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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06056180
Other study ID # MSKUSYuceer_001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date June 2025

Study information

Verified date December 2023
Source Mugla Sitki Koçman University
Contact Seyda Ercan Yüceer
Phone +905070202276
Email seydaercan22@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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. 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. 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? 46 geriatric individuals will be randomized into 2 groups. Along with action observation, motor imagery training and virtual reality-based balance training will be given to the study group. On the other hand, only virtual reality-based balance training will be given to the control group. All assessments will be repeated before and after the trainings. The trainings will be applied 2 days a week for 6 weeks. Each training session; 25 minutes for the control group and 45 minutes for the study group.


Description:

Muscle strength, proprioception, joint mobility, vestibular losses and vision losses may occur with the aging process. These losses may lead to a decrease in the ability of geriatric individuals to adapt to environmental factors. This loss of harmony may cause balance disorders in individuals by affecting static and dynamic postural control performance. Looking at the literature, balance trainings, functional exercises, flexibility, muscle strength and endurance trainings, Tai Chi, Qigong-like yoga exercises, dance, walking programs, motor imagery training given with traditional methods or virtual reality systems for the purpose of improving balance and postural control. There are studies showing the effectiveness of many methods in geriatric individuals. However, no study has been found that examines and compares the effects of virtual reality-based balance training and motor imagery training combined with action observation in addition to virtual reality-based balance training in geriatric individuals. For this reason, this study 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 study, which was designed as a prospective, randomized controlled, cross-sectional, single-blind (evaluator), will include 46 geriatric individuals aged 60 and over. The study will be initiated with individuals who meet the inclusion/exclusion criteria of the study. 46 geriatric individuals will be randomized into 2 groups. The study group (23 cases) will be given motor imagery training and virtual reality-based balance training along with action observation. Only virtual reality-based balance training will be given to the control group (23 cases). First of all, age, gender, height, body weight, upper extremity dominant side, lower extremity dominant side, body mass index, smoking history, alcohol consumption, occupation, employment status, chronic diseases, regularly used drugs, history of falling and staggering, history and pedigree information, independence in daily living activities, ability to walk 10 meters without any walking aid will be recorded. In the first evaluation before the training, the measurement of the electrical potential changes known as muscle motor unit action potentials of the subjects during the postural swings will be evaluated with the electromyography biofeedback device. Static and dynamic balance assessments will be evaluated with computerized kinesthetic balance device, Berg Balance Scale and 10 Meter Walk Test. Three-axis (x, y and z) evaluation of body oscillations will be made with an android-based smartphone application. Motor imagery skills will be evaluated with the Movement Imagination Questionnaire-3 (HIA-3) and the mental stopwatch test. All assessments will be repeated before and after the training (6 weeks later) by a researcher blinded to the training. As a training protocol, individuals in both groups 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. Before the balance training, a 5-minute relaxation training will be given to both groups. In addition to the virtual reality-based balance and relaxation training, the study group will be given motor imagery training (10 min + 10 min) with action observation before the balance training. The trainings will be applied 2 days a week for 6 weeks. Each training session; 25 min for the control group. (Relaxation training (5 min) + virtual reality-based balance training (20 min), 45 min for the study group. (Relaxation training (5 min) + motor imagery training (20 min) + virtual reality-based balance training (20 min) with action observation. All questionnaires, scales, tests and devices used in the initial evaluations will be repeated for the individuals in both groups at the end of the 6-week training. The effectiveness of the trainings will be compared with appropriate statistical methods within and between groups and discussed in the light of the literature.


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date June 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria: 1. To be between 60-80 years old 2. Having the ability to speak, read, understand and write Turkish 3. 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) 4. Being able to do activities of daily living independently 5. Being able to walk independently (without using a walking aid and at least 10 meters) 6. Having a body mass index of <35 kg/m2 (not being severely obese or morbidly obese) Exclusion Criteria: 1. Having visual, hearing and sensory impairment 2. To have had a trauma, lesion or surgery that may affect balance and musculoskeletal system in the last 6 months 3. Having a history of 2 = falls in the last 6 months 4. Having any chronic lower extremity pain 5. Having an acute or chronic illness that may cause problems with balance and falling 6. Being diagnosed with sensory, vestibular and cerebellar ataxia 7. Being on any medication that may cause problems with balance, focus, attention and falling. 8. Exercising regularly, which may affect performance results 9. To stop participating in the study for any reason

Study Design


Intervention

Other:
Balance Training
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.
Motor Imagery 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).
Action Observation 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).

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Mentese Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
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