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NCT Number: NCT07428837

Effect of Cognitive-motor Training Versus Pilates Exercises on Postural Stability in 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.

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Key information

Conditions

Children

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Severe mental retardation.
  • Any heart deficit.
  • Visual impairments.
  • Musculoskeletal or mobility disorder.
  • Hearing impairements.
  • Signs of epilepsy or instability of atlanto axial joint.

Treatment and study plan

Cognitive-motor training

Other

. 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 exercises

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Cognitive-motor Training Versus Pilates Exercises on Postural Stability in Children With Down Syndrome.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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