NCT07428837

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

November 18, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

Pilates Down syndrome, cognitive-motor training exercises.postural stability,

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline,8 weeks

Study Arms (2)

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.

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

Other: pilates exercises

Interventions

. 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.

cognitive-motor training with baseline trearment of 45 minutes.

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

pilates exercises with baseline treatment of 45 minutes.

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilal Hussain

Islamabad, 10250, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38558387BACKGROUND

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • FARAH NOREEN, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

February 24, 2026

Study Start

October 29, 2025

Primary Completion

February 20, 2026

Study Completion

February 23, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations