NCT04285164

Brief Summary

Falls are a significant public health concern for older adults; early identification of people at high risk for falling facilitates the provision of rehabilitation treatment to reduce future fall risk. Berg balance scale is a reliable, valid and widely used tool to measure balance. Normal values of BBS declines with increasing age above 70 at a rate of 0.75 points per year. Timed up and go test Assess mobility, balance, falls risk. Normative data on both these test for our population is not established. Therefore this study aimed at finding normal scores of both these in our community-dwelling elderly females. For this purpose, data will be calculated from community-dwelling elderly females. BBS and TUG would be performed on each subject meeting our inclusion criteria after their consent. Data will be recorded and analyzed using Statistical Package for the Social Sciences (SPSS) version 23. We will find the mean and standard deviation. Thus this study will provide normal reference values of BBS and TUG in our community

Trial Health

87
On Track

Trial Health Score

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

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

February 24, 2020

Last Update Submit

March 29, 2021

Conditions

Keywords

fallsFrail Eldersbalance

Outcome Measures

Primary Outcomes (2)

  • Berg balance scale

    Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing \_\_\_\_\_ Standing unsupported \_\_\_\_\_ Sitting unsupported \_\_\_\_\_ Standing to sitting \_\_\_\_\_ Transfers \_\_\_\_\_ Standing with eyes closed \_\_\_\_\_ Standing with feet together \_\_\_\_\_ Reaching forward with outstretched arm \_\_\_\_\_ Retrieving object from floor \_\_\_\_\_ Turning to look behind \_\_\_\_\_ Turning 360 degrees \_\_\_\_\_ Placing alternate foot on stool \_\_\_\_\_ Standing with one foot in front \_\_\_\_\_ Standing on one foot \_\_\_\_\_ TOTAL \_\_/56

    day 1

  • Timed up and go test

    Timed up and go test is used for the assessment of falls risk among elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: \<10 seconds = normal \<20 seconds = good mobility, can go out alone, mobile without a gait aid \<30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.

    day 1

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailselderly females
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community-dwelling older adult females who are able to walk independently and can take self-care activities independently without any cognitive issues \& any co-morbidity.

You may qualify if:

  • Community-dwelling older adults aged 60-80 years
  • only females
  • Tolerance of balance and gait tasks without fatigue
  • Able to walk independently Get in or out of a chair with or without assistive device
  • Independent in self-care activities (eating, bathing, dressing)
  • Able to follow instructions in able to perform the test required in the study

You may not qualify if:

  • Elderly individuals with a history of recurrent falls
  • Cognitive and neurological impairments
  • History of transitory ischemic attack
  • stroke Participants on a wheelchair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (8)

  • Wang CY, Hsieh CL, Olson SL, Wang CH, Sheu CF, Liang CC. Psychometric properties of the Berg Balance Scale in a community-dwelling elderly resident population in Taiwan. J Formos Med Assoc. 2006 Dec;105(12):992-1000. doi: 10.1016/S0929-6646(09)60283-7.

    PMID: 17185241BACKGROUND
  • Downs S, Marquez J, Chiarelli P. Normative scores on the Berg Balance Scale decline after age 70 years in healthy community-dwelling people: a systematic review. J Physiother. 2014 Jun;60(2):85-9. doi: 10.1016/j.jphys.2014.01.002. Epub 2014 Jun 13.

    PMID: 24952835BACKGROUND
  • Patterson KK, Inness E, McIlroy WE, Mansfield A. A Retrospective Analysis of Post-Stroke Berg Balance Scale Scores: How Should Normal and At-Risk Scores Be Interpreted? Physiother Can. 2017;69(2):142-149. doi: 10.3138/ptc.2015-73.

    PMID: 28539694BACKGROUND
  • Muir-Hunter SW, Clark J, McLean S, Pedlow S, Van Hemmen A, Montero Odasso M, Overend T. Identifying balance and fall risk in community-dwelling older women: the effect of executive function on postural control. Physiother Can. 2014 Spring;66(2):179-86. doi: 10.3138/ptc.2013-16.

    PMID: 24799756BACKGROUND
  • Herman T, Giladi N, Hausdorff JM. Properties of the 'timed up and go' test: more than meets the eye. Gerontology. 2011;57(3):203-10. doi: 10.1159/000314963. Epub 2010 May 20.

    PMID: 20484884BACKGROUND
  • Ibrahim A, Singh DKA, Shahar S. 'Timed Up and Go' test: Age, gender and cognitive impairment stratified normative values of older adults. PLoS One. 2017 Oct 3;12(10):e0185641. doi: 10.1371/journal.pone.0185641. eCollection 2017.

    PMID: 28972994BACKGROUND
  • Carling A, Forsberg A, Nilsagård Y. "Berg Balance Scale" and "Timed Up and Go" discriminates between fallers and non-fallers, in people with MS. InSixth International Symposium on Gait and Balance in Multiple Sclerosis, Portland, OR, US, and September 9-10, 2016 2016.

    BACKGROUND
  • Muir SW, Berg K, Chesworth B, Speechley M. Use of the Berg Balance Scale for predicting multiple falls in community-dwelling elderly people: a prospective study. Phys Ther. 2008 Apr;88(4):449-59. doi: 10.2522/ptj.20070251. Epub 2008 Jan 24.

    PMID: 18218822BACKGROUND

Study Officials

  • Arshad Nawaz Malik, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

July 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations