Sensory-Motor Integration Versus Virtual Reality-Based Exercise in Children With Cerebral Palsy
Comparative Clinical Effectiveness of Sensory-Motor Integration and Virtual Reality-Based Exercise Programs for Enhancing Functional Mobility in Children With Cerebral Palsy: Strengthening Steps Through Play and Technology
This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Both groups will continue to receive standard conventional physiotherapy. In addition, one group will receive a structured sensory-motor integration-based exercise program, while the other group will receive a Nintendo Wii Sports-based virtual reality exercise program. The intervention period will last 16 weeks, with two sessions per week. Outcomes will be assessed before and after the intervention using standardized clinical measures.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Cerebral palsy is a non-progressive neurodevelopmental condition characterized by permanent impairments in movement, posture, and motor function. Children with cerebral palsy may experience limitations in postural control, balance, motor planning, sensory processing, functional mobility, and participation in physical activity. Conventional physiotherapy is widely used in the rehabilitation of children with cerebral palsy and commonly includes tone regulation, stretching, strengthening, balance training, aerobic exercises, and functional activity training. However, additional rehabilitation approaches may be needed to support multidimensional motor and functional outcomes.
This study is designed as a two-arm, randomized controlled, parallel-group, prospective clinical intervention study. The aim is to compare the effects of two adjunctive rehabilitation approaches added to standard conventional physiotherapy: a Sensory-Motor Integration-Based Exercise Program and a Virtual Reality-Based Exercise Program using Nintendo Wii Sports.
Eligible children with cerebral palsy will be enrolled after obtaining informed consent from their legal guardians. Participants will be randomly assigned to one of two groups using a computer-based simple randomization method.
Participants in the first group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. This program is designed to target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs.
Participants in the second group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. This program will provide visual and auditory feedback in a game-based environment and will aim to increase motivation, task-oriented movement repetition, balance, and functional motor performance.
The intervention period will last 16 weeks, with two sessions per week for both groups. All participants will be evaluated at baseline before the intervention and after completion of the 16-week intervention period. The primary outcome measures will include the Gross Motor Function Measure dimensions D and E, the Pediatric Balance Scale, and the Timed Up and Go Test. Secondary outcome measures will include ABILHAND-Kids, hand grip strength measured with a dynamometer, and the Physical Activity Self-Efficacy Scale for Children.
The study is expected to provide clinical evidence regarding the comparative effectiveness of sensory-motor integration-based exercises and virtual reality-based exercises as adjunctive interventions to conventional physiotherapy in children with cerebral palsy.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Elif Develi, PhD
- Telefonnummer: +90 555 593 6293
- E-Mail: elifstn@yahoo.com
Studienorte
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Istanbul, Türkei (türkiye)
- Metin Sabancı İlköğretim Okulu
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Diagnosed with cerebral palsy, including diplegic, hemiplegic, or dyskinetic types
- Gross Motor Function Classification System level I, II, or III
- Aged between 6 and 12 years
- Having sufficient cognitive ability to understand and follow simple verbal instructions
- Voluntary participation in the study with legal guardian consent
Exclusion Criteria:
- Gross Motor Function Classification System level IV or V
- Spasticity level of 2 or higher in target muscle groups according to the Modified Ashworth Scale
- Botulinum toxin injection within the last 6 months
- Orthopedic or neurological surgery affecting motor function within the last 6 months
- History of uncontrolled epilepsy or neurological conditions contraindicating virtual reality applications
- Severe visual or hearing impairment that may prevent participation in the study
- Concurrent participation in another rehabilitation program during the study period
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Sensory-Motor Integration-Based Exercise Program
Participants in this group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. The program will target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The intervention will be delivered for 16 weeks, two sessions per week. |
A structured sensory-motor integration-based exercise program targeting postural control, balance, motor planning, sensory processing, body awareness, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The program will be administered in addition to standard conventional physiotherapy.
Andere Namen:
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Aktiver Komparator: Virtual Reality-Based Exercise Program
Participants in this group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. The program will provide visual and auditory feedback in a game-based environment and will aim to improve motivation, task-oriented movement repetition, balance, and functional motor performance. The intervention will be delivered for 16 weeks, two sessions per week. |
A Nintendo Wii Sports-based virtual reality exercise program using visual and auditory feedback in a game-based environment to support motivation, task-oriented movement repetition, balance, and functional motor performance. The program will be administered in addition to standard conventional physiotherapy.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Gross Motor Function Measure Dimensions D and E Score
Zeitfenster: Baseline and week 17
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Gross motor function will be assessed using the Gross Motor Function Measure, dimensions D and E. The assessment will evaluate standing, walking, running, and jumping-related gross motor abilities in children with cerebral palsy. |
Baseline and week 17
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Change in Pediatric Balance Scale Score
Zeitfenster: Baseline and week 17
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Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance. |
Baseline and week 17
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Change in Timed Up and Go Test Performance
Zeitfenster: Baseline and week 17
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Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Shorter completion time indicates better functional mobility. |
Baseline and week 17
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in ABILHAND-Kids Score
Zeitfenster: Baseline and week 17
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Upper extremity and hand function in daily activities will be assessed using the ABILHAND-Kids questionnaire completed with parent or caregiver report. |
Baseline and week 17
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Change in Hand Grip Strength
Zeitfenster: Baseline and week 17
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Hand grip strength will be measured using a calibrated hand dynamometer according to a standardized testing position. Measurements will be performed for each hand, and the highest value will be used for analysis. |
Baseline and week 17
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Change in Physical Activity Self-Efficacy Scale for Children Score
Zeitfenster: Baseline and week 17
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Physical activity self-efficacy will be assessed using the Physical Activity Self-Efficacy Scale for Children to evaluate children's perceived confidence and ability to participate in physical activity. |
Baseline and week 17
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- YEDU-FTR-CP-SMI-VR-2026-001
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Individual participant data will not be shared due to the small sample size, pediatric population, and privacy considerations. De-identified aggregate results may be reported in scientific publications or presentations.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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