NCT07307105

Brief Summary

Children with developmental delay often face challenges in motor skills, balance, and overall quality of life, requiring interventions that are both effective and engaging. The purpose of this study is to improving these areas and investigating comparative effects of both creative movement and play based intervention that can help identify the most effective approach for enhancing motor abilities, balance, and overall well-being in this population

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 26, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 14, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

Balance, Quality of Life, Developmental Delay, Motor Skills

Outcome Measures

Primary Outcomes (2)

  • PedsQL.

    Is a standardized, validated tool designed to measure health-related quality of life (HRQOL) in children and adolescents aged 2-18 years. The Turkish validity and reliability tests of the form were performed by Memik et al. (2008). There are other versions of this data collection tool which were developed for different age groups. There is a Likert type answer scale with five answer options: (0 ¼ never, 1 ¼ seldom, 2 ¼ sometimes, 3 ¼ often, 4 ¼ always). The points which are obtained from the items are calculated and a score between 0 and 100 is linearly obtained (0 ¼ 100, 1 ¼ 75, 2 ¼ 50, 3 ¼ 25, 4 ¼ 0). A score between 0 and 100 indicates the quality of life score and an increase in the scores means an increase in the quality of life.

    8 weeks

  • Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for fine and gross Motor Skills

    Is a widely recognized and reliable tool for evaluating both fine and gross motor skills in children aged 4 to 21 years. The shorter form of the test consists of fourteen subtests, which assess fine motor precision and integration, bilateral coordination, balance, running speed, agility, upper body coordination, and strength. The reliability of all the mentioned items is above 0.70, with overall internal consistency reliability ranging from 0.80 to 0.90, and test-retest reliability reported between 0.80 and 0.87, indicating strong measurement stability. It should be noted that the test validity and reliability were established in a sample of healthy children. The short form includes five fine motor skill tests (Drawing, Lines through Paths-Crooked, Folding Paper, Copying a Square, Copying a Star, Transferring Pennies) and nine gross motor tasks (Jumping in Place-Same Sides Synchronized, Tapping Feet and Fingers-Same Sides Synchronized, Walking Forward on a Line, Standing on

    8 weeks

Secondary Outcomes (1)

  • Pediatric Balance Scale PBS for Functional Balance

    8 weeks

Study Arms (2)

Creative Movement intervention group.

EXPERIMENTAL

Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination,

Behavioral: creative movement intervention

Play-Based intervention group

EXPERIMENTAL

Group B (Play-Based Intervention) included obstacle courses, dual-limb coordination games, story reading, building tasks (blocks/LEGOs), and arts \& crafts for fine motor development. Each session concluded with a cool-down, promoting relaxation and emotional regulation

Behavioral: play based intervention

Interventions

Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination, strength exercises (Grow Strong segment), locomotor games, yoga with breathing, and music-making with instruments. Each session lasted 60 minutes and was conducted twice weekly for 8 weeks

Creative Movement intervention group.

Group B (Play-Based Intervention) included obstacle courses, dual-limb coordination games, story reading, building tasks (blocks/LEGOs), and arts \& crafts for fine motor development. Each session concluded with a cool-down, promoting relaxation and emotional regulation

Play-Based intervention group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
inclusion : 1. Children aged 5-8 years. 2. Both girls and boys . 3. Mini-Mental State Examination (MMSE) score \> 24 . 4. Stork Stand Balance Test (both legs) \> 4 seconds . 5. Pediatric Berg Balance Scale score ≥ 40 . 6. TGMD-2 GMQ score ≤ 79 (≤ 25th percentile) . 7. BOT-2 Total Motor Composite score ≤ 18th percentile . 8. PedsQL total score ≤ 70 Exclusion : 1. Musculoskeletal Impairments affecting posture. 2. balance. 3. Uncorrected visual or auditory impairments . 4. Behavioral or Attention Disorders that may impair test compliance or affect performance reliability . 5. Recent Surgery or Injury in the past 6 months . 6. Use of Assistive Devices . 7. Chronic Illness Affecting Physical Activity . 8. Participation in specialized motor training in the past 3 months . 9. Inability to follow instructions or complete assessments (TGMD-2, BOT-2, PedsQL).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Rax clinic iqbal town

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Learning Disabilities

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior lecturer

Study Record Dates

First Submitted

December 14, 2025

First Posted

December 29, 2025

Study Start

October 26, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations