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Mindful Movement And GAME BASED Training In Developmental Delay (MINDGAME)

4. Mai 2026 aktualisiert von: Riphah International University

Comparative Effects Of Mindful Movement And Game Based Training On Motor Skills, Balance And Gait In Children With Developmental Delay

Developmental delay in children is characterized by delayed acquisition of cognitive, motor, language, and social skills and is commonly associated with conditions such as cerebral palsy, autism spectrum disorder, and genetic disorders. Children with developmental delay frequently experience impairments in motor skills, balance, and gait, which negatively affect their functional independence and social participation. Addressing these motor deficits is essential to enhance their quality of life.

Mindful movement and game-based training are two therapeutic approaches that have shown potential in improving motor performance in this population. Mindful movement emphasizes slow, controlled movements, body awareness, emotional regulation, imaginative play, and biomechanical warm-up exercises to enhance motor control. In contrast, game-based training employs engaging and interactive activities to improve motor coordination, balance, strength, and social interaction.

This randomized clinical trial aims to compare the effects of mindful movement and game-based training in children with developmental delay. The study will be conducted at PSRD Hospital over a 10-month period and will include 36 children aged 9-11 years selected through non-probability convenience sampling. Participants will be randomly assigned to two groups: Group A will receive mindful movement therapy, and Group B will undergo game-based training. Outcomes will be assessed using validated tools, including the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Pediatric Berg Balance Scale (PBS), Functional Reach Test (FRT), Observational Gait Scale (OGS), and Edinburgh Visual Gait Score (EVGS), to evaluate motor skills, balance, gait, and overall motor proficiency.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Developmental delay in children is characterized by a delay in cognitive, motor, language, and social skills development. It can be associated with conditions like cerebral palsy, autism spectrum disorder (ASD), and genetic disorders. Children with developmental delay often struggle with motor skills, balance, and gait, which can impair their ability to perform everyday tasks and engage socially. Addressing these issues is essential for improving their quality of life. Mindful movement and game-based training are two promising therapeutic interventions. Mindful movement, including practices like imaginative and reflective play, biomechanical warm ups improves motor skills by focusing on slow, deliberate movements, body awareness, and emotional regulation. Game-based training, on the other hand, uses engaging and interactive activities to enhance motor coordination, balance, and strength, while also fostering social interaction and cognitive development. This study is a randomized clinical trial to assess the effects of two interventions-mindful movement and game-based training-on children with developmental delay. It will be conducted at PSRD Hospital, over a 10 month period. The study will involve 36 children aged 9-11 years, diagnosed with developmental delay, and will employ non-probability convenience sampling. The participants will be divided into two groups: Group A will receive mindful movement therapy, while Group B will undergo game-based training. Data will be collected using several assessment tools, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): < 25th percentile (22).Pediatric Berg Balance Scale (PBS) score of less than 45 (23). Functional Reach Test (FRT): < 6-7 inches (22). Observational Gait Scale (OGS): Likert-type scale 0 to 4 (22). Edinburgh Visual Gait Score (EVGS): Scale 0 to 6 (23). all of which have demonstrated strong reliability and validity. These tools will evaluate motor skills, balance, gait, and overall motor proficiency in the children.

Studientyp

Interventionell

Einschreibung (Geschätzt)

36

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Riphah Rehabilitation Center, Riphah International University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Children age 9-11 years
  • Both male and female
  • Children diagnosed with developmental delay
  • Mini mental state examination
  • Participants who are able to understand and follow the instruction
  • Bruininks-Oseretsky Test of Motor Proficiency (BOT-2): < 25th percentile
  • Pediatric Berg Balance Scale (PBS) score of less than 45
  • Functional Reach Test (FRT): < 6-7 inches
  • Observational Gait Scale (OGS): Likert-type scale 0 to 4
  • Edinburgh Visual Gait Score (EVGS): Scale 0 to 6

Exclusion Criteria:

  • Any cognitive impairment that limits understanding of instructions
  • Uncontrolled seizures or medical conditions that contraindicate therapy
  • Participation in other structured physiotherapy programs targeting motor skills, gait and balance
  • Children with other neurological diseases will be excluded

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A: Mindful Movement Intervention
Participants in Arm A will receive a mindful movement program aimed at improving motor skills, balance, coordination, and emotional regulation.
Verhalten: Mindful movement

The intervention includes biomechanical warm-up exercises, imaginative play, animal-based movements, and reflective activities to enhance body awareness, posture, focus, and relaxation. Emphasis is placed on slow, controlled movements to promote mindfulness and overall physical and mental well-being. Each session will last 45 minutes, conducted three times per week, total 12 sessions.

Components include:

Biomechanical warm-ups: Gentle joint mobility exercises such as shoulder circles and slow marching (5-10 minutes).

Imaginative play: Creative movement activities (e.g., tree pose with storytelling, emotion walks, breathing with hand tracing) , Animal walks(bear crawl, crab walk, frog jumps) to improve strength, coordination, and balance (approximately 30 minutes).

Reflection: Mirror movements and "balloon hands" using slow, controlled hand movements to promote relaxation and motor control (5 minutes).
Experimental: Arm B: Game-Based Training Intervention
Participants in Arm B will receive a game-based training program designed to improve motor skills, balance, gait, strength, and overall fitness through engaging and age-appropriate games.
Verhalten: Game based training

The intervention emphasizes active participation, enjoyment, and cognitive engagement. Each session will last 45 minutes, conducted three times per week, total 12 sessions.

Components include:

Warm-up: Walking activities to increase body temperature (5-10 minutes).

Main practice: Game-based aerobic, strength, balance, and coordination activities such as The Sea, The Astronauts, Give Your Ball, and The Game of Colors (approximately 30 minutes).

Cool-down: Deep breathing exercises to promote relaxation and reduce heart rate (5 minutes).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Motor Skill Performance
Zeitfenster: Baseline and 4 weeks
Tool: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) Outcome: Change in BOT-2 total motor composite score The BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency, Second Edition) scoring converts raw scores into precise motor proficiency metrics for ages 4-21, using sex-specific norms.
Baseline and 4 weeks
Balance Ability
Zeitfenster: Baseline and 4 weeks
Tool: Pediatric Berg Balance Scale (PBS) Outcome: Change in PBS score
Baseline and 4 weeks
Gait Quality
Zeitfenster: Baseline and 4 weeks
Tools: Observational Gait Scale (OGS); The Observational Gait Scale (OGS) is a validated tool used to assess gait quality, particularly in children with cerebral palsy, by scoring key kinematic parameters from video or direct observation. It rates 8 specific gait components in the sagittal plane-including knee position, foot contact, and heel rise-resulting in a maximum score of 22 per limb. Lower scores indicate greater impairments
Baseline and 4 weeks
Edinburgh Gait Scale
Zeitfenster: Baseline and 4 weeks
The Edinburgh Visual Gait Score (EVGS) is a comprehensive, video-based observational tool used to assess gait abnormalities, primarily in children with cerebral palsy (CP). It evaluates 17 parameters per limb across sagittal and coronal planes-focusing on the foot, knee, hip, pelvis, and trunk-using a 3-point ordinal scale (0=normal, 1=mild/moderate, 2=severe).
Baseline and 4 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Riphah International University

Ermittler

  • Hauptermittler: Khadija Liaquat, MS, Riphah International University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

1. August 2026

Studienabschluss (Geschätzt)

25. August 2026

Studienanmeldedaten

Zuerst eingereicht

14. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2026

Zuerst gepostet (Tatsächlich)

8. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Riphah IU Nimra

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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