NCT05923385

Brief Summary

The aim of our study is to reveal whether static and dynamic balance tests can be an indicator of deterioration in cognitive impairments in geriatric individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

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

June 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

June 19, 2023

Last Update Submit

December 18, 2024

Conditions

Keywords

geriatriacognitive statusbalance test

Outcome Measures

Primary Outcomes (3)

  • Standardized Mini Mental Test

    The mini mental test is a test that can be administered by a physician, nurse, psychologist or a healthcare professional with a short training. It is a practical mental test in terms of applicability that can show the cognitive level globally. Evaluates cognitive performance quantitatively. It is important in terms of examining the course of dementia cases and their response to treatment in the clinic. There are 11 items in the test gathered around 5 main headings. These items are; Orientation is register memory, attention and calculation, recall and language. The total score is evaluated out of 30. A score of 25 and above is considered normal. Between 10 and 19 is moderate dementia. Between 19-24 refers to early dementia (13,14).

    5 minutes

  • Four Step Square Test

    The test clinically assesses the ability to change direction while taking a step. At the start of the test, the patient stands in the upper left square (Frame 1) and looks in the direction of Square 2. First, the step sequence is clockwise: Square 1, then Squares 2, 4, and 3. Then the step sequence is counterclockwise: square 3, followed by squares 4, 2, and 1. The physiotherapist demonstrates the test and allows the patient to apply the model to learn the sequence. The test is repeated if the patient fails to complete the sequence successfully or loses balance or touches the cane. Two points are obtained and the better of these two points is recorded. Timed effort begins when the first foot touches the ground at Square 2 and then ends when the patient's second foot touches the ground at Square 1 (15, 16, 17).

    8 minutes

  • Timed Up and Get Test

    The test assesses functional mobility, balance, and performance in adults 65 years and older. Wearing normal shoes and walking aids, the patient begins the test in a standard seat with his back against the chair, his arms resting on the arms of the chair, and both feet flat on the floor. The patient is instructed to stand up and walk to a line on the ground at a distance of 3 m, turn on the line, walk back to the chair and sit on the chair. The test ends when the patient's hip touches the seat. The test is repeated twice; The fastest time is recorded. It is classified as mobile for \<10 s, general independent for \<20 s, and limited mobility for \>30 s (15, 16, 18).

    5 minutes

Secondary Outcomes (2)

  • One Leg Standing Test (Eyes Open and Eyes Closed):

    3 minutes

  • Functional Reach Test:

    4 minutes

Interventions

Four Square Step TestDIAGNOSTIC_TEST

These are standardized test which will be applied to subjects with pencil, paper and time recorder.

Also known as: Timed Get Up and Go Test, One Leg Standing Test (Eyes Open and Eyes Closed), Standardized Mini Mental Test, Functional Reach Test

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Relative healthy nursing home residents aged 65-85 living in the nursing home will be included in the study.

You may qualify if:

  • Relative, healthy elderly individuals aged 65-85 years
  • Individuals who do not have neurological / orthopedic problems that will prevent them from performing the test
  • Independent elderly individuals in activities of daily living
  • Men and women living in a nursing home
  • No pre-defined vision and hearing problems
  • No history of lower extremity or lumbar spinal surgery

You may not qualify if:

  • Hadkinson's Abbreviated Mental Test less than 7 points
  • Presence of defined neurological, orthopedic, systemic (cardiovascular) disease that interferes with walking and mobility
  • Presence of defined psychiatric illness
  • Having a communication problem
  • Presence of using aids for walking
  • Use of prostheses or orthoses associated with the lower extremity
  • Presence of cognitive, visual or auditory impairment
  • Balance-affected individuals with lower extremity disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

  • Thapa PB, Gideon P, Fought RL, Kormicki M, Ray WA. Comparison of clinical and biomechanical measures of balance and mobility in elderly nursing home residents. J Am Geriatr Soc. 1994 May;42(5):493-500. doi: 10.1111/j.1532-5415.1994.tb04970.x.

    PMID: 8176143BACKGROUND
  • Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis: II. Cardiac and analgesic drugs. J Am Geriatr Soc. 1999 Jan;47(1):40-50. doi: 10.1111/j.1532-5415.1999.tb01899.x.

    PMID: 9920228BACKGROUND
  • Boyd R, Stevens JA. Falls and fear of falling: burden, beliefs and behaviours. Age Ageing. 2009 Jul;38(4):423-8. doi: 10.1093/ageing/afp053. Epub 2009 May 6.

    PMID: 19420144BACKGROUND
  • Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

    PMID: 12794644BACKGROUND
  • Duncan RP, Earhart GM. Four square step test performance in people with Parkinson disease. J Neurol Phys Ther. 2013 Mar;37(1):2-8. doi: 10.1097/NPT.0b013e31827f0d7a.

    PMID: 23364168BACKGROUND
  • Shubert TE, McCulloch K, Hartman M, Giuliani CA. The effect of an exercise-based balance intervention on physical and cognitive performance for older adults: a pilot study. J Geriatr Phys Ther. 2010 Oct-Dec;33(4):157-64.

    PMID: 21717919BACKGROUND
  • Gunendi Z, Ozyemisci-Taskiran O, Demirsoy N. The effect of 4-week aerobic exercise program on postural balance in postmenopausal women with osteoporosis. Rheumatol Int. 2008 Oct;28(12):1217-22. doi: 10.1007/s00296-008-0651-3. Epub 2008 Jul 22.

    PMID: 18648815BACKGROUND
  • Harrison JK, McArthur KS, Quinn TJ. Assessment scales in stroke: clinimetric and clinical considerations. Clin Interv Aging. 2013;8:201-11. doi: 10.2147/CIA.S32405. Epub 2013 Feb 18.

    PMID: 23440256BACKGROUND
  • Stevenson TJ, Garland SJ. Standing balance during internally produced perturbations in subjects with hemiplegia: validation of the balance scale. Arch Phys Med Rehabil. 1996 Jul;77(7):656-62. doi: 10.1016/s0003-9993(96)90004-0.

    PMID: 8669991BACKGROUND
  • Schulz BW, Hart-Hughes S, Gordon MT, Bulat T. Training implications of maximal forces on a computer-controlled and motor-driven leg press by age group, sex, footplate direction, and speed. Exp Gerontol. 2012 Apr;47(4):295-303. doi: 10.1016/j.exger.2012.01.003. Epub 2012 Jan 20.

    PMID: 22289381BACKGROUND

Study Officials

  • Guzin Kaya Aytutuldu, PT,PhD.

    Biruni University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

June 19, 2023

First Posted

June 28, 2023

Study Start

August 15, 2023

Primary Completion

September 15, 2023

Study Completion

February 12, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations