NCT06047769

Brief Summary

As age progress incidence of fall increases. Cognitively impaired patients have poor balance and they are more prone to falls. Balance and cognitive functions are co-related in middle-aged and community-dwelling elderly. In fact age-related cognitive decline as the brain ages it has exceptional neuroplasticity. To maintain balance and prevent falls various cognitive processes are required. Board games can be used as tools for cognitive training as they have the means to restore and form motor skills, cognitive functioning, and logical and spatial thinking. Cognitive training using simple games might improve the elements of balance and gait, and prevent falls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

September 14, 2023

Last Update Submit

May 19, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Berg Balance Scale (BBS)

    A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.

    Baseline

  • Berg Balance Scale (BBS)

    A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.

    After 4 weeks

  • Berg Balance Scale (BBS)

    A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.

    After 8 weeks

  • Mini-Mental State Exam (MMSE)

    A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.

    Baseline

  • Mini-Mental State Exam (MMSE)

    A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.

    After 4 weeks

  • Mini-Mental State Exam (MMSE)

    A set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory) with reliability of (0.98) and reliability (0.77). The Mini-Mental State Exam (MMSE) is a valid tool. It will be measured at baseline, 4th week and 8th week. The total score for the MMSE is 30 and a higher score means good cognition.

    After 8 weeks

Secondary Outcomes (6)

  • Dynamic Gait Index (DGI)

    Baseline

  • Dynamic Gait Index (DGI)

    After 4 weeks

  • Dynamic Gait Index (DGI)

    After 8 weeks

  • Timed Up & Go test (TUG)

    Baseline

  • Timed Up & Go test (TUG)

    After 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Interventional Group

EXPERIMENTAL

Participants will receive cognitive training in board games including Ludo, Chutes \& Ladder and Chess with both single and multiplayer modes. After 1 week of training, participants will receive intervention of 1 hour per day, three days a week for 8 weeks completing a total of 1440 minutes. With this technique, we will target the cognitive process of information processing, speed and executive function of the patient.

Other: Board Games

Control group

NO INTERVENTION

Participants will receive no intervention and will be observed for 8 weeks.

Interventions

Participants will receive cognitive training in board games including Ludo, Chutes \& Ladder and Chess with both single and multiplayer modes. After 1 week of training, participants will receive intervention of 1 hour per day, three days a week for 8 weeks completing a total of 1440 minutes. With this technique, we will target the cognitive process of information processing, speed and executive function of the patient.

Interventional Group

Eligibility Criteria

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

You may qualify if:

  • Males and Female participants aged 60 years or older.
  • Score of 26 or more on the Mini-Mental State Examination (MMSE)
  • At least one self-reported fall within the last 2 years or (BBS) score less than 52 and more than 41.
  • Subjects who are willing to commit to the time commitments required by the program.

You may not qualify if:

  • Presence of any physical limitation that may limit hand movement.
  • Presence of a severe walking or balance impairment For Example; (Amputation, or Fracture at that time.)
  • Self-reported presence of vertigo
  • Any visual disease
  • Currently using psychotropic medications.
  • Presence of any neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ABID Hospital

Islamabad, 46000, Pakistan

Location

Related Publications (5)

  • Smith-Ray RL, Hughes SL, Prohaska TR, Little DM, Jurivich DA, Hedeker D. Impact of Cognitive Training on Balance and Gait in Older Adults. J Gerontol B Psychol Sci Soc Sci. 2015 May;70(3):357-66. doi: 10.1093/geronb/gbt097. Epub 2013 Nov 5.

    PMID: 24192586BACKGROUND
  • Smith-Ray RL, Makowski-Woidan B, Hughes SL. A randomized trial to measure the impact of a community-based cognitive training intervention on balance and gait in cognitively intact Black older adults. Health Educ Behav. 2014 Oct;41(1 Suppl):62S-9S. doi: 10.1177/1090198114537068.

    PMID: 25274713BACKGROUND
  • Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.

    PMID: 17179457BACKGROUND
  • Noda S, Shirotsuki K, Nakao M. The effectiveness of intervention with board games: a systematic review. Biopsychosoc Med. 2019 Oct 21;13:22. doi: 10.1186/s13030-019-0164-1. eCollection 2019.

    PMID: 31641371BACKGROUND
  • Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.

    PMID: 19220558BACKGROUND

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

September 22, 2023

Primary Completion

December 31, 2023

Study Completion

January 30, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations