Clinical trial NCT06506409: Effectiveness of Smart-Video Based Game Therapy and Otago-Based Structured Exercises in Women With Osteoporosis
Official title: Effectiveness of Smart-Video Based Game Therapy and Otago-Based Structured Exercises in Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoporosis
Keywords: game therapy
rehabilitative game
otago exercise
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 51
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We have three parallel groups: Two treatment groups and one control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: blood and urine samples
timeFrame: eight weeks
measure: Romberg test
timeFrame: eight weeks
measure: Four Square Step Test
timeFrame: eight weeks
measure: time up and go test
timeFrame: eight weeks
measure: International Falls Effectiveness Scale
timeFrame: eight weeks
measure: Tampa Kinesiophobia Scale
timeFrame: eight weeks
measure: myometer
timeFrame: eight weeks
measure: European Osteoporosis Association Quality of Life Questionnaire-41
timeFrame: eight weeks
Secondary outcomes:
measure: Standardized Mini Mental Test
timeFrame: eight weeks
measure: Simulator Sickness Survey
timeFrame: eight weeks
measure: System Usability Scale
timeFrame: eight weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ümraniye Eğitim Araştırma Hastanesi
state: Ümraniye
Study officials:
References: