Intellectual Disability, MildNCT06943196
Effects of Structured Physical Activity Breaks and Free Play in Children With Mild Intellectual Disability
A study testing Structured physical activity break in people with Intellectual Disability, Mild, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability, Mild
- What is being tested?
- Structured physical activity break
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 1 Oct 2025
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Intellectual Disability, Mild
- Being tested
- Structured physical activity break
- Keywords
- Endurance, Behavior, Neurodevelopmental disorder
- Medical subject headings
- Intellectual Disability, Lymphoma, Follicular, Behavior, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured physical activity breakOther
The structured physical activity breaks in classroom will include 5-30 minutes physical activities sequenced as: Week 1,4,7: 5-mintue stretch break, 5-minute marching in place, 30-sec jumping an invisible rope, 30-sec Flap arms like a bird, 5-minute mirror each other's actions and guess, 5-minute hop on one foot/ jump on both feet, draw on board, guess the color, make a circle and play a game of throw a ball in class. Week 2,5,8: 5-minute stretch break, 2-3 laps throughout the classroom, jumping in and out a circle on command, rock-paper-scissors-jump, paint or sketch on book, guess the animal, up-down-stop-go opposites, make a circle and play a game of throw a ball and clap in class.
Week 3,6: 5-minute stretch break, 30-sec balance on one foot, 30-sec hopping, 5-jumping jacks, 5-claps turn around and guess the shape, play a game on board or notebook, make a circle and play a game of throw a ball and jump in class.
| Study group | Role | What they receive |
|---|---|---|
| Structured physical activity break | Experimental | The structured physical activity breaks in classroom will include 5-30 minutes physical activities sequenced as: Week 1,4,7: 5-mintue stretch break, 5-minute marching in place, 30-sec jumping an invisible rope, 30-sec Flap arms like a bird, 5-minute mirror each other's actions and guess, 5-minute hop on one foot/ jump on both feet, draw on board, guess the color, make a circle and play a game of throw a ball in class. Week 2,5,8: 5-minute stretch break, 2-3 laps throughout the classroom, jumping in and out a circle on command, rock-paper-scissors-jump, paint or sketch on book, guess the animal, up-down-stop-go opposites, make a circle and play a game of throw a ball and clap in class.
Week 3,6: 5-minute stretch break, 30-sec balance on one foot, 30-sec hopping, 5-jumping jacks, 5-claps turn around and guess the shape, play a game on board or notebook, make a circle and play a game of throw a ball and jump in class. Receives: Other: Structured physical activity break |
| Free play | No intervention | Free play in classroom will be the activity stations available in the institute. Classroom will be divided into various zones, offering the widest selection of areas for the children to explore. Each zone will have age-appropriate play stations designed to engage the children in diverse activities. In addition to all of the locations, a reserve spots in the classroom will be made so that the students can show their work. This comprises the artwork and crafts that kids will have created in the free play classroom. Free Play is children's self-organized activity. Therapist will observe children in a creative, stimulating play environment and participation in the play. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TGMD-2 for Gross Motor Skills
"TGMD-2" is a tool for gross motor skills evaluation (30) and physical activity (31) in school age children. It comprises of two subtest categories locomotion to measure ability of child to move from one place to another, object control subtest measure the ability of child to perform object manipulation and visual-motor skills. The locomotor subtest has a maximum score of 48 (6 skills × 4 criteria x 2 trials), as does the object control subtest.
The overall TGMD score is the sum of the two subgroups and it ranges from 0 to 96, with higher scores signifying better performance. To calculate the child's percentile rank and standard score, compare the total scores to the normative data in the TGMD-2 manual.
Measured: 8-weeks.
6MWT for endurance
"6-minute walk test" is a tool for measuring functional endurance and physical fitness. Six minute walk test (6MWT) is a field exercise test widely used in clinical practice both in adults and in pediatric patients. Anthropometric characteristics are measured before the test and, peripheral oxygen saturation (SpO2), heart and respiratory rate are measured before and after a 6-minute walk test
Measured: 8-weeks
Strengths and Difficulties Questionnaire for behavior
"Strengths and Difficulties" Parent and Teacher reported questionnaire for children aged 04-17 years is a behavioral measuring tool. The SDQ includes 25 items that examine a range of 'strengths and difficulties' as behavioral indicators of probable mental health disorders. The items contribute to 5 subscales, each with 5 items and a minimum score ranging from 0 (lowest score) to 10 (highest score): conduct difficulties, hyperactivity/inattention, emotional signs, problems with peers, and social conduct. The sum of the first 4 subscales, a total difficulty score that ranges from 0 to 40 (40).
