Effectiveness of Smart-Video Based Game Therapy and Otago-Based Structured Exercises in Women With Osteoporosis
NCT Number: NCT06506409
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoporosis
Interventions: DEVICE: Smart-Video Based Game Therapy|OTHER: Otago Based Structured Exercise|OTHER: No intervention
Sponsor: Medipol University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-11-01
Locations: Ümraniye Eğitim Araştırma Hastanesi, Istanbul, Ümraniye, 34764, Turkey

Summary:
In this project, researchers evaluated the effects and differences of smart-video based game therapy and Otago-based structured exercises in women with osteoporosis; aimed to evaluate their applicability in women with osteoporosis.

Primary Outcome Measures: blood and urine samples, Evaluation will be made with Bone turnover markers in the individuals' blood and urine samples. Bone turnover markers are classified as bone formation and resorption markers. Bone formation markers; serum osteocalcin (OC), serum total alkaline phosphatase (ALP); Bone resorption markers; urine deoxypyridinoline (DPD), free collagen cross-linked N-telopeptide (NTX)., eight weeks|Romberg test, It will be evaluated with the Romberg test. It is desirable to maintain postural control for 20-30 seconds with feet together, eyes open and closed. Additionally, the Romberg test is performed on a soft ground., eight weeks|Four Square Step Test, It will be evaluated with the Four Square Step Test. By placing two canes on a flat surface, 4 squares are created and the squares are numbered. The participant is told that he/she must step into each square in the successive order (1-2-3-4-1-4-3-2-1) as fast as possible, without touching the canes, and that both feet must contact the ground in each square. The time to complete the sequence is recorded as a score. 2 scores are measured and the best one is taken., eight weeks|time up and go test, Evaluation will be made with a time up and go test. A point is marked 3 m away from the chair where the participant is sitting. The participant is asked to get up from the chair, walk 3 m, turn back and sit on the chair again, and the time to complete the test is measured and recorded in seconds., eight weeks|International Falls Effectiveness Scale, It will be evaluated with the International Falls Effectiveness Scale. It is a scale that evaluates how confident elderly individuals are in their daily life activities and shows their level of fear of falling. Each item of the scale, which consists of 16 items, is rated between 1 and 4 points (I am not worried at all: 1 point, I am a little worried: 2 points, I am quite worried: 3 points, I am very worried: 4 points). The total scale score ranges from 16 to 64, with a higher score indicating increased fear of falling., eight weeks|Tampa Kinesiophobia Scale, The Tampa Kinesiophobia Scale developed by Miller, Kori and Todd will be used to evaluate kinesiophobia. It consists of 17 items including parameters of injury, re-injury, fear and avoidance in work-related activities. The scale uses a 4-point system, where 1 point means strongly disagree and 4 points means completely agree. A high score from the scale indicates a high kinesiophobia valu, eight weeks|myometer, The lower extremity muscle strength of all participants will be measured with a myometer. Muscle groups to be evaluated: Gluteus medius, gluteus maximus, adductor, quadriceps femoris, hamstring, gastrocnemius-soleus, tibialis anterior. Each measurement is repeated 3 times and the average of the test is recorded in kilograms., eight weeks|European Osteoporosis Association Quality of Life Questionnaire-41, European Osteoporosis Association Quality of Life Questionnaire-41, such as pain (5 items), physical function (17 items), social activity (7 items), general health assessment (3 items) and mental function (9 items); It consists of 5 subscales examining five dimensions of health. It is scored on a 1-5 Likert type scale. A high score indicates poor quality of life., eight weeks
Secondary Outcome Measures: Standardized Mini Mental Test, Standardized Mini Mental Test (MMSE) will be used to evaluate mental status. MMSE can be used to screen for cognitive impairment, estimate the severity of cognitive impairment at a particular point in time, track the course of cognitive changes in the individual over time, and evaluate the individual's response. It evaluates different cognitive status subheadings such as attention, language, memory, orientation, and visual spatial competence. MMSE is scored between 0-30 and \>24 is interpreted as normal cognitive status., eight weeks|Simulator Sickness Survey, Simulator Sickness Survey; 16 symptoms, such as eye fatigue, nausea, sweating and headache, are evaluated in 4 different severity levels (none, mild, moderate and severe). Symptoms; They are grouped into three categories: nausea, oculomotor disturbance and disorientation. Higher scores in each category indicate stronger disease symptoms., eight weeks|System Usability Scale, It consists of 10 statements that help evaluate the ease of use of websites, software, hardware, mobile devices and other technological applications. The scale, which uses a 5-point Likert scale, is basically a survey created to evaluate usability. The average value is taken as 68, and a score greater than 68 indicates that the system is above average. Products with the highest usability evaluation are in the A+ class and the percentage range is between 96-100., eight weeks