Skip to main content
Clinical Trials/NCT06506409
NCT06506409
Not yet recruiting
Not Applicable

Effectiveness of Smart-Video Based Game Therapy and Otago-Based Structured Exercises in Women With Osteoporosis

Medipol University1 site in 1 country51 target enrollmentSeptember 1, 2024
ConditionsOsteoporosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Medipol University
Enrollment
51
Locations
1
Primary Endpoint
myometer
Status
Not yet recruiting
Last Updated
last year

Overview

Brief 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.

Detailed Description

Osteoporosis is a musculoskeletal disease characterized by decreased bone mass and deterioration of the microstructure of the bone. The aim of the study is to use smart-based video-based play therapy and Otago-based structured exercises in women with osteoporosis; To evaluate the effect on bone quality, lower extremity muscle strength, balance, fear of falling, kinesiophobia and quality of life. Working Groups Group 1: Smart Based Video Based Game Therapy Group Group 2: Otago Based Structured Exercise Group Group 3: Control Group Participants who agree to participate in the study are first evaluated with the Mental State Assessment - Standardized Mini Mental Test and Game Therapy group with the Simulator Illness Questionnaire and System Usability Scale, and if they meet the participation criteria, our study involves face-to-face interviews and blood and urine samples are routinely performed by the doctor on all patients at their first visit. Bone quality will be evaluated using bone turnover markers. Static balance with Romberg Test, dynamic balance with Four Square Step Test, functionality with Timed Up and Go Test, fear of falling with International Fall Activity Scale, kinesiophobia with Tampa Kinesiophobia Scale, muscle strength with Myometer, quality life with European Osteoporosis Association Quality of Life Questionnaire-41 will be evaluated.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
November 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Yağmur KARAMAN POLAT

Research Assistant

Medipol University

Eligibility Criteria

Inclusion Criteria

  • Women in the climacteric period with osteoporosis between the ages of 45-65
  • Those with DEXA T score \< -2.5 SD,
  • Those who have independent ambulation,
  • Those who have no history of falling in the last year
  • Those with a mini mental test score of 24 and above

Exclusion Criteria

  • Those who have participated in any exercise program in the last 3 months,
  • Those who need support in ambulation,
  • Those with a history of pathological fracture due to significant post-traumatic or malignancy,
  • Those who have any systemic disease that may hinder the practices,
  • Those with vestibular dysfunction,
  • For participants in the smart video-based game therapy group, those who are not suitable to use the system according to the System Usability Scale and Simulator Illness Questionnaire

Outcomes

Primary Outcomes

myometer

Time Frame: eight weeks

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.

Four Square Step Test

Time Frame: eight weeks

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.

Tampa Kinesiophobia Scale

Time Frame: eight weeks

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

blood and urine samples

Time Frame: eight weeks

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).

time up and go test

Time Frame: eight weeks

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.

International Falls Effectiveness Scale

Time Frame: eight weeks

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.

Romberg test

Time Frame: eight weeks

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.

European Osteoporosis Association Quality of Life Questionnaire-41

Time Frame: eight weeks

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.

Secondary Outcomes

  • System Usability Scale(eight weeks)
  • Simulator Sickness Survey(eight weeks)
  • Standardized Mini Mental Test(eight weeks)

Study Sites (1)

Loading locations...

Similar Trials