NCT06056180

Brief Summary

The goal of this study \[type of study: clinical trial\] is to was planned to investigate the effect of motor imagery training given to geriatric individuals with action observation on their balance performance and to compare these two methods. The main questions it aims to answer are:

  1. 1.Is virtual reality-based balance training given together with action observation and motor imagery for six weeks in geriatric individuals more effective in improving static balance than virtual reality-based balance training given alone?
  2. 2.Is virtual reality-based balance training given together with action observation and motor imagery for six weeks in geriatric individuals more effective in improving dynamic balance than virtual reality-based balance training given alone?
  3. 3.Is virtual reality-based balance training given together with motor imagery for six weeks in geriatric individuals more effective in increasing balance confidence than virtual reality-based balance training given alone?

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

June 12, 2023

Last Update Submit

May 5, 2025

Conditions

Keywords

visual motor imagerykinesthetic motor imagerypostural controlvirtual reality therapyinteractive video gamesbalance platform with pressure sensorsurface electromyographybalance confidencefall riskmobilitycognitive processing speedsmartphone gyroscope sensor datasetaction observation

Outcome Measures

Primary Outcomes (7)

  • Measurement of Muscle Activities During Postural Swings

    EMG Biofeedback device will be used to evaluate the muscle activities in the lower leg anterior (m. tibialis anterior) and posterior group (m. gastrocnemius lateralis) muscles while performing postural swings.

    1 day before starting treatment and First day after 6 weeks of treatment (2 times in total)

  • Berg Balance Scale

    In this scale, the individual tries to maintain her balance during 14 different activities in which the center of gravity varies and is suitable for daily life activities.The total score on the Berg Balance Scale was 56. Low scores from the scale indicate a high risk of falling.

    1 day before starting treatment-First day after 6 weeks of treatment (2 times in total)

  • Portable computerized kinesthetic balance device of participants' static and dynamic balance

    Static and dynamic balance will be evaluated while participants stand on one or two legs on the device (eyes open/closed, in 9 different conditions). The Balance Index Score (DI) displayed on the screen as a result of the test will be recorded as the individual's balance score. The score range is 0-6000. 0 is the best score.

    1 day before starting treatment-First day after 6 weeks of treatment (2 times in total)

  • 10 meter Walking Test

    How long it takes individuals to walk a distance of 10 meters will be recorded in seconds.

    1 day before starting treatment-First day after 6 weeks of treatment (2 times in total)

  • Activity-Specific Balance Confidence Scale

    The Activity-Specific Balanced Confidence Scale will be used to measure balance confidence. The total score ranges from 0 to 100, with higher scores indicating greater confidence.

    1 day before starting treatment and First day after 6 weeks of treatment (2 times in total)

  • Movement Imagination Questionnaire-3

    In the questionnaire consisting of 12 items, kinesthetic, internal and external visual imagination abilities are evaluated separately.Higher scores on the survey indicate better mental imagery ability.

    1 day before starting treatment-First day after 6 weeks of treatment (2 times in total)

  • Mental Stopwatch Test

    Time Up and Go Test (TUG) will be used to look at the temporal similarity between the durations of real and imagined movement in geriatric individuals. Both test results will be recorded in seconds. The temporal harmony between real and imagined movement will be calculated in delta time. Higher delta time indicates lower motor imagery ability.

    1 day before starting treatment-First day after 6 weeks of treatment (2 times in total)

Study Arms (2)

Balance Training+ Action Observation Training + Motor İmagery Training

EXPERIMENTAL

The study group (23 cases) will be given motor imagery training and virtual reality-based balance training along with action observation.

Other: Balance TrainingOther: Motor İmagery TrainingOther: Action Observation Training

Balance Training

ACTIVE COMPARATOR

Only virtual reality-based balance training will be given to the control group (23 cases).

Other: Balance Training

Interventions

Participants will be given static and dynamic balance training with a balance platform game console (20 minutes) containing interactive video games based virtual reality for a total of 6 weeks.

Balance TrainingBalance Training+ Action Observation Training + Motor İmagery Training

For motor imagery training, two visualization scenarios will be created: anterior and posterior motor imagery. One of the visualization scenarios appropriate to each individual's needs will be used. Participants will be asked to perform kinesthetic or visual motor imagery in accordance with the scenario they listened to (10 minutes).

Balance Training+ Action Observation Training + Motor İmagery Training

Action observation training will be done using video modeling method. The video content will include Nintendo Wii games in which the games that the person will play in that session are played by someone else and successful scores are achieved (10 minutes).

Balance Training+ Action Observation Training + Motor İmagery Training

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be between 60-80 years old
  • Having the ability to speak, read, understand and write Turkish
  • To have the cognitive skills to understand and apply the trainings to be applied in the study (with ≥ 24 points from the Mini Mental State Test)
  • Being able to do activities of daily living independently
  • Being able to walk independently (without using a walking aid and at least 10 meters)
  • Having a body mass index of \<35 kg/m2 (not being severely obese or morbidly obese)

You may not qualify if:

  • Having visual, hearing and sensory impairment
  • To have had a trauma, lesion or surgery that may affect balance and musculoskeletal system in the last 6 months
  • Having a history of 2 ≥ falls in the last 6 months
  • Having any chronic lower extremity pain
  • Having an acute or chronic illness that may cause problems with balance and falling
  • Being diagnosed with sensory, vestibular and cerebellar ataxia
  • Being on any medication that may cause problems with balance, focus, attention and falling.
  • Exercising regularly, which may affect performance results
  • To stop participating in the study for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University

Menteşe, Muğla, 48050, Turkey (Türkiye)

RECRUITING

Study Officials

  • Şeyda Ercan Yüceer

    Mugla Sitki Kocman Univercity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Şeyda Ercan Yüceer

CONTACT

Mehmet Gürhan Karakaya

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The person among the researchers who will evaluate the individuals will be blinded to the treatment. The person who will make the statistical evaluations of the data will be blind to the treatment and evaluations to be made to the individuals.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 12, 2023

First Posted

September 28, 2023

Study Start

November 1, 2023

Primary Completion

May 1, 2025

Study Completion

December 1, 2025

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations