NCT07756931

Brief Summary

Conducted as a randomized trial, this study examines the impact of rainbow parachute games on upper extremity strength and social-emotional skills in children (ages 5-8) with developmental delays. Participants will be randomly divided experimental and control groups. The experimental group performs parachute activities for 8 weeks, while the control group does rhyming activities. Outcomes measured by "Hand held Dynamometer" and "Pediatric Arm Function Test (PAFT)" for upper extremity strength and Social-Emotional skills will be measured by "Strengths and Difficulties Questionnaire (SDQ)". Statistical analysis will be performed using SPSS version 2023 to determine the Intervention's effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

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
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

July 27, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

upper extremity, developmental delay, grip strength

Outcome Measures

Primary Outcomes (2)

  • Social-Emotional skills by Strengths and Difficulties Questionnaire

    Social-Emotional skills will be measured by "Strengths and Difficulties Questionnaire (SDQ)". The Strengths and Difficulties Questionnaire (SDQ) is a 25-item behavioral screening tool for children and young people aged 2 to 17. It uses a 3-point response scale ("Not True," "Somewhat True," and "Certainly True") mapped across five subscales, a Total Difficulties score, and an Impact score

    8 weeks

  • Upper Extremity Strength by Pediatric Arm Function Test

    Pediatric Arm Function Test (PAFT) will be used to access upper extremity strength, The Pediatric Arm Function Test (PAFT) is scored by trained occupational therapists who evaluate video recordings of a child (typically ages 2 to 12 with hemiparesis) completing specific functional and play tasks. It uses two primary sub-scales: the Functional Ability scale (rating movement quality/execution of the more-affected arm) and the Limb Preference scale (calculating the percentage of tasks spontaneously attempted with that arm)

    8 weeks

Study Arms (2)

Group A : Intervention Group (Rainbow parachute Games and Rhyming Activities)

EXPERIMENTAL

The participants in this group will receive both the Rhyming activities and Rainbow parachute game activities. Rhyming activities will be performed first, participants will clap or make patterns with hands in air on the words that rhyme, once they're already familiar with the text (Little mouse, The bird), directions will be given and shown how to wave and make patterns with variations and rhythm these activities will be performed for 20 min. After Rhyming activities, Parachute activities will be performed in 25-30min. Intervention will be given for 8 weeks (3 sessions/week). Each session will take 45-50 mins. The intervention consists of different play activities with Rainbow parachute

Other: Rainbow parachute GamesOther: Rhyming Activities

Group B: Control Group (Rhyming Activities)

EXPERIMENTAL

Participants in the control group will perform Rhyming activities participants will clap or make patterns with hands in air on the words that rhyme, once they're already familiar with the text (Little mouse, The bird), directions will be given and shown how to wave and make patterns with variations and rhythm these activities will be performed for 20 mins

Other: Rhyming Activities

Interventions

Group A : The participants in this group will receive both the Rhyming activities and Rainbow parachute game activities. Rhyming activities will be performed first, participants will clap or make patterns with hands in air on the words that rhyme, once they're already familiar with the text (Little mouse, The bird), directions will be given and shown how to wave and make patterns with variations and rhythm these activities will be performed for 20 min. After Rhyming activities, Parachute activities will be performed in 25-30min. Intervention will be given for 8 weeks (3 sessions/week). Each session will take 45-50 mins. The intervention consists of different play activities with Rainbow parachute. Activities like Make waves, Treasure under the sea, Mushroom, Cat and mouse, Paracute Tug will be performed and pre and post results will be analysed

Also known as: Rhyming Activities
Group A : Intervention Group (Rainbow parachute Games and Rhyming Activities)

Group B : Participants in the control group will perform Rhyming activities participants will clap or make patterns with hands in air on the words that rhyme, once they're already familiar with the text (Little mouse, The bird), directions will be given and shown how to wave and make patterns with variations and rhythm these activities will be performed for 20 mins.

Group A : Intervention Group (Rainbow parachute Games and Rhyming Activities)Group B: Control Group (Rhyming Activities)

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5-8 years.
  • Diagnosed with motor developmental Delay.
  • Both Girls and Boys will be Included.

You may not qualify if:

  • Severe Physical Disability.
  • Uncontrolled medical Health conditions that contraindicate Physical activity.
  • Severe Visual or Auditory impairments that limit engagement in group activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Brian A, Pennell A, Taunton S, Starrett A, Howard-Shaughnessy C, Goodway JD, Wadsworth D, Rudisill M, Stodden D. Motor Competence Levels and Developmental Delay in Early Childhood: A Multicenter Cross-Sectional Study Conducted in the USA. Sports Med. 2019 Oct;49(10):1609-1618. doi: 10.1007/s40279-019-01150-5.

    PMID: 31301035BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

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

Study Officials

  • Arooj Abid, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask both groups about the treatment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study examines the impact of rainbow parachute games on physical strength and social-emotional skills in children (ages 5-8) with developmental delays. In a randomized controlled trial, 12 children are divided into experimental and control groups. The experimental group performs parachute activities for 8 weeks, while the control group does rhyming activities. Upper Extremity Strength will be measured by "Hand held Dynamometer" and "Pediatric Arm Function Test (PAFT)". Social-Emotional skills will be measured by "Strengths and Difficulties Questionnaire (SDQ)".
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 11, 2026

Study Start

October 28, 2025

Primary Completion

June 25, 2026

Study Completion

July 15, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations