OsteoporosisNCT06506409
Effectiveness of Smart-Video Based Game Therapy and Otago-Based Structured Exercises in Women With Osteoporosis
A study testing Smart-Video Based Game Therapy and Otago Based Structured Exercise in people with Osteoporosis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Smart-Video Based Game Therapy and Otago Based Structured Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ümraniye Eğitim Araştırma Hastanesi
Istanbul, Ümraniye, 34764
Yağmur KARAMAN POLAT, Research assistant, +905458718527, ykaraman@medipol.edu.tr
Gülay ARAS BAYRAM, Associate professor, +905054966284, garas@medipol.edu.tr
About this study
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Smart-Video Based Game Therapy, Otago Based Structured Exercise, No intervention
- Keywords
- game therapy, rehabilitative game, otago exercise
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart-Video Based Game TherapyDevice
The Active Arcade program will be practiced 2 days a week for 8 weeks. Individuals in this group will be given a 1-minute rest break between games. Sessions will be approximately 30 minutes. Selected games focus on balance, coordination and weight transfer.
Otago Based Structured ExerciseOther
Exercises will be done 2 days a week for 8 weeks and last approximately 30 minutes. In general, if individuals can perform 2 sets of 10 repetitions at a difficulty level with quality, they can move on to a higher difficulty level. It consists of warm-up, balance and strengthening exercises. It was developed to increase balance.
No interventionOther
A training presentation based on the guidelines and individuals' needs will be developed for participants in the control group. The presentation will include an infographic developed with the CANVA program, a test created with Google Forms, and a summary video developed with the Powtoon program. The created presentation will be presented online to individuals in the control group, and the participants will be followed by phone once a week for 8 weeks. The topics of the training will be: What is Osteoporosis, Osteoporosis Prevalence, Findings and Risk Factors, Diagnosis of Osteoporosis, Osteoporosis Prevention and Nutrition, Osteoporosis and Exercise, Preventing Falls.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Smart-Video Based Game Therapy Group | Active comparator | The Active Arcade program will be practiced 2 days a week for 8 weeks. Individuals in this group will be given a 1-minute rest break between games. Sessions will be approximately 30 minutes. The selected games focus on balance, coordination and weight transfer. Receives: Device: Smart-Video Based Game Therapy |
| Otago Based Structured Exercise Group | Active comparator | Exercises will be done 2 days a week for 8 weeks and last approximately 30 minutes. In general, if individuals can perform 2 sets of 10 repetitions of movements at a difficulty level with quality, they can move on to a higher difficulty level. It consists of warm-up, balance and strengthening exercises. It was developed to increase balance. Receives: Other: Otago Based Structured Exercise |
| Control group | Active comparator | A training presentation based on the guidelines and individuals' needs will be developed for participants in the control group. The presentation will include an infographic developed with the CANVA program, a test created with Google Forms, and a summary video developed with the Powtoon program. The created presentation will be presented online to individuals in the control group, and the participants will be followed by phone once a week for 8 weeks. The topics of the training will be: What is Osteoporosis, Osteoporosis Prevalence, Findings and Risk Factors, Diagnosis of Osteoporosis, Osteoporosis Prevention and Nutrition, Osteoporosis and Exercise, Preventing Falls. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: eight weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We have three parallel groups: Two treatment groups and one control group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur KARAMAN POLAT, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506409
- Sponsor's protocol ID
- MedipolU-FTR-YKP-01
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Smart-Video Based Game Therapy and Otago-Based Structured Exercises in Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT06506409
- Acronym / sponsor ID
- MedipolU-FTR-YKP-01
- Conditions
- Osteoporosis
- Keywords
- game therapy, rehabilitative game, otago exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We have three parallel groups: Two treatment groups and one control group
| Arm | Type | Receives |
|---|---|---|
| Group 1: Smart-Video Based Game Therapy Group | Active comparator | Device: Smart-Video Based Game TherapyThe Active Arcade program will be practiced 2 days a week for 8 weeks. Individuals in this group will be given a 1-minute rest break between games. Sessions will be approximately 30 minutes. The selected games focus on balance, coordination and weight transfer. |
| Otago Based Structured Exercise Group | Active comparator | Other: Otago Based Structured ExerciseExercises will be done 2 days a week for 8 weeks and last approximately 30 minutes. In general, if individuals can perform 2 sets of 10 repetitions of movements at a difficulty level with quality, they can move on to a higher difficulty level. It consists of warm-up, balance and strengthening exercises. It was developed to increase balance. |
| Control group | Active comparator | Other: No interventionA training presentation based on the guidelines and individuals' needs will be developed for participants in the control group. The presentation will include an infographic developed with the CANVA program, a test created with Google Forms, and a summary video developed with the Powtoon program. The created presentation will be presented online to individuals in the control group, and the participants will be followed by phone once a week for 8 weeks. The topics of the training will be: What is Osteoporosis, Osteoporosis Prevalence, Findings and Risk Factors, Diagnosis of Osteoporosis, Osteoporosis Prevention and Nutrition, Osteoporosis and Exercise, Preventing Falls. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart-Video Based Game TherapyThe Active Arcade program will be practiced 2 days a week for 8 weeks. Individuals in this group will be given a 1-minute rest break between games. Sessions will be approximately 30 minutes. Selected games focus on balance, coordination and weight transfer. | Device | Group 1: Smart-Video Based Game Therapy Group |
| Otago Based Structured ExerciseExercises will be done 2 days a week for 8 weeks and last approximately 30 minutes. In general, if individuals can perform 2 sets of 10 repetitions at a difficulty level with quality, they can move on to a higher difficulty level. It consists of warm-up, balance and strengthening exercises. It was developed to increase balance. | Other | Otago Based Structured Exercise Group |
| No interventionA training presentation based on the guidelines and individuals' needs will be developed for participants in the control group. The presentation will include an infographic developed with the CANVA program, a test created with Google Forms, and a summary video developed with the Powtoon program. The created presentation will be presented online to individuals in the control group, and the participants will be followed by phone once a week for 8 weeks. The topics of the training will be: What is Osteoporosis, Osteoporosis Prevalence, Findings and Risk Factors, Diagnosis of Osteoporosis, Osteoporosis Prevention and Nutrition, Osteoporosis and Exercise, Preventing Falls. | Other | Control group |
Primary outcome
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).
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.
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.
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.
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
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.
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.
3 secondary outcomes
Standardized Mini Mental Test
Time frame: eight weeks
Simulator Sickness Survey
Time frame: eight weeks
System Usability Scale
Time frame: eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart-Video Based Game Therapy and Otago Based Structured Exercise in people with Osteoporosis, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yağmur KARAMAN POLAT, Research assistant (+905458718527, ykaraman@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood and urine samples (time frame: eight weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.