NCT06097819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

October 19, 2023

Last Update Submit

February 19, 2024

Conditions

Keywords

exergameIntellectual DisabilityVideo game based therapy

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    20 minutes

Study Arms (3)

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.

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

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

Other: Individualized occupational therapy group

Interventions

Mobile app based game therapy+Occupational therapy+Sensor-based game therapy

Mobile app-based game group

Occupational therapy+Sensor-based game therapy

Supervised combined sensor-based game group

Occupational therapy

Individualized occupational therapy group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bağcılar Municipality Feyzullah Kıyıklık Palace for the Disabled Technotherapy Center

Istanbul, Bagcilar, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Burak Menek, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 24, 2023

Study Start

September 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 10, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations