NCT06987188

Brief 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). 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

April 16, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 15, 2025

Last Update Submit

May 15, 2025

Conditions

Keywords

Mild Intellectual DisabilityTrunk controlBalancePhysical therapypilate exercises

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Baseline, 4th week, 8th week

Study Arms (2)

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

Other: Modified Pilate ExercisesOther: 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

Other: Modified Pilate ExercisesOther: General Physiotherapy Plan

Interventions

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.

Group AGroup B

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.

Group AGroup B

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Severe intellectual disability(IQ\<50)
  • Significant physical and neurological conditions (Cerebral palsy, Spinal Cord Injury)
  • Visual and Hearing impairments that could impact participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising Sun Institute

Lahore, Pinjab, 54900, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35780104BACKGROUND

Study Officials

  • Khansa Khizar, MS-PPT

    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
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2025

First Posted

May 23, 2025

Study Start

April 16, 2025

Primary Completion

June 11, 2025

Study Completion

June 11, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations