balance is a risk factor for falls. Dynamic balance tests are used to predict the risks for falls and eventual falls but the psychometric properties of most tests assessing dynamic balance are unsatisfactory and comprise no actual loss of balance while walking. Objectives: Using beam walking distance as a measure of dynamic balance, we will determine the psychometric properties, lifespan and patient reference values, the relationship with selected 'dynamic balance tests', and the accuracy of beam walking distance to predict falls. Methods: This cross-sectional observational study will examine healthy adults in 7 decades (n=432) at 4 centers. Center 5 will examine patients (n=100) diagnosed with Parkinson's disease, multiple sclerosis, stroke, and balance disorders. At Test 1, all participants will be measured for demographics, medical history, grip and leg strength, short physical performance battery, static balance on a force platform, and dynamic balance using beam walking (4m-long, 4, 8, and 12 cm wide) under single (beam walking only) and dual task conditions (beam walking while concurrently performing an arithmetic task). In addition, cognitive function (global cognition, attention, executive function, processing speed, memory) will be assessed. Patients and healthy participants age 50+ will be additionally measured for fear of falling, history of falls, miniBESTest, functional reach on a force platform, timed up and go, and reactive balance. At Test 2, 7-10 days after Test 1, healthy adults young and age 50+ (n=40) will be re-tested for reliability of beam walking performance. All participants age 50+ will be re-called to report fear of falling and fall history 6 and 12 months after Test 1. Conclusion: The investigators expect to find that beam walking performance vis-à-vis the traditionally used balance outcomes predicts more accurately fall risks and falls.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

432

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2018

Geographic Reach

5 countries

5 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

April 27, 2018

Completed

25 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed

10 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed

Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

April 27, 2018

Last Update Submit

May 9, 2018

Conditions

Aging Parkinson Disease Stroke Dementia Diagnoses Disease Cognitive Impairment Postural; Defect

Outcome Measures

Primary Outcomes (1)

distance in balance beam walking under single and dual-task conditions
Outcomes are the sum of length traversed (3-5 trials, 4m each, 12m maximum), average velocity, number of steps, and average step length determined from video tape recordings (60Hz) made at 90° relative to the walking direction with full beam length in view using off-the-shelf HD video cameras (Kinovea software).
2 hours

Secondary Outcomes (17)

Physical activity
10 minutes
Fall history
10 minutes
Falls efficacy scale-international
10 minutes
Balance confidence
15 minutes
Mini-BESTest
20 minutes
+12 more secondary outcomes

Study Arms (8)

adults aged 20-29

adults aged 30-39

adults aged 40-49

adults aged 50-59

healthy adults will perform the following tests: Functional tests Mini BESTest Mobility, SPPB Static balance Proactive balance (Reach, TUG) Reactive balance Dynamic balance (beam test to predict falls) Grip, leg strength Cognitive tests Global cognition Attention, executive f. Processing speed Memory In the follow up study 6, 12 months after baseline, fear of falling and fall history will be assessed in 50+