ChildrenNCT07428837
Effect of Cognitive-motor Training Versus Pilates Exercises on Postural Stability in Down Syndrome.
A study testing cognitive-motor training and pilates exercises in people with Children, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be randomized clinical trial. Data will be collected from City hospital, Mirpur AJK. Total thirty two subjects will be assigned randomly by using lottery randomization into two groups. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Children
- What is being tested?
- cognitive-motor training and pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Oct 2025to 23 Feb 2026
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed with Down syndrome.
- Age between 8 to 13 years.
- Patient able to understand instructions necessary for intervention.
- Independent standing and walking abilities.
- Both the genders will included.
Who cannot join
- Severe mental retardation.
- Any heart deficit.
- Visual impairments.
- Musculoskeletal or mobility disorder.
- Hearing impairements.
- Signs of epilepsy or instability of atlanto axial joint.
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
Bilal Hussain
Islamabad, 10250
BILAL HUSSAIN, MS-PT, 03318130698, bilalhussain4747@gmail.com
FARAH NOREEN, MS-PT, 03118983148, farahnoreen213@gmail.com
About this study
Official title: Effect of Cognitive-motor Training Versus Pilates Exercises on Postural Stability in Children With Down Syndrome.
The study will be randomized clinical trial. Data will be collected from City hospital, Mirpur AJK. Total thirty two subjects will be assigned randomly by using lottery randomization into two groups. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlantooccipital joint will be excluded. Group A will receive cognitive-motor training while group B will receive Pilates exercises. Treatment session will be of 8 weeks. Peadriatic balance scale and trunk control measurement scale will be used to assess postural stability. Measure will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 23.00.If data be normally distributed then parametric if not normally distributed than non-parametric.
Read the detailed description
Postural instability or difficulty maintaining balance is a commom challenge in individuals with Down syndrome due to combination of hypotonia, joint laxity, delayed motor skills, sensory processing issues, cognitive and neurological differences, visual and vestibular challenges. In cognitive-motor training, both locomotor skills and object control exercises (dual tasks, dancing and rhythm games, reaction time exercises and puzzle game with physical exercises) will performed by participants. Pilates exercises includes bridging, hundred, single leg circles, alternate toe tap, ball wall squat will be performed by the participants. The aim of this study is to determine the effects of cognitive-motor training and Pilates exercises on postural stability in children with Down syndrome. The study will be randomized clinical trial. Data will be collected from City hospital, Mirpur AJK. Total thirty two subjects will be assigned randomly by using lottery randomization into two groups. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlantooccipital joint will be excluded. Group A will receive cognitive-motor training while group B will receive Pilates exercises. Treatment session will be of 8 weeks. Peadriatic balance scale and trunk control measurement scale will be used to assess postural stability. Measure will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 23.00.If data be normally distributed then parametric if not normally distributed than non-parametric.
- Conditions
- Children
- Being tested
- cognitive-motor training, pilates exercises
- Keywords
- Pilates Down syndrome, cognitive-motor training exercises., postural stability,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-motor trainingOther
. Warm-Up (5-10 minutes)
Physical:
Gentle stretching and simple movements like arm swings, leg lifts, or walking in place. Breathing exercises to promote relaxation and focus.
Cognitive:
Engage in simple attention exercises, such as pointing to different colors, naming objects, or counting aloud while performing light physical movements.
Balance and Coordination (10-15 minutes) Activities, Dual-Task Training (20-30 minutes)
,Combining Cognitive and Motor Skills. Throwing and catching,Dance and rhythm games,
Encourage dance movements while following a rhythm pattern. This helps with coordination and timing. Memory while moving,Reaction time exercises, Use visual or auditory cues (like clapping or flashing lights) to prompt specific movements. For example, when the light turns green, the child can move forward; when it turns red, they stop and name a color.Puzzle games with physical activity.
