Intellectual DisabilityNCT06097819
Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities
A study testing Mobile app-based game group, Supervised combined sensor-based game group and Individualized occupational therapy group in people with Intellectual Disability, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Individuals with intellectual disabilities face challenges in areas of attention, motor skills, and awareness. Among the problems they experience are difficulties in focusing, transitioning from one activity to another, performing tasks in sequence in skills such as copying, reading, and writing. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Mobile app-based game group, Supervised combined sensor-based game group and Individualized occupational therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 10 Feb 2024
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-30.
- Having an IQ score between 40-70 as determined by psychiatric evaluation.
- Possessing mild to moderate intellectual disability.
- Being able to participate in games.
Who cannot join
- Presence of behavioral disorders.
- Inability to cooperate with application instructions.
- Individuals with visual problems and sensitivity to light.
- Functional limitations due to neurological, vascular, and cardiac problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bağcılar Municipality Feyzullah Kıyıklık Palace for the Disabled Technotherapy Center
Istanbul, Bagcilar
About this study
Official title: Investigation of the Effect of Occupational Therapy-based Rehabilitative Games on Motor Skills, Proprioception and Cognitive Functions in Individuals With Intellectual Disabilities
Individuals with intellectual disabilities face challenges in areas of attention, motor skills, and awareness. Among the problems they experience are difficulties in focusing, transitioning from one activity to another, performing tasks in sequence in skills such as copying, reading, and writing. Additionally, they tend to form sentences with misarranged words. Generally, they may present with disorganized or weak handwriting. Other reported issues in this population include coordination problems in extremities and balance disturbances. These essential life skills can impede the individual's ability to move safely. With the recent integration of technology into rehabilitation, new intervention and assessment methods have emerged for occupational therapists. Systems like Microsoft Kinect, Nintendo Wii, Xbox, and Leap Motion are being used in these methods. In the literature, Kwok et al. included 73 participants aged between 60-85 in their study. They examined the connection between swinging speeds while standing on both feet on a balance board and the risk of falling. They concluded that the anterior-posterior swing speed measure derived from the Wii Balance Board (WBB) could complement current clinic-based measurements in predicting future falls among community-dwelling older adults. Reviewing the literature, technological rehabilitation applications are observed to be used in various patient groups. However, studies on occupational therapy-based technological rehabilitation interventions in individuals with intellectual disabilities are limited. To our knowledge, there isn't a study evaluating awareness, cognitive, and physical skills in intellectually disabled individuals using Leapmotion, Xbox, Balanceboard sensors, and mobile games. Based on this information, the aim of our study is to investigate the effects of occupational therapy-based rehabilitative games on motor skills, proprioception, and cognitive functions in individuals with intellectual disabilities.
Read the detailed description
A total of 45 participants will be included in the study. These 45 participants will be divided into three groups, and each participant will receive an intervention twice a week for six weeks following the initial assessment.
Group → Mobile application-based game group Group → Supervised combined sensor-based game group Group → Individualized occupational therapy group Participants will be assessed both before and after the 12-session intervention. Participants' attention and reaction time will be evaluated using MOXO-dCPT, proprioceptive awareness will be assessed using Becure Extremity ROM, neuromuscular function will be measured using the 30-second sit-to-stand test, and fine motor skills will be assessed using the nine-hole peg test.
Inclusion criteria:
- Being aged between 18 and 30.
- Obtaining an IQ score between 40 and 70 based on the psychiatric evaluation.
- Having mild to moderate intellectual disability.
- Being able to participate in the games.
Exclusion criteria:
- Presence of behavioral disorders.
- Inability to cooperate with the application instructions.
- Individuals with visual problems and sensitivity to light.
- Presence of limiting neurological, vascular, and cardiac problems.
Outcome measures:
Joint position sense: Joint position sense evaluation measures proprioceptive awareness. Individuals are asked to actively reposition to a degree shown to them before the measurement begins. The individual's active repositioning angle is then measured again, and the difference between the required angle and the actual angle is compared. The closer these two values are to each other, the better the individual's proprioceptive awareness. In our study, proprioceptive awareness for shoulder abduction and flexion measurements will be assessed using the Becure Extremity Rom.
Evaluation of Neuromuscular Function
The 30-second sit-to-stand test requires participants to sit down and stand up from a chair as many times as possible within a 30-second time frame. The scores are associated with muscle strength and functionality. This test is a rapid, cost-effective, safe, and commonly used clinical assessment for lower extremity function.
Evaluation of Fine Motor Skills
The Nine Hole Peg Test consists of a platform with nine holes spaced 32mm apart and nine pegs. Individuals are instructed to remove all pegs from the holes as quickly as possible, one by one, and then to pick up each peg and place it back into the holes on the platform in the shortest time possible. The platform is positioned toward the hand being tested, while the pegs are placed towards the individual's midline. Only the evaluated hand performs the test, and the non-evaluated hand is allowed to hold the edge of the platform for stability. Scores are based on the time, recorded in seconds, taken to complete the test activity. Evaluation of Attention and Reaction Time
The MOXO-dCPT is a computer-based test anchored on an online platform comprising eight sections. The auditory and visual distractors present in the test simulate environmental conditions individuals encounter in daily life. Each section contains 53 stimuli. Every stimulus is displayed in the center of the computer screen as either a target or non-target. This is followed by an interval of equal duration where no stimuli are shown, referred to as a "gap". Participants are instructed to press the space bar in response to targets and refrain from pressing it for non-targets. This is done while overlooking a series of visual and auditory distractors (e.g., an animation of a barking dog). The sections of the MOXO-dCPT vary in cognitive challenge. Within the eight sections of this test; the 1st and 8th sections include classic distractors, the 2nd and 3rd sections involve visual distractors, the 4th and 5th sections contain auditory distractors, and the 6th and 7th sections feature combinations of both visual and auditory distractors.
- Conditions
- Intellectual Disability
- Being tested
- Mobile app-based game group, Supervised combined sensor-based game group, Individualized occupational therapy group
- Keywords
- exergame, Intellectual Disability, Video game based therapy
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app-based game groupOther
Mobile app based game therapy+Occupational therapy+Sensor-based game therapy
Supervised combined sensor-based game groupOther
Occupational therapy+Sensor-based game therapy
Individualized occupational therapy groupOther
Occupational therapy
| Study group | Role | What they receive |
|---|---|---|
| Mobile app-based game group | Experimental | The mobile app-based game group will receive the Becure mobile game program in addition to occupational therapy interventions and the sensor-based game application. This program will be implemented for 10 minutes a day, 5 days a week, for a duration of 6 weeks. Receives: Other: Mobile app-based game group |
| Supervised combined sensor-based game group | Experimental | A supervised combined sensor-based game intervention based on occupational therapy will be applied to this group. For this group, a supervised combined sensor-based game program was designed in addition to 12 sessions of occupational therapy interventions over 6 weeks, with 2 sessions per week and each session averaging 30 minutes Receives: Other: Supervised combined sensor-based game group |
| Individualized occupational therapy group | Experimental | Individualized occupational therapy group will receive occupational therapy sessions. During these sessions, activities that involve weight transfer, balance, fine motor skills, neuromuscular function, and cognitive skills will be implemented. Treatment will be administered for 2 days a week over a period of 6 weeks. Each session will last an average of 30 minutes. A total of 12 occupational therapy sessions will be conducted Receives: Other: Individualized occupational therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint position sense
Individuals are asked to actively reposition to a degree shown to them before the measurement begins. The individual's active repositioning angle is then measured again, and the difference between the required angle and the actual angle is compared. The closer these two values are to each other, the better the individual's proprioceptive awareness. In our study, proprioceptive awareness for shoulder abduction and flexion measurements will be assessed using the Becure Extremity Rom.
Measured: 10 minutes
Neuromuscular Function
The 30-second sit-to-stand test requires participants to sit down and stand up from a chair as many times as possible within a 30-second time frame. The scores are associated with muscle strength and functionality. This test is a rapid, cost-effective, safe, and commonly used clinical assessment for lower extremity function.
Measured: 10 minutes
Evaluation of Fine Motor Skills
The Nine Hole Peg Test consists of a platform with nine holes spaced 32mm apart and nine pegs. Individuals are instructed to remove all pegs from the holes as quickly as possible, one by one, and then to pick up each peg and place it back into the holes on the platform in the shortest time possible. The platform is positioned toward the hand being tested, while the pegs are placed towards the individual's midline. Only the evaluated hand performs the test, and the non-evaluated hand is allowed to hold the edge of the platform for stability. Scores are based on the time, recorded in seconds, taken to complete the test activity.
Measured: 15 minutes
Attention and Reaction Time
MOXO-dCPT
The MOXO-dCPT is a computer-based test anchored on an online platform comprising eight sections. The auditory and visual distractors present in the test simulate environmental conditions individuals encounter in daily life.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Sep 2023
- Primary completion5 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burak menek, Istanbul Medipol University Hospital
- Investigators
- Burak Menek, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097819
- Sponsor's protocol ID
- E-10840098-772.02-212
- Status last verified
- Feb 2024
- First submitted
- 19 Oct 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diril E, Menek B, Emir A, Tarakci D, Tarakci E. The Effect of a Video-Based Game Exercise Program on Motor Skills, Proprioception, and Cognitive Functions in Individuals With Intellectual Disabilities. Occup Ther Int. 2025 Jan 30;2025:8410494. doi: 10.1155/oti/8410494. eCollection 2025.
PubMed 39949506
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Occupational Therapy-based Rehabilitative Games on Motor Skills, Proprioception and Cognitive Functions in Individuals With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT06097819
- Acronym / sponsor ID
- E-10840098-772.02-212
- Conditions
- Intellectual Disability
- Keywords
- exergame, Intellectual Disability, Video game based therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 24 Oct 2023 (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.
Individuals with intellectual disabilities face challenges in areas of attention, motor skills, and awareness. Among the problems they experience are difficulties in focusing, transitioning from one activity to another, performing tasks in sequence in skills such as copying, reading, and writing. Additionally, they tend to form sentences with misarranged words. Generally, they may present with disorganized or weak handwriting. Other reported issues in this population include coordination problems in extremities and balance disturbances. These essential life skills can impede the individual's ability to move safely. With the recent integration of technology into rehabilitation, new intervention and assessment methods have emerged for occupational therapists. Systems like Microsoft Kinect, Nintendo Wii, Xbox, and Leap Motion are being used in these methods. In the literature, Kwok et al. included 73 participants aged between 60-85 in their study. They examined the connection between swinging speeds while standing on both feet on a balance board and the risk of falling. They concluded that the anterior-posterior swing speed measure derived from the Wii Balance Board (WBB) could complement current clinic-based measurements in predicting future falls among community-dwelling older adults. Reviewing the literature, technological rehabilitation applications are observed to be used in various patient groups. However, studies on occupational therapy-based technological rehabilitation interventions in individuals with intellectual disabilities are limited. To our knowledge, there isn't a study evaluating awareness, cognitive, and physical skills in intellectually disabled individuals using Leapmotion, Xbox, Balanceboard sensors, and mobile games. Based on this information, the aim of our study is to investigate the effects of occupational therapy-based rehabilitative games on motor skills, proprioception, and cognitive functions in individuals with intellectual disabilities.
Detailed description
A total of 45 participants will be included in the study. These 45 participants will be divided into three groups, and each participant will receive an intervention twice a week for six weeks following the initial assessment.
Group → Mobile application-based game group Group → Supervised combined sensor-based game group Group → Individualized occupational therapy group Participants will be assessed both before and after the 12-session intervention. Participants' attention and reaction time will be evaluated using MOXO-dCPT, proprioceptive awareness will be assessed using Becure Extremity ROM, neuromuscular function will be measured using the 30-second sit-to-stand test, and fine motor skills will be assessed using the nine-hole peg test.
Inclusion criteria:
- Being aged between 18 and 30.
- Obtaining an IQ score between 40 and 70 based on the psychiatric evaluation.
- Having mild to moderate intellectual disability.
- Being able to participate in the games.
Exclusion criteria:
- Presence of behavioral disorders.
- Inability to cooperate with the application instructions.
- Individuals with visual problems and sensitivity to light.
- Presence of limiting neurological, vascular, and cardiac problems.
Outcome measures:
Joint position sense: Joint position sense evaluation measures proprioceptive awareness. Individuals are asked to actively reposition to a degree shown to them before the measurement begins. The individual's active repositioning angle is then measured again, and the difference between the required angle and the actual angle is compared. The closer these two values are to each other, the better the individual's proprioceptive awareness. In our study, proprioceptive awareness for shoulder abduction and flexion measurements will be assessed using the Becure Extremity Rom.
Evaluation of Neuromuscular Function
The 30-second sit-to-stand test requires participants to sit down and stand up from a chair as many times as possible within a 30-second time frame. The scores are associated with muscle strength and functionality. This test is a rapid, cost-effective, safe, and commonly used clinical assessment for lower extremity function.
Evaluation of Fine Motor Skills
The Nine Hole Peg Test consists of a platform with nine holes spaced 32mm apart and nine pegs. Individuals are instructed to remove all pegs from the holes as quickly as possible, one by one, and then to pick up each peg and place it back into the holes on the platform in the shortest time possible. The platform is positioned toward the hand being tested, while the pegs are placed towards the individual's midline. Only the evaluated hand performs the test, and the non-evaluated hand is allowed to hold the edge of the platform for stability. Scores are based on the time, recorded in seconds, taken to complete the test activity. Evaluation of Attention and Reaction Time
The MOXO-dCPT is a computer-based test anchored on an online platform comprising eight sections. The auditory and visual distractors present in the test simulate environmental conditions individuals encounter in daily life. Each section contains 53 stimuli. Every stimulus is displayed in the center of the computer screen as either a target or non-target. This is followed by an interval of equal duration where no stimuli are shown, referred to as a "gap". Participants are instructed to press the space bar in response to targets and refrain from pressing it for non-targets. This is done while overlooking a series of visual and auditory distractors (e.g., an animation of a barking dog). The sections of the MOXO-dCPT vary in cognitive challenge. Within the eight sections of this test; the 1st and 8th sections include classic distractors, the 2nd and 3rd sections involve visual distractors, the 4th and 5th sections contain auditory distractors, and the 6th and 7th sections feature combinations of both visual and auditory distractors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile app-based game group | Experimental | Other: Mobile app-based game groupThe mobile app-based game group will receive the Becure mobile game program in addition to occupational therapy interventions and the sensor-based game application. This program will be implemented for 10 minutes a day, 5 days a week, for a duration of 6 weeks. |
| Supervised combined sensor-based game group | Experimental | Other: Supervised combined sensor-based game groupA supervised combined sensor-based game intervention based on occupational therapy will be applied to this group. For this group, a supervised combined sensor-based game program was designed in addition to 12 sessions of occupational therapy interventions over 6 weeks, with 2 sessions per week and each session averaging 30 minutes |
| Individualized occupational therapy group | Experimental | Other: Individualized occupational therapy groupIndividualized occupational therapy group will receive occupational therapy sessions. During these sessions, activities that involve weight transfer, balance, fine motor skills, neuromuscular function, and cognitive skills will be implemented. Treatment will be administered for 2 days a week over a period of 6 weeks. Each session will last an average of 30 minutes. A total of 12 occupational therapy sessions will be conducted |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-30.
- Having an IQ score between 40-70 as determined by psychiatric evaluation.
- Possessing mild to moderate intellectual disability.
- Being able to participate in games.
Key exclusion criteria (4 listed)
- Presence of behavioral disorders.
- Inability to cooperate with application instructions.
- Individuals with visual problems and sensitivity to light.
- Functional limitations due to neurological, vascular, and cardiac problems.
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 |
|---|---|---|
| Mobile app-based game groupMobile app based game therapy+Occupational therapy+Sensor-based game therapy | Other | Mobile app-based game group |
| Supervised combined sensor-based game groupOccupational therapy+Sensor-based game therapy | Other | Supervised combined sensor-based game group |
| Individualized occupational therapy groupOccupational therapy | Other | Individualized occupational therapy group |
Primary outcome
Joint position sense
Time frame: 10 minutes
Individuals are asked to actively reposition to a degree shown to them before the measurement begins. The individual's active repositioning angle is then measured again, and the difference between the required angle and the actual angle is compared. The closer these two values are to each other, the better the individual's proprioceptive awareness. In our study, proprioceptive awareness for shoulder abduction and flexion measurements will be assessed using the Becure Extremity Rom.
Neuromuscular Function
Time frame: 10 minutes
The 30-second sit-to-stand test requires participants to sit down and stand up from a chair as many times as possible within a 30-second time frame. The scores are associated with muscle strength and functionality. This test is a rapid, cost-effective, safe, and commonly used clinical assessment for lower extremity function.
Evaluation of Fine Motor Skills
Time frame: 15 minutes
The Nine Hole Peg Test consists of a platform with nine holes spaced 32mm apart and nine pegs. Individuals are instructed to remove all pegs from the holes as quickly as possible, one by one, and then to pick up each peg and place it back into the holes on the platform in the shortest time possible. The platform is positioned toward the hand being tested, while the pegs are placed towards the individual's midline. Only the evaluated hand performs the test, and the non-evaluated hand is allowed to hold the edge of the platform for stability. Scores are based on the time, recorded in seconds, taken to complete the test activity.
Attention and Reaction Time
Time frame: 20 minutes
MOXO-dCPT The MOXO-dCPT is a computer-based test anchored on an online platform comprising eight sections. The auditory and visual distractors present in the test simulate environmental conditions individuals encounter in daily life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39949506Diril E, Menek B, Emir A, Tarakci D, Tarakci E. The Effect of a Video-Based Game Exercise Program on Motor Skills, Proprioception, and Cognitive Functions in Individuals With Intellectual Disabilities. Occup Ther Int. 2025 Jan 30;2025:8410494. doi: 10.1155/oti/8410494. eCollection 2025.
- 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.
Burak Menek, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app-based game group, Supervised combined sensor-based game group and Individualized occupational therapy group in people with Intellectual Disability, run by Istanbul Medipol University Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 20 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position sense (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06097819, which also lists 1 linked publication.
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 20 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.