Clinical trial NCT06943196: Effects of Structured Physical Activity Breaks and Free Play in Children With Mild Intellectual Disability
Official title: Effects of Structured Physical Activity Breaks and Free Play in Classroom on Gross Motor Skills, Endurance, and Behavior in Children With Mild Intellectual Disability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability, Mild
Keywords: Endurance
Behavior
Neurodevelopmental disorder
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 22
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with mild intellectual disability (MID) typically exhibit delays in both intellectual and adaptive functioning, with the onset occurring during the developmental period.

These children often learn new information and skills at a slower pace compared to their peers and frequently struggle academically. Structured physical activity breaks (SPAB) in the classroom are short, planned periods of physical exercise integrated into the school day to enhance children's physical fitness and behavioral outcomes. Free play (FP) in which children may choose and engage in activities at their own pace, establishing creativity, social engagement, and self-regulation. Study includes 22 participants and divided into 2 groups, one group receiving (SPAB) and the other group participating in free play (FP). The physical activity breaks, lasting between 5 to 30 minutes. SPAB group will engage in a sequence of activities. These activities will start with a 5-minute stretch, followed by 5 minutes of marching in place, 30 seconds of jumping an invisible rope, 30 seconds of flapping arms like a bird, 5 minutes of mirroring each other's actions and guessing, 5 minutes of hopping on one foot or jumping on both feet, drawing on the board, guessing the color, and making a circle to play a game in class. In comparison, the FP group will have access to various activity stations within the classroom, allowing children to choose their activities within a 30-minute time frame. The intervention will be implemented 5-days a week for a total of 8-weeks. Gross Motor Development-2 (TGMD-2) use for assessing gross motor skills, the 6-minute walk test use for measuring functional capacity of endurance, and the Strengths and Difficulties Questionnaire (SDQ) use for evaluating behavior. Data analysis will be conducted using SPSS version 27.

Detailed description: Children with mild intellectual disability (MID) typically exhibit delays in both intellectual and adaptive functioning, with the onset occurring during the developmental period. These children often learn new information and skills at a slower pace compared to their peers and frequently struggle academically. Structured physical activity breaks (SPAB) in the classroom are short, planned periods of physical exercise integrated into the school day to enhance children's physical fitness and behavioral outcomes. Free play (FP) in which children may choose and engage in activities at their own pace, establishing creativity, social engagement, and self-regulation. Gross motor skills, which include activities such as running, jumping, and balancing, are crucial for the overall physical development of children. Endurance, the ability to sustain physical activity over time often underdeveloped in children with MID. Behavioral outcomes, including social interaction, attention, and self-control, are also influenced by physical activity. This study aims to investigate the comparative effects of implementing SPAB as part of a comprehensive school physical activity program and FP on children with mild intellectual disabilities. Study includes 22 participants and divided into 2 groups, one group receiving (SPAB) and the other group participating in free play (FP). The physical activity breaks, lasting between 5 to 30 minutes. SPAB group will engage in a sequence of activities. These activities will start with a 5-minute stretch, followed by 5 minutes of marching in place, 30 seconds of jumping an invisible rope, 30 seconds of flapping arms like a bird, 5 minutes of mirroring each other's actions and guessing, 5 minutes of hopping on one foot or jumping on both feet, drawing on the board, guessing the color, and making a circle to play a game in class. In comparison, the FP group will have access to various activity stations within the classroom, allowing children to choose their activities within a 30-minute time frame. The intervention will be implemented 5-days a week for a total of 8-weeks. Gross Motor Development-2 (TGMD-2) use for assessing gross motor skills, the 6-minute walk test use for measuring functional capacity of endurance, and the Strengths and Difficulties Questionnaire (SDQ) use for evaluating behavior. Data analysis will be conducted using SPSS version 27.

Eligibility criteria: Inclusion Criteria:

* Mild Intellectual Disability i-e mild deficit in intellectual and adaptive functions, having onset in developmental period (24) approximate IQ range of 50 to 69 (25).
* ADLs are preserved and complex functions minimally impaired (26).
* Attendance of a special educational center;
* A medically cleared status from any physical ailment for participation in the baseline examinations.
* Children are able/ allowed to interact with the environment and use of resources during free play in school/institute

Exclusion Criteria:

* Children with chronic medical conditions/ physical disabilities/balance issues/injuries that prevent participation in physical activity
* Lack of informed consent from parents' and/or legal guardians' for their children's participation;
* Coexisting conditions: autism, Down syndrome, cerebral palsy (CP), any muscular dystrophy, or neurological disorders such as epilepsy or brain damage;
* Children with severe motor disability Comorbidities like oncological, rheumatic, orthopedic or cardiac diseases

Primary outcomes:
measure: TGMD-2 for Gross Motor Skills
timeFrame: 8-weeks.
measure: 6MWT for endurance
timeFrame: 8-weeks
measure: Strengths and Difficulties Questionnaire for behavior
timeFrame: 8-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: PSRD
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maria Amjad, MSPT(Peads)
role: PRINCIPAL_INVESTIGATOR
References: