search
Back to results

Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities

Primary Purpose

Intellectual Disability

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobile app-based game group
Supervised combined sensor-based game group
Individualized occupational therapy group
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability focused on measuring exergame, Intellectual Disability, Video game based therapy

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bağcılar Municipality Feyzullah Kıyıklık Palace for the Disabled Technotherapy CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mobile app-based game group

Supervised combined sensor-based game group

Individualized occupational therapy group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Istanbul Medipol University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06097819
Brief Title
Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities
Official Title
Investigation of the Effect of Occupational Therapy-based Rehabilitative Games on Motor Skills, Proprioception and Cognitive Functions in Individuals With Intellectual Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
exergame, Intellectual Disability, Video game based therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile app-based game group
Arm Type
Experimental
Arm Description
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.
Arm Title
Supervised combined sensor-based game group
Arm Type
Experimental
Arm Description
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
Arm Title
Individualized occupational therapy group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Mobile app-based game group
Intervention Description
Mobile app based game therapy+Occupational therapy+Sensor-based game therapy
Intervention Type
Other
Intervention Name(s)
Supervised combined sensor-based game group
Intervention Description
Occupational therapy+Sensor-based game therapy
Intervention Type
Other
Intervention Name(s)
Individualized occupational therapy group
Intervention Description
Occupational therapy
Primary Outcome Measure Information:
Title
Joint position sense
Description
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.
Time Frame
10 minutes
Title
Neuromuscular Function
Description
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.
Time Frame
10 minutes
Title
Evaluation of Fine Motor Skills
Description
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.
Time Frame
15 minutes
Title
Attention and Reaction Time
Description
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.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burak Menek, PhD
Phone
05444761640
Email
bmenek@medipol.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Diril
Email
elifdiril1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burak Menek, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bağcılar Municipality Feyzullah Kıyıklık Palace for the Disabled Technotherapy Center
City
Istanbul
State/Province
Bagcilar
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BURAK MENEK, PhD
Phone
+905444761640
Email
bmenek@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities

We'll reach out to this number within 24 hrs