Mild Intellectual DisabilityNCT06987188
Effects of Modified Pilates on Improving Trunk Control and Balance in Children With Mild Intellectual Disability
A study testing Modified Pilate Exercises and General Physiotherapy Plan in people with Mild Intellectual Disability, run by Riphah International University at 1 site in Pakistan.
Trial summary
This randomized controlled trial will be conducted at Spectrum Clinic, Lahore, over a duration of 8 weeks to assess the impact of Modified Pilates Exercises on trunk control in children with Intellectual Disability (ID). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Mild Intellectual Disability
- What is being tested?
- Modified Pilate Exercises and General Physiotherapy Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Apr 2025to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 years.
- Diagnosed with mild intellectual disability (IQ 50-70)
- Ability to follow instruction and participate in Pilates Exercises
- No significant physical or neurological conditions that could affect participants
Who cannot join
- Severe intellectual disability(IQ<50)
- Significant physical and neurological conditions (Cerebral palsy, Spinal Cord Injury)
- Visual and Hearing impairments that could impact participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rising Sun Institute
Lahore, Pinjab, 54900
About this study
This randomized controlled trial will be conducted at Spectrum Clinic, Lahore, over a duration of 8 weeks to assess the impact of Modified Pilates Exercises on trunk control in children with Intellectual Disability (ID). ID is characterized by below-average IQ and delays in cognitive and functional development, affecting independence and motor skills. Trunk control plays a crucial role in posture, movement coordination, balance, and daily activities. A total of 40 participants will be selected through non-probability convenience sampling and randomly assigned to two groups: Group A (Modified Pilates Exercises) and Group B (General Physiotherapy Plan). Outcomes will be measured using the Trunk Control Measurement Scale (TCMS) and Pediatric Balance Scale (PBS) at baseline and after 8 weeks. Data will be analyzed using SPSS version 25.
Read the detailed description
Intellectual Disability (ID) is a condition in which individuals experience below-average IQ. Although a variety of terms, including learning disabilities and mental retardation have been used when referring to people who have impairments that impact on their cognitive and adaptive functioning. ID refers to the onset of delayed developmental milestones, which impact on intellectual and functional development, hence independent functioning is likely to be significantly lower than that of the average person during their lifetime. Trunk control can help children with intellectual disabilities meet developmental milestones by helping them to maintain posture, navigate their surroundings, coordinate body part movement, module fine motor control, initiate vestibule oculomotor reflexes, use their hands for various activities, remain seated without falling over and kept their body aligned while walking, running and jumping.
This study will be randomized controlled trial, conducted in Spectrum clinic, Lahore. This study will be completed in time duration of 8 weeks after the approval of synopsis. Non-probability convenience sampling technique will be used and 40 participants will be recruited in this study. Participants will be divided into two groups. Group A (Modified Pilates Exercises) and Group B (General Physiotherapy Plan). Tools will be used are Trunk control measurement (TCMS) and Pediatric Balance Scale (PBS). The data will be recorded at the baseline and after 8th week of intervention. After collection, data will be analyzed by using SPSS version 25.
- Conditions
- Mild Intellectual Disability
- Being tested
- Modified Pilate Exercises, General Physiotherapy Plan
- Keywords
- Mild Intellectual Disability, Trunk control, Balance, Physical therapy, pilate exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Pilate ExercisesOther
Modified Pilates exercises are gentle adaptations of traditional Pilates movements, designed to accommodate various fitness levels, physical limitations, or specific health conditions. These exercises focus on core strength, flexibility, posture, and controlled breathing while reducing strain on joints and muscles. Often recommended for beginners, seniors, or individuals recovering from injury or surgery, modified Pilates may involve the use of props like pillows, resistance bands, or chairs to support proper alignment and ease of movement. By emphasizing slow, mindful motions and personalized adjustments, modified Pilates helps individuals safely build strength, improve mobility, and enhance overall body awareness without the risk of overexertion.
