NCT02404129

Brief Summary

As the geriatric population continues to rise, the consequences of falls and fall-related injuries carry increasing socioeconomic significance. Fall during turning is 7.9 times more likely to result in hip fracture than a fall while walking straight. Hence, turning carries a significant risk for hip fracture. Turning is ubiquitous during activities of daily living, yet most gait research has focused on straight ahead walking. Turning affects lower limb kinematics, kinetics, and step parameters. Therefore it appears to be a greater challenge for individuals with mobility problems. Turning ability is affected by age changes and balance confidence. TURN180 test was built to assess the parameters of turning. It has four major categories which are the most readily identified indictors of difficulty in turning while walking. These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn. The purpose of this study is to explore the TURN180 test ability to evaluate the risk of falling in the elderly population and compare it to the known gold standard clinical test. This is a validation study of balance and mobility tests using a three-group sample of convenience. The independent elderly subjects (n=75) will be divided into three groups according to their falls history and undergo four balance tests: Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be videotaped while performing the TUG test. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn will be measured using both the slow-motion and stop-action capabilities of the VCR system and a time-code processor.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 12, 2015

Last Update Submit

March 26, 2015

Conditions

Keywords

FallTurn 180 testelderlybalance

Outcome Measures

Primary Outcomes (1)

  • Validity of TURN 180 Test

    TURN180 test was built to assess the parameters of turning. A Turn is defined as the beginning and end of the 180-degree reversal of direction at the turn line on the floor while walking. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn is measured. The test has four major categories which are the most readily identified indicators of difficulty in turning while walking. These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn. The 4 characteristics developed to reflect a continuum from "no difficulty" to "definite indicators of difficulty" while turning during walking: The score in each category is from 0 to 2 points, so getting 0 points means - having no difficulty in turning and 8 points - severe difficulty in turning.

    Each participant in the study will be assessed once. Sesion duration time - 1 hour.

Secondary Outcomes (3)

  • Tinneti Balance Assessment Tool

    Each participant in the study will be assessed once. Sesion duration time - 1 hour.

  • Berg Balance Scale

    Each participant in the study will be assessed once. Sesion duration time - 1 hour.

  • Time up and go (TUG)

    Each participant in the study will be assessed once. Sesion duration time - 1 hour.

Study Arms (3)

Non-fallers

OTHER

The subjects had to report having no difficulties with mobility, activities of daily living, or turning while walking and had no falls for a year period. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale.

Other: Turn 180 test

In a risk to fall

OTHER

Subjects who report about 1-2 falls in a year period. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale.

Other: Turn 180 test

Multiple fallers

OTHER

Subjects who reported to have more than two falls per year. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale.

Other: Turn 180 test

Interventions

The purpose of this study is to explore the TURN180 test ability to evaluate the risk of falling in the elderly population and compare it to the known gold standard clinical tests. The independent elderly subjects will be divided into three groups according to their falls history and undergo four balance tests: Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be videotaped while performing the TUG test. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn will be measured using both the slow-motion and stop-action capabilities of the VCR system and a time-code processor.

Also known as: Timed " Up and Go" test ( TUG), Tinetti Balanced test, Berg Balance Scale (BBS)
In a risk to fallMultiple fallersNon-fallers

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older, man and woman.
  • Independent, and community dwelling.
  • Able to give informed consent.
  • Able to ambulate inside under close supervision for a distance of 10 m.

You may not qualify if:

  • Visual impairment that cannot be fixed by glasses.
  • Acute cardiopulmonary conditions (MI, Acute asthma).
  • S/p Myocardial infarction within last 3 month.
  • Severe congestive heart failure.
  • Neurologic pathologies (CVA, MS, Parkinson's Disease).
  • S/p Amputation of lower limb.
  • Vertigo.
  • Acute low back pain, acute ankle/knee/hip joint inflammation or arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy

Petah Tikva, Israel

Location

Related Publications (5)

  • Nevitt MC, Cummings SR. Type of fall and risk of hip and wrist fractures: the study of osteoporotic fractures. The Study of Osteoporotic Fractures Research Group. J Am Geriatr Soc. 1993 Nov;41(11):1226-34. doi: 10.1111/j.1532-5415.1993.tb07307.x.

    PMID: 8227898BACKGROUND
  • Cumming RG, Klineberg RJ. Fall frequency and characteristics and the risk of hip fractures. J Am Geriatr Soc. 1994 Jul;42(7):774-8. doi: 10.1111/j.1532-5415.1994.tb06540.x.

    PMID: 8014355BACKGROUND
  • Glaister BC, Bernatz GC, Klute GK, Orendurff MS. Video task analysis of turning during activities of daily living. Gait Posture. 2007 Feb;25(2):289-94. doi: 10.1016/j.gaitpost.2006.04.003. Epub 2006 May 26.

    PMID: 16730441BACKGROUND
  • Dite W, Temple VA. Development of a clinical measure of turning for older adults. Am J Phys Med Rehabil. 2002 Nov;81(11):857-66; quiz 867-8. doi: 10.1097/00002060-200211000-00010.

    PMID: 12394998BACKGROUND
  • Thigpen MT, Light KE, Creel GL, Flynn SM. Turning difficulty characteristics of adults aged 65 years or older. Phys Ther. 2000 Dec;80(12):1174-87.

    PMID: 11087304BACKGROUND

Study Officials

  • Cohen Av Herman, Proffesor

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cohen Av Herman, Proffesor

CONTACT

Gamerman Yulia, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor MD

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 31, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations