- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07925645
Investigation of the Effects of Kinesthetic Brain Exercises in Preschool Children
Investigation of the Effects of Kinesthetic Brain Exercises on Physical, Cognitive, and Psychosocial Parameters in Preschool Children
This study will investigate whether kinesthetic brain exercises affect physical, cognitive, and psychosocial outcomes in preschool children. Fifty children aged 3-6 years from two preschool classes will participate. One class will be randomly assigned to the exercise group and the other to the control group.
Children in the exercise group will participate in play-based movement activities supervised by a physiotherapist for 8 weeks, twice a week, for 30-40 minutes per session. Activities will include coordinated movements, ball games, and exercises combining movement with attention tasks. Children in the control group will continue their usual preschool education.
Both groups will be assessed before and after the 8-week period. The assessments will examine motor skills, attention, posture, lower-limb functional performance, fatigue, social skills and behavior, sleep habits, problematic media use, and quality of life.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This master's thesis study is designed as a two-arm, cluster-randomized controlled trial conducted in a preschool education setting. Two existing classes will serve as the clusters. Using a closed-envelope procedure, one class will be allocated to the kinesthetic brain exercise group and the other to the control group. The planned enrollment is 50 children, with 25 children per group. Written informed consent will be obtained from a parent or legal guardian before participation.
The intervention will consist of 16 physiotherapist-supervised sessions delivered over 8 weeks. Each session will last approximately 30-40 minutes and include warm-up, exercise, and cool-down phases. Activities will be delivered in a play-based format appropriate to the children's age and developmental level.
Warm-up activities will include brain buttons, the thinking cap, the elephant, the owl, and cross crawl. The main exercise phase will include throwing balls into the air, jumping to either side of a straight line, stepping while throwing a ball, stepping in response to instructions, bouncing a ball with one hand while drawing circles with the other, and touching the head with one hand while drawing circles with the other. Cool-down activities will include the double doodle, lazy eights, arm activity, foot flex, and calf pumping.
The control group will continue its routine preschool education without receiving the study exercise program during the 8-week comparison period. After the final assessments, children in the control group will be offered the exercise program on an optional basis.
Assessments will be performed at baseline and at the end of the 8-week period by the same researcher. Between-group comparisons of changes over time will be used to examine the effects of the intervention.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Betül TAŞPINAR, Prof. Dr.
- Numero di telefono: +90 506 680 44 26
- Email: ptbetul@gmail.com
Backup dei contatti dello studio
- Nome: Funda ÇETİN, PT
- Numero di telefono: +90 553 685 58 92
- Email: fundaccetin@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Children aged 3-6 years.
Attending a preschool education institution.
Written informed consent provided by a parent or legal guardian.
Sufficient cognitive and behavioral ability to understand the planned assessments and participate in the study activities.
Able to attend the planned study sessions regularly.
Exclusion Criteria:
A diagnosed neurological condition, such as cerebral palsy or epilepsy.
A diagnosed orthopedic or musculoskeletal disorder.
A diagnosis of developmental delay or severe learning difficulties.
Attention, behavioral, or adjustment problems that prevent participation in the study.
A chronic disease that restricts regular physical activity.
Anticipated absences that would prevent regular participation during the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Kinesthetic Brain Exercise Group
Children will participate in a physiotherapist-supervised kinesthetic brain exercise program for 8 weeks, twice weekly, for 30-40 minutes per session. The program will include warm-up, exercise, and cool-down activities delivered in an age-appropriate, play-based format. |
The program consists of three phases. Warm-up activities include brain buttons, the thinking cap, the elephant, the owl, and cross crawl. The exercise phase includes throwing balls into the air, jumping to either side of a straight line, stepping while throwing a ball, stepping in response to instructions, bouncing a ball with one hand while drawing circles with the other, and touching the head with one hand while drawing circles with the other. Cool-down activities include the double doodle, lazy eights, arm activity, foot flex, and calf pumping. |
|
Nessun intervento: Control Group
Children will continue their routine preschool education without receiving the study exercise program during the 8-week study period. After the final assessments, they will be offered the kinesthetic brain exercise program on an optional basis. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Gross Motor Skills Assessed With the Test of Gross Motor Development-Second Edition (TGMD-2)
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Gross motor skills will be assessed using the Test of Gross Motor Development-Second Edition (TGMD-2). The test includes two subtests: locomotor skills and object control skills, each comprising six skills. The total raw score ranges from 0 to 96, with higher scores indicating better gross motor skill performance. The change in total raw score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Posture Assessed With the New York Posture Rating Chart
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Posture will be assessed using the New York Posture Rating Chart, which evaluates 13 body regions. Each region is scored as 5 for normal alignment, 3 for moderately impaired alignment, or 1 for severely impaired alignment. Total scores range from 13 to 65, with higher scores indicating better postural alignment. The change in total score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
|
Change in Lower-Limb Functional Performance Assessed With the Five Times Sit-to-Stand Test
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Lower-limb functional performance will be assessed using the Five Times Sit-to-Stand Test. The child will be asked to stand up from and sit down on a standard chair five consecutive times as quickly as possible, with arms crossed over the chest. Completion time will be recorded in seconds using a stopwatch. Three trials will be performed, and the mean completion time will be calculated. Shorter completion times indicate better functional performance. The change in mean completion time from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
|
Change in Fatigue Assessed With a Faces Rating Scale
Lasso di tempo: Baseline and at the end of 8 weeks
|
Fatigue will be assessed using a visual faces rating scale adapted for children. The scale contains six facial expressions scored as 0, 2, 4, 6, 8, and 10. Children will select the face that best represents their fatigue level, with 0 indicating no fatigue and 10 indicating very severe fatigue. Higher scores indicate greater fatigue. The change in score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks
|
|
Change in Attention Assessed With the Frankfurter Attention Test
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Attention will be assessed using the Frankfurter Attention Test. Children will be asked to identify and mark pear symbols among apple symbols within 90 seconds. The raw score is the number of correctly marked pears, ranging from 0 to 42. Higher scores indicate better attention performance. The change in raw score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
|
Change in Social Skills Assessed With the Preschool and Kindergarten Behavior Scales
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Social skills will be assessed using the 23-item Social Skills Scale of the Turkish version of the Preschool and Kindergarten Behavior Scales (PKBS). The scale evaluates social cooperation, social independence and acceptance, and social interaction. Items are rated according to the frequency of the observed behavior. Higher total scores indicate better social skills. The change in total score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
|
Change in Problem Behaviors Assessed With the Preschool and Kindergarten Behavior Scales
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Problem behaviors will be assessed using the 27-item Problem Behavior Scale of the Turkish version of the Preschool and Kindergarten Behavior Scales (PKBS). Items are rated according to the frequency of the observed behavior. Higher total scores indicate more frequent problem behaviors. The change in total score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
|
Change in Sleep Habits Assessed With the Children's Sleep Habits Questionnaire
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Sleep habits will be assessed using the parent-reported Children's Sleep Habits Questionnaire (CSHQ). The questionnaire includes 33 scored items covering bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Items are scored from 1 to 3, with reverse scoring where applicable. Total scores range from 33 to 99, with higher scores indicating greater sleep-related difficulties. The change in total score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
|
Change in Problematic Media Use Assessed With the Problematic Media Use Measure
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Problematic media use will be assessed using the 27-item parent-reported long form of the Problematic Media Use Measure (PMUM). Parents will rate their child's behavior during the previous month on a five-point scale from 1 (never) to 5 (always). The overall score is calculated as the mean of the 27 item scores and ranges from 1 to 5. Higher scores indicate greater problematic media use. The change in mean score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
|
Change in Health-Related Quality of Life Assessed With the Pediatric Quality of Life Inventory
Lasso di tempo: Baseline and at the end of 8 weeks.
|
Health-related quality of life will be assessed using the parent-proxy report of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales. The questionnaire assesses physical, emotional, social, and school functioning during the previous month. Responses are reverse-scored and transformed to a scale from 0 to 100. The total score is calculated as the mean of the scored items, with higher scores indicating better health-related quality of life. The change in total score from baseline to the end of the 8-week intervention period will be evaluated. |
Baseline and at the end of 8 weeks.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Betül TAŞPINAR, Prof. Dr., Izmir Democracy University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- KBE-PRESCHOOL CHILDREN-35
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .