- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06097819
Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities
Investigation of the Effect of Occupational Therapy-based Rehabilitative Games on Motor Skills, Proprioception and Cognitive Functions in Individuals With Intellectual Disabilities
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burak Menek, PhD
- Phone Number: 05444761640
- Email: bmenek@medipol.edu.tr
Study Contact Backup
- Name: Elif Diril
- Email: elifdiril1@gmail.com
Study Locations
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey
- Bağcılar Municipality Feyzullah Kıyıklık Palace for the Disabled Technotherapy Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile app-based game group
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.
|
Mobile app based game therapy+Occupational therapy+Sensor-based game therapy
|
Experimental: Supervised combined sensor-based game group
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
|
Occupational therapy+Sensor-based game therapy
|
Experimental: Individualized occupational therapy group
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
|
Occupational therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
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.
|
10 minutes
|
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.
|
15 minutes
|
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. |
20 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Burak Menek, PhD, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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