NCT07150364

Brief Summary

Cognitive decline and balance issues are key contributors to falls. Square Stepping Exercise (SSE) and Wobble Board Exercise (WBE) both are the promising forms of balance training. Therefore, the aim of this study is to compare these two exercises to determine their effects on cognition, balance, and fall risk in elderly population.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

November 17, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 24, 2025

Last Update Submit

August 24, 2025

Conditions

Keywords

BalanceCognitionFall riskSquare-stepping exerciseWobble board

Outcome Measures

Primary Outcomes (3)

  • Fall Efficacy Scale- international (FES- I)

    The FES-I is designed to assess concern about falling while performing basic and instrumental indoor and outdoor activities. This scale consists of 16 items (10 items from the original FES and six additional social activities items). Each item is scored with a four- point scale (1 = not concerned at all, 4 = very concerned). The summation of scores gives a total score from 16 (absence of FOF) to 64 (extreme concern of falling). This scale was used as a criterion scale in the present study with a cutoff point of 23.

    6th week

  • Mini Mental State Examination (MMSE)

    The Mini-Mental State Examination (MMSE) is a widely used tool for screening cognitive function and assessing the severity of cognitive impairment. It assesses areas such as orientation, registration, attention and calculation, recall, language, and visual construction. The MMSE consists of 30 questions with a maximum score of 30 points in which score between 24-30 is consider normal, score 18-23 is consider mild cognitive impairment and score between 0-17 is consider severe cognitive impairment.

    6th week

  • Berg Balance Scale (BBS)

    The BBS evaluates a participant's balance based on 14 items scored and takes 15-20 min to complete. The score for each item ranges from 0 to 4 points, with an overall maximum score of 56 points. Balance is evaluated by asking participants to perform a variety of sitting, transferring and standing positions. In an assessment of which cut- off scores on the BBS best predict the risk of falling. The score of 41-56 indicates low risk of fall, 21-40 indicates medium risk of fall, and 0-20 indicates the high risk of fall.

    6th week

Secondary Outcomes (1)

  • Time up and Go test (TUG)

    6th week

Study Arms (2)

Square Stepping Exercise

EXPERIMENTAL

In SSE, step patterns are performed on a mat

Other: Square Stepping Exercise

Wobble Board Exercise

EXPERIMENTAL

Person is standing on a wobble board, that unexpectedly translates or tilts

Other: Wobble Board Exercise

Interventions

5 days per week for 6 weeks. 30 minutes per session with appropriate rest interval in between.

Square Stepping Exercise

5 days per week for 6 weeks. 30 minutes per session with appropriate rest interval in between.

Wobble Board Exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly individuals age 60 years and above of both genders according to the guidelines of World Health Organization (WHO).
  • Participants whose Mini Mental State Examination (MMSE) score will be \>24/30 ensuring sufficient cognitive ability to follow instructions and participate in exercise.
  • Participants whose Berg Balance Scale scores of more than 41/56 ensuring that the participants have moderate level of balance ability.
  • Vital signs within normal range for elderly population.
  • Ability to walk independently with or without an assistive device (e.g., canes).

You may not qualify if:

  • Participants who have severe musculoskeletal or neurological disorders affecting gait or balance (e.g., Parkinson's disease, and stroke) because of the complex impacts of these conditions on general cognitive and physical functions.
  • Participants who undergoes recent fractures or injuries affecting participation in physical activity.
  • Participants who have uncontrolled cardiovascular or metabolic conditions (e.g., uncontrolled hypertension, and diabetes mellitus) that could significantly interfere with exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khursheed Old Home

Lahore, Punjab Province, 54800, Pakistan

RECRUITING

Related Publications (14)

  • Delbaere K, Valenzuela T, Lord SR, Clemson L, Zijlstra GAR, Close JCT, Lung T, Woodbury A, Chow J, McInerney G, Miles L, Toson B, Briggs N, van Schooten KS. E-health StandingTall balance exercise for fall prevention in older people: results of a two year randomised controlled trial. BMJ. 2021 Apr 6;373:n740. doi: 10.1136/bmj.n740.

    PMID: 33824131BACKGROUND
  • Forbes PA, Chen A, Blouin JS. Sensorimotor control of standing balance. Handb Clin Neurol. 2018;159:61-83. doi: 10.1016/B978-0-444-63916-5.00004-5.