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start17 Apr 2025
- Primary completion17 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disability, MildStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Amjad, MSPT(Peads), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943196
- Sponsor's protocol ID
- REC/RCR/AHS/24/0739
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06943196
- Acronym / sponsor ID
- REC/RCR/AHS/24/0739
- Conditions
- Intellectual Disability, Mild
- Keywords
- Endurance, Behavior, Neurodevelopmental disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 24 Apr 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured physical activity break | Experimental | Other: Structured physical activity breakThe structured physical activity breaks in classroom will include 5-30 minutes physical activities sequenced as: Week 1,4,7: 5-mintue stretch break, 5-minute marching in place, 30-sec jumping an invisible rope, 30-sec Flap arms like a bird, 5-minute mirror each other's actions and guess, 5-minute hop on one foot/ jump on both feet, draw on board, guess the color, make a circle and play a game of throw a ball in class. Week 2,5,8: 5-minute stretch break, 2-3 laps throughout the classroom, jumping in and out a circle on command, rock-paper-scissors-jump, paint or sketch on book, guess the animal, up-down-stop-go opposites, make a circle and play a game of throw a ball and clap in class. Week 3,6: 5-minute stretch break, 30-sec balance on one foot, 30-sec hopping, 5-jumping jacks, 5-claps turn around and guess the shape, play a game on board or notebook, make a circle and play a game of throw a ball and jump in class. |
| Free play | No intervention | –Free play in classroom will be the activity stations available in the institute. Classroom will be divided into various zones, offering the widest selection of areas for the children to explore. Each zone will have age-appropriate play stations designed to engage the children in diverse activities. In addition to all of the locations, a reserve spots in the classroom will be made so that the students can show their work. This comprises the artwork and crafts that kids will have created in the free play classroom. Free Play is children's self-organized activity. Therapist will observe children in a creative, stimulating play environment and participation in the play. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Structured physical activity breakThe structured physical activity breaks in classroom will include 5-30 minutes physical activities sequenced as: Week 1,4,7: 5-mintue stretch break, 5-minute marching in place, 30-sec jumping an invisible rope, 30-sec Flap arms like a bird, 5-minute mirror each other's actions and guess, 5-minute hop on one foot/ jump on both feet, draw on board, guess the color, make a circle and play a game of throw a ball in class. Week 2,5,8: 5-minute stretch break, 2-3 laps throughout the classroom, jumping in and out a circle on command, rock-paper-scissors-jump, paint or sketch on book, guess the animal, up-down-stop-go opposites, make a circle and play a game of throw a ball and clap in class. Week 3,6: 5-minute stretch break, 30-sec balance on one foot, 30-sec hopping, 5-jumping jacks, 5-claps turn around and guess the shape, play a game on board or notebook, make a circle and play a game of throw a ball and jump in class. | Other | Structured physical activity break |
Primary outcome
TGMD-2 for Gross Motor Skills
Time frame: 8-weeks.
"TGMD-2" is a tool for gross motor skills evaluation (30) and physical activity (31) in school age children. It comprises of two subtest categories locomotion to measure ability of child to move from one place to another, object control subtest measure the ability of child to perform object manipulation and visual-motor skills. The locomotor subtest has a maximum score of 48 (6 skills × 4 criteria x 2 trials), as does the object control subtest. The overall TGMD score is the sum of the two subgroups and it ranges from 0 to 96, with higher scores signifying better performance. To calculate the child's percentile rank and standard score, compare the total scores to the normative data in the TGMD-2 manual.
6MWT for endurance
Time frame: 8-weeks
"6-minute walk test" is a tool for measuring functional endurance and physical fitness. Six minute walk test (6MWT) is a field exercise test widely used in clinical practice both in adults and in pediatric patients. Anthropometric characteristics are measured before the test and, peripheral oxygen saturation (SpO2), heart and respiratory rate are measured before and after a 6-minute walk test
Strengths and Difficulties Questionnaire for behavior
Time frame: 8-weeks
"Strengths and Difficulties" Parent and Teacher reported questionnaire for children aged 04-17 years is a behavioral measuring tool. The SDQ includes 25 items that examine a range of 'strengths and difficulties' as behavioral indicators of probable mental health disorders. The items contribute to 5 subscales, each with 5 items and a minimum score ranging from 0 (lowest score) to 10 (highest score): conduct difficulties, hyperactivity/inattention, emotional signs, problems with peers, and social conduct. The sum of the first 4 subscales, a total difficulty score that ranges from 0 to 40 (40).
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 30 Dec 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.
Maria Amjad, MSPT(Peads) principal investigator
Riphah International 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 Structured physical activity break in people with Intellectual Disability, Mild, run by Riphah International University at 1 site in Pakistan.
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 5 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 30 Dec 2025. 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 Pakistan. 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?
TGMD-2 for Gross Motor Skills (time frame: 8-weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.