General Physiotherapy PlanOther
A general physiotherapy plan for improving trunk control and balance focuses on enhancing core stability, postural alignment, and coordinated movement through targeted exercises and functional activities. The plan typically begins with gentle activation of deep core muscles such as the transverse abdominis and pelvic floor, progressing to dynamic tasks that challenge balance and coordination, like seated weight shifts, bridging, and reaching tasks in various positions (sitting, kneeling, or standing). Balance training may include exercises on unstable surfaces, gait training, and proprioceptive activities to improve body awareness and stability. The physiotherapy approach is individualized, gradually increasing in complexity and intensity as the patient gains strength and confidence, with consistent emphasis on proper technique, breathing, and safety to support overall mobility and independence.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | : Modified Pilates Exercises, will be given for 8 weeks, 4 times per week. Diaphragmatic Breathing, Bridging and Planks will be given. Intervention Session will be 40-45 minutes with short resting intervals Receives: Other: Modified Pilate Exercises; Other: General Physiotherapy Plan |
| Group B | Experimental | General Physiotherapy plan, Will be given for 8 weeks, 4 times per week. Bottom up Exercises, Bridging and Turning over facilitation. Intervention Session will be 40-45 minutes with short resting intervals Receives: Other: Modified Pilate Exercises; Other: General Physiotherapy Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Scale (TCMS)
The Trunk Control Measurement Scale (TCMS) is a standardized assessment tool used to measure trunk control in individuals with developmental delay, neurological disorders, or motor impairments. It evaluates posture maintenance, trunk stabilization, and movement across six subtasks, each rated on a scale from 0 to 4 or 0 to 5. The total score ranges from 0 to 24, offering a comprehensive evaluation of trunk control ability. The TCMS identifies specific areas of difficulty, tracks progress over time, and directs targeted interventions to enhance trunk control. Administration involves verbal instructions, visual demonstration, or physical guidance from the evaluator, with the participant performing each task up to three times, scored based on the best attempt
Measured: Baseline, 4th week, 8th week
Pediatric Berg Balance Measurement Scale (PBBMS)
The Pediatric Berg Balance Measurement (PBBM) is a well-established tool used to assess balance and postural control in children aged 5-15 years. Developed by Berg and colleagues, it comprises 14 items that evaluate standing, sitting, and transitional movements. Scores on the PBBM range from 0 to 56, with higher scores indicating better balance abilities(20). This assessment typically takes 15-20 minutes to administer and is highly reliable and valid. Physiotherapists, occupational therapists, and researchers utilize the PBBM to evaluate balance impairments in children with developmental delays, injuries, or neurological conditions, and to track progress and intervention outcomes effectively.
Measured: Baseline, 4th week, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start16 Apr 2025
- Primary completion11 Jun 2025 (estimated)
- Study completion11 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Intellectual DisabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be randomized controlled trial, conducted in Mind spark clinic, Lahore. This study will be completed in time duration of 8 weeks after the approval of synopsis. Non-probability convenience sampling technique will be used and 40 participants will be recruited in this study. Participants will be divided into two groups. Group A (Modified Pilates Exercises) and Group B (General Physiotherapy Plan). Tools will be used are Trunk control measurement (TCMS) and Pediatric Balance Scale (PBS). The data will be recorded at the baseline and after 8th week of intervention. After collection, data will be analyzed by using SPSS version 25.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khansa Khizar, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987188
- Sponsor's protocol ID
- REC/RCR/AHS/24/0758
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balayi E, Sedaghati P, Ahmadabadi S. Effects of neuromuscular training on postural control of children with intellectual disability and developmental coordination disorders : Neuromuscular training and postural control. BMC Musculoskelet Disord. 2022 Jul 2;23(1):631. doi: 10.1186/s12891-022-05569-2.
PubMed 35780104
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Pilates on Improving Trunk Control and Balance in Children With Mild Intellectual Disability
- ClinicalTrials.gov ID
- NCT06987188
- Acronym / sponsor ID
- REC/RCR/AHS/24/0758
- Conditions
- Mild Intellectual Disability
- Keywords
- Mild Intellectual Disability, Trunk control, Balance, Physical therapy, pilate exercises
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 11 Jun 2025 (estimated)
- Study completion
- 11 Jun 2025 (estimated)
- First posted
- 23 May 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.
This randomized controlled trial will be conducted at Spectrum Clinic, Lahore, over a duration of 8 weeks to assess the impact of Modified Pilates Exercises on trunk control in children with Intellectual Disability (ID). ID is characterized by below-average IQ and delays in cognitive and functional development, affecting independence and motor skills. Trunk control plays a crucial role in posture, movement coordination, balance, and daily activities. A total of 40 participants will be selected through non-probability convenience sampling and randomly assigned to two groups: Group A (Modified Pilates Exercises) and Group B (General Physiotherapy Plan). Outcomes will be measured using the Trunk Control Measurement Scale (TCMS) and Pediatric Balance Scale (PBS) at baseline and after 8 weeks. Data will be analyzed using SPSS version 25.
Detailed description
Intellectual Disability (ID) is a condition in which individuals experience below-average IQ. Although a variety of terms, including learning disabilities and mental retardation have been used when referring to people who have impairments that impact on their cognitive and adaptive functioning. ID refers to the onset of delayed developmental milestones, which impact on intellectual and functional development, hence independent functioning is likely to be significantly lower than that of the average person during their lifetime. Trunk control can help children with intellectual disabilities meet developmental milestones by helping them to maintain posture, navigate their surroundings, coordinate body part movement, module fine motor control, initiate vestibule oculomotor reflexes, use their hands for various activities, remain seated without falling over and kept their body aligned while walking, running and jumping.
This study will be randomized controlled trial, conducted in Spectrum clinic, Lahore. This study will be completed in time duration of 8 weeks after the approval of synopsis. Non-probability convenience sampling technique will be used and 40 participants will be recruited in this study. Participants will be divided into two groups. Group A (Modified Pilates Exercises) and Group B (General Physiotherapy Plan). Tools will be used are Trunk control measurement (TCMS) and Pediatric Balance Scale (PBS). The data will be recorded at the baseline and after 8th week of intervention. After collection, data will be analyzed by using SPSS version 25.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be randomized controlled trial, conducted in Mind spark clinic, Lahore. This study will be completed in time duration of 8 weeks after the approval of synopsis. Non-probability convenience sampling technique will be used and 40 participants will be recruited in this study. Participants will be divided into two groups. Group A (Modified Pilates Exercises) and Group B (General Physiotherapy Plan). Tools will be used are Trunk control measurement (TCMS) and Pediatric Balance Scale (PBS). The data will be recorded at the baseline and after 8th week of intervention. After collection, data will be analyzed by using SPSS version 25.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Modified Pilate Exercises, Other: General Physiotherapy Plan: Modified Pilates Exercises, will be given for 8 weeks, 4 times per week. Diaphragmatic Breathing, Bridging and Planks will be given. Intervention Session will be 40-45 minutes with short resting intervals |
| Group B | Experimental | Other: Modified Pilate Exercises, Other: General Physiotherapy PlanGeneral Physiotherapy plan, Will be given for 8 weeks, 4 times per week. Bottom up Exercises, Bridging and Turning over facilitation. Intervention Session will be 40-45 minutes with short resting intervals |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-12 years.
- Diagnosed with mild intellectual disability (IQ 50-70)
- Ability to follow instruction and participate in Pilates Exercises
- No significant physical or neurological conditions that could affect participants
Key exclusion criteria (3 listed)
- Severe intellectual disability(IQ<50)
- Significant physical and neurological conditions (Cerebral palsy, Spinal Cord Injury)
- Visual and Hearing impairments that could impact participation
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 |
|---|---|---|
| Modified Pilate ExercisesModified Pilates exercises are gentle adaptations of traditional Pilates movements, designed to accommodate various fitness levels, physical limitations, or specific health conditions. These exercises focus on core strength, flexibility, posture, and controlled breathing while reducing strain on joints and muscles. Often recommended for beginners, seniors, or individuals recovering from injury or surgery, modified Pilates may involve the use of props like pillows, resistance bands, or chairs to support proper alignment and ease of movement. By emphasizing slow, mindful motions and personalized adjustments, modified Pilates helps individuals safely build strength, improve mobility, and enhance overall body awareness without the risk of overexertion. | Other | Group A, Group B |
| General Physiotherapy PlanA general physiotherapy plan for improving trunk control and balance focuses on enhancing core stability, postural alignment, and coordinated movement through targeted exercises and functional activities. The plan typically begins with gentle activation of deep core muscles such as the transverse abdominis and pelvic floor, progressing to dynamic tasks that challenge balance and coordination, like seated weight shifts, bridging, and reaching tasks in various positions (sitting, kneeling, or standing). Balance training may include exercises on unstable surfaces, gait training, and proprioceptive activities to improve body awareness and stability. The physiotherapy approach is individualized, gradually increasing in complexity and intensity as the patient gains strength and confidence, with consistent emphasis on proper technique, breathing, and safety to support overall mobility and independence. | Other | Group A, Group B |
Primary outcome
Trunk Control Measurement Scale (TCMS)
Time frame: Baseline, 4th week, 8th week
The Trunk Control Measurement Scale (TCMS) is a standardized assessment tool used to measure trunk control in individuals with developmental delay, neurological disorders, or motor impairments. It evaluates posture maintenance, trunk stabilization, and movement across six subtasks, each rated on a scale from 0 to 4 or 0 to 5. The total score ranges from 0 to 24, offering a comprehensive evaluation of trunk control ability. The TCMS identifies specific areas of difficulty, tracks progress over time, and directs targeted interventions to enhance trunk control. Administration involves verbal instructions, visual demonstration, or physical guidance from the evaluator, with the participant performing each task up to three times, scored based on the best attempt
Pediatric Berg Balance Measurement Scale (PBBMS)
Time frame: Baseline, 4th week, 8th week
The Pediatric Berg Balance Measurement (PBBM) is a well-established tool used to assess balance and postural control in children aged 5-15 years. Developed by Berg and colleagues, it comprises 14 items that evaluate standing, sitting, and transitional movements. Scores on the PBBM range from 0 to 56, with higher scores indicating better balance abilities(20). This assessment typically takes 15-20 minutes to administer and is highly reliable and valid. Physiotherapists, occupational therapists, and researchers utilize the PBBM to evaluate balance impairments in children with developmental delays, injuries, or neurological conditions, and to track progress and intervention outcomes effectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 35780104Balayi E, Sedaghati P, Ahmadabadi S. Effects of neuromuscular training on postural control of children with intellectual disability and developmental coordination disorders : Neuromuscular training and postural control. BMC Musculoskelet Disord. 2022 Jul 2;23(1):631. doi: 10.1186/s12891-022-05569-2.
- 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.
Khansa Khizar, MS-PPT 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 Modified Pilate Exercises and General Physiotherapy Plan in people with Mild Intellectual Disability, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (33224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Control Measurement Scale (TCMS) (time frame: Baseline, 4th week, 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06987188, which also lists 1 linked publication.
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 23 May 2025.