    PMID: 30482333BACKGROUND
  • Guirguis-Blake JM, Michael YL, Perdue LA, Coppola EL, Beil TL. Interventions to Prevent Falls in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 Apr 24;319(16):1705-1716. doi: 10.1001/jama.2017.21962.

    PMID: 29710140BACKGROUND
  • Henry M, Baudry S. Age-related changes in leg proprioception: implications for postural control. J Neurophysiol. 2019 Aug 1;122(2):525-538. doi: 10.1152/jn.00067.2019. Epub 2019 Jun 5.

    PMID: 31166819BACKGROUND
  • Franzel K, Koschate J, Freiberger E, Shigematsu R, Zieschang T, Tietgen S. Square-stepping exercise in older inpatients in early geriatric rehabilitation. A randomized controlled pilot study. BMC Geriatr. 2024 Apr 10;24(1):326. doi: 10.1186/s12877-024-04932-3.

    PMID: 38600478BACKGROUND
  • Thomas E, Battaglia G, Patti A, Brusa J, Leonardi V, Palma A, Bellafiore M. Physical activity programs for balance and fall prevention in elderly: A systematic review. Medicine (Baltimore). 2019 Jul;98(27):e16218. doi: 10.1097/MD.0000000000016218.

    PMID: 31277132BACKGROUND
  • Kawabata M, Gan SR, Shen-Hsing AC. Effects of Square Stepping Exercise on cognitive, physical, psychological, and group functioning in sedentary older adults: A center-based hybrid trial. BMC Geriatr. 2024 Apr 25;24(1):374. doi: 10.1186/s12877-024-04904-7.

    PMID: 38664613BACKGROUND
  • Taghavi Asl A, Shojaedin SS, Hadadnezhad M. Comparison of effect of wobble board training with and without cognitive intervention on balance, ankle proprioception and jump landing kinetic parameters of men with chronic ankle instability: a randomized control trial. BMC Musculoskelet Disord. 2022 Sep 30;23(1):888. doi: 10.1186/s12891-022-05706-x.

    PMID: 36180870BACKGROUND
  • Rudnicka E, Napierala P, Podfigurna A, Meczekalski B, Smolarczyk R, Grymowicz M. The World Health Organization (WHO) approach to healthy ageing. Maturitas. 2020 Sep;139:6-11. doi: 10.1016/j.maturitas.2020.05.018. Epub 2020 May 26.

    PMID: 32747042BACKGROUND
  • Meimandi M, Fadavi-Ghaffari M, Taghizadeh G, Azad A, Lajevardi L. Falls Efficacy Scale and Single Item Question: Screening Accuracy for Older Adults Residing in Nursing Homes. Clin Gerontol. 2021 Oct-Dec;44(5):544-551. doi: 10.1080/07317115.2020.1858467. Epub 2020 Dec 15.

    PMID: 33320074BACKGROUND
  • Dewan N, MacDermid JC. Fall Efficacy Scale-International (FES-I). J Physiother. 2014 Mar;60(1):60. doi: 10.1016/j.jphys.2013.12.014. Epub 2014 May 3. No abstract available.

    PMID: 24856947BACKGROUND
  • Patnode CD, Perdue LA, Rossom RC, Rushkin MC, Redmond N, Thomas RG, Lin JS. Screening for Cognitive Impairment in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2020 Feb 25;323(8):764-785. doi: 10.1001/jama.2019.22258.

    PMID: 32096857BACKGROUND
  • Meekes WM, Korevaar JC, Leemrijse CJ, van de Goor IA. Practical and validated tool to assess falls risk in the primary care setting: a systematic review. BMJ Open. 2021 Sep 29;11(9):e045431. doi: 10.1136/bmjopen-2020-045431.

    PMID: 34588228BACKGROUND
  • Zahedian-Nasab N, Jaberi A, Shirazi F, Kavousipor S. Effect of virtual reality exercises on balance and fall in elderly people with fall risk: a randomized controlled trial. BMC Geriatr. 2021 Sep 25;21(1):509. doi: 10.1186/s12877-021-02462-w.

    PMID: 34563120BACKGROUND

Study Officials

  • Fatima Tariq

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 2, 2025

Study Start

November 17, 2024

Primary Completion

November 30, 2025

Study Completion

January 30, 2026

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations