- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07646951
Aquatic Therapy Versus Sensory Room Intervention for Sensory-Motor Function in Children With Sensory Processing Disorder (AQUA vs SRI Tr)
Comparative Impact of Aquatic Therapy and Conventional Sensory Room Intervention on Adaptive Neural Responses and Sensory-Motor Praxis in Children With Monochannel Sensory