pilates exercisesOther
Pilates exercises protocol:
In Supine, Make circles with one raised lower limb in a clockwise direction and then in a counter-clockwise direction. Ball wall squat Bridge In Crook lying position, lifting the pelvis of the mat. Hundred In Supine position,lifting the head, followed by lifting both legs 30 degrees with both knees flexed and then gradually with both knees extended. Alternate toe taps In Supine with 90 degrees flexion of both hips and knees. Alternate tapping of toes on the mat. Single leg circles
| Study group | Role | What they receive |
|---|---|---|
| cognitive-motor training with baseline trearment of 45 minutes. | Active comparator | Gentle stretching and simple movements like arm swings, leg lifts, or walking in place. Breathing exercises to promote relaxation and focus.Cognitive: Engage in simple attention exercises, such as pointing to different colors, naming objects, or counting aloud while performing light physical movements, Balance and Coordination Activities, Dual-Task Training, Dance and rhythm games, Reaction time exercises and Puzzle games with physical activity. Receives: Other: cognitive-motor training |
| pilates exercises with baseline treatment of 45 minutes. | Active comparator | Pilates exercises protocol:In Supine, Make circles with one raised lower limb in a clockwise direction and then in a counter-clockwise direction.Ball wall squat BridgeIn Crook lying position.Hundred. In Supine position, lifting the head, followed by lifting both legs 30 degrees with both knees flexed and then gradually with both knees extended.
Alternate toe taps. In Supine with 90 degrees flexion of both hips and knees. Alternate tapping of toes on the mat. Single leg circles Standing against a wall while a Swiss ball is in the lumber, Area Performing semisquat(1).
Intervention period will be of 8 weeks with 3 to 4 sessions per week Receives: Other: pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: baseline,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 Feb 2026
- Study start29 Oct 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion23 Feb 2026 (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 ChildrenStudies 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
- Postural instability or difficulty maintaining balance is a commom challenge in individuals with Down syndrome due to combination of hypotonia, joint laxity, delayed motor skills, sensory processing issues, cognitive and neurological differences, visual and vestibular challenges. In cognitive-motor training, both locomotor skills and object control exercises (dual tasks, dancing and rhythm games, reaction time exercises and puzzle game with physical exercises) will performed by participants. Pilates exercises includes bridging, hundred, single leg circles, alternate toe tap, ball wall squat will be performed by the participants. The aim of this study is to determine the effects of cognitive-motor training and Pilates exercises on postural stability in children with Down syndrome.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FARAH NOREEN, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428837
- Sponsor's protocol ID
- REC/RCR&AHS/FARAH NOREEN
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Nemr A, Reffat S. Effect of Pilates exercises on balance and gross motor coordination in children with Down syndrome. Acta Neurol Belg. 2024 Oct;124(5):1499-1505. doi: 10.1007/s13760-024-02517-w. Epub 2024 Apr 1.
PubMed 38558387
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive-motor Training Versus Pilates Exercises on Postural Stability in Children With Down Syndrome.
- ClinicalTrials.gov ID
- NCT07428837
- Acronym / sponsor ID
- REC/RCR&AHS/FARAH NOREEN
- Conditions
- Children
- Keywords
- Pilates Down syndrome, cognitive-motor training exercises., postural stability,
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 24 Feb 2026 (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.
The study will be randomized clinical trial. Data will be collected from City hospital, Mirpur AJK. Total thirty two subjects will be assigned randomly by using lottery randomization into two groups. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlantooccipital joint will be excluded. Group A will receive cognitive-motor training while group B will receive Pilates exercises. Treatment session will be of 8 weeks. Peadriatic balance scale and trunk control measurement scale will be used to assess postural stability. Measure will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 23.00.If data be normally distributed then parametric if not normally distributed than non-parametric.
Detailed description
Postural instability or difficulty maintaining balance is a commom challenge in individuals with Down syndrome due to combination of hypotonia, joint laxity, delayed motor skills, sensory processing issues, cognitive and neurological differences, visual and vestibular challenges. In cognitive-motor training, both locomotor skills and object control exercises (dual tasks, dancing and rhythm games, reaction time exercises and puzzle game with physical exercises) will performed by participants. Pilates exercises includes bridging, hundred, single leg circles, alternate toe tap, ball wall squat will be performed by the participants. The aim of this study is to determine the effects of cognitive-motor training and Pilates exercises on postural stability in children with Down syndrome. The study will be randomized clinical trial. Data will be collected from City hospital, Mirpur AJK. Total thirty two subjects will be assigned randomly by using lottery randomization into two groups. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlantooccipital joint will be excluded. Group A will receive cognitive-motor training while group B will receive Pilates exercises. Treatment session will be of 8 weeks. Peadriatic balance scale and trunk control measurement scale will be used to assess postural stability. Measure will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 23.00.If data be normally distributed then parametric if not normally distributed than non-parametric.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Postural instability or difficulty maintaining balance is a commom challenge in individuals with Down syndrome due to combination of hypotonia, joint laxity, delayed motor skills, sensory processing issues, cognitive and neurological differences, visual and vestibular challenges. In cognitive-motor training, both locomotor skills and object control exercises (dual tasks, dancing and rhythm games, reaction time exercises and puzzle game with physical exercises) will performed by participants. Pilates exercises includes bridging, hundred, single leg circles, alternate toe tap, ball wall squat will be performed by the participants. The aim of this study is to determine the effects of cognitive-motor training and Pilates exercises on postural stability in children with Down syndrome.
| Arm | Type | Receives |
|---|---|---|
| cognitive-motor training with baseline trearment of 45 minutes. | Active comparator | Other: cognitive-motor trainingGentle stretching and simple movements like arm swings, leg lifts, or walking in place. Breathing exercises to promote relaxation and focus.Cognitive: Engage in simple attention exercises, such as pointing to different colors, naming objects, or counting aloud while performing light physical movements, Balance and Coordination Activities, Dual-Task Training, Dance and rhythm games, Reaction time exercises and Puzzle games with physical activity. |
| pilates exercises with baseline treatment of 45 minutes. | Active comparator | Other: pilates exercisesPilates exercises protocol:In Supine, Make circles with one raised lower limb in a clockwise direction and then in a counter-clockwise direction.Ball wall squat BridgeIn Crook lying position.Hundred. In Supine position, lifting the head, followed by lifting both legs 30 degrees with both knees flexed and then gradually with both knees extended. Alternate toe taps. In Supine with 90 degrees flexion of both hips and knees. Alternate tapping of toes on the mat. Single leg circles Standing against a wall while a Swiss ball is in the lumber, Area Performing semisquat(1). Intervention period will be of 8 weeks with 3 to 4 sessions per week |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients diagnosed with Down syndrome.
- Age between 8 to 13 years.
- Patient able to understand instructions necessary for intervention.
- Independent standing and walking abilities.
- Both the genders will included.
Key exclusion criteria (6 listed)
- Severe mental retardation.
- Any heart deficit.
- Visual impairments.
- Musculoskeletal or mobility disorder.
- Hearing impairements.
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 |
|---|---|---|
| cognitive-motor training. Warm-Up (5-10 minutes) Physical: Gentle stretching and simple movements like arm swings, leg lifts, or walking in place. Breathing exercises to promote relaxation and focus. Cognitive: Engage in simple attention exercises, such as pointing to different colors, naming objects, or counting aloud while performing light physical movements. Balance and Coordination (10-15 minutes) Activities, Dual-Task Training (20-30 minutes) ,Combining Cognitive and Motor Skills. Throwing and catching,Dance and rhythm games, Encourage dance movements while following a rhythm pattern. This helps with coordination and timing. Memory while moving,Reaction time exercises, Use visual or auditory cues (like clapping or flashing lights) to prompt specific movements. For example, when the light turns green, the child can move forward; when it turns red, they stop and name a color.Puzzle games with physical activity. | Other | cognitive-motor training with baseline trearment of 45 minutes. |
| pilates exercisesPilates exercises protocol: In Supine, Make circles with one raised lower limb in a clockwise direction and then in a counter-clockwise direction. Ball wall squat Bridge In Crook lying position, lifting the pelvis of the mat. Hundred In Supine position,lifting the head, followed by lifting both legs 30 degrees with both knees flexed and then gradually with both knees extended. Alternate toe taps In Supine with 90 degrees flexion of both hips and knees. Alternate tapping of toes on the mat. Single leg circles | Other | pilates exercises with baseline treatment of 45 minutes. |
Primary outcome
Pediatric Balance Scale
Time frame: baseline,8 weeks
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
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 24 Feb 2026.
- Background: PubMed 38558387Al-Nemr A, Reffat S. Effect of Pilates exercises on balance and gross motor coordination in children with Down syndrome. Acta Neurol Belg. 2024 Oct;124(5):1499-1505. doi: 10.1007/s13760-024-02517-w. Epub 2024 Apr 1.
- 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.
FARAH NOREEN, MS-PT 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 cognitive-motor training and pilates exercises in people with Children, 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 6 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 24 Feb 2026. 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 (9233224390125, 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?
Pediatric Balance Scale (time frame: baseline,8 weeks). 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 NCT07428837, 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 24 Feb 2026.