NCT05395676

Brief Summary

Balance stability requires both motor and cognitive (mental) functions working together. Balance stability may decrease when performing two tasks at the same time (dual task), as cognitive and motor tasks compete for performing a higher task. Meanwhile, social distance and remote working become a necessity due to Covid-19. The primary aim is to evaluate the feasibility of cognitive exergame training in reducing dual-task costs and improve the balance performance among individuals between 65 and 85 years. The secondary aim is to observe the effectiveness of virtual home exercise on adherence and interactive rate of the population between 65 and 85 years.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

Study Start

First participant enrolled

April 11, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 18, 2022

Last Update Submit

May 24, 2022

Conditions

Keywords

Balancecognitionexergamedual-taskolder adults

Outcome Measures

Primary Outcomes (2)

  • Change in Dual-task cost

    A dual-task cost (DTC) occurs when attention is divided between two tasks (e.g. cognitive and motor tasks), or a delay in one task causes attention to divert to the other. This may cause a decline in balance stability and an increase in dual-task cost. Calculation of dual-task cost A decrease in dual-task performance (i.e. dual-task cost) is represented with a negative value, whereas an improvement in dual-task performance is represented by a positive value. DTE(%)=((dual task - single task))/(single task )× 100% An example of the formula for measuring dual-task interference using absolute values of LOS parameters is DTE(%)=((dual-task LOS (RT) - single task LOS (RT)))/(single task LOS (RT)) × 100% An increase in response latency indicates a reduction in performance, thus the following will be used instead: DTE(%)=(-(dual task - single task))/(single task )× 100%

    8 weeks

  • Change in Static balance task

    The static balance is the ability to keep standing steady with eyes open and with eyes closed without losing balance or taking a step (Winter 1995). The following centre of pressure COP parameters will be computed separately for the anteroposterior (AP) and Mediolateral (ML) directions, such The COP mean velocity (MV), stander deviation (SD) and total displacement area (TD) parameters.

    8 weeks

Secondary Outcomes (8)

  • Change in Limit of stability task

    8 weeks

  • Change in Arithmetic tasks

    8 weeks

  • Change in Functional Reach (FR) Test

    8 weeks

  • Change in Visual sensitivity test

    8 weeks

  • Change in Corsi Block-Tapping Test

    8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Cognitive dual task training (CDT) Group

EXPERIMENTAL

The CDT group (n = 20) will participate in games on Xbox one consoles that require a higher cognitive demand compared to those of the BDT group. The training sessions will include five different games that require participants to stand and use their hand reach function to interact with different cognitive (i.e. dual-tasking) skills, such as working memory, problem solving, Stroop effect, planning, attention and response time.

Device: Exergame home training programme

Balance dual task (BDT) training Group

ACTIVE COMPARATOR

The BDT group (n = 20) will participate in the conventional training programme on Wii consoles that have been used by previous studies (Barcala et al. 2013; Chao et al. 2015; Kannan et al. 2019), to improve balance performance. The training sessions will include five different games that require participants to stand and use their weight shift to control the game while maintaining balance.

Device: Exergame home training programme

Interventions

Each training programme (Xbox or Wii Fit) is aimed at improving the following issues: improper weight shifting and reduced dual tasking. The participants will be guided in the first sessions to familiarize themselves with the exercises. Then, they will be allowed to exercise independently at home. Allowing enough practice time before collecting data helps minimize practice effects. practice effects are confounding factors that can affect the results and make it difficult to identify whether the improvement in outcome is due to the training or not. The duration of the training programme will be approximately 30 minutes. Each game will be played three times (the duration for each game is approximately one minute).

Balance dual task (BDT) training GroupCognitive dual task training (CDT) Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals between 65-85 years
  • Individuals with no sign of aphasia
  • Individuals with a manual muscle test score of ≤5/5
  • Individuals who can perform a full range of movement (ROM) against gravity
  • Individuals who can stand for five minutes without the use of an assistive device

You may not qualify if:

  • Individuals with a neurological condition (e.g. vestibular deficit, stroke, Parkinson's disease, epilepsy or peripheral neuropathy) o Individuals with a cardiovascular or musculoskeletal disorder
  • Individuals with any lower limb injury or balance disorder within the last 12 months that has affected their physical activity
  • Individuals with cognitive impairment such as dementia
  • Individuals who score over 13 points on the Short FES-I

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

RECRUITING

Study Officials

  • Ahmet Begde

    Loughborough University

    PRINCIPAL INVESTIGATOR
  • Alaa Algurafi

    Loughborough University

    PRINCIPAL INVESTIGATOR
  • Matthew Pain

    Loughborough University

    STUDY DIRECTOR
  • Glen Blenkinsop

    Loughborough University

    STUDY DIRECTOR
  • Eef Hogervorst

    Loughborough University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 27, 2022

Study Start

April 11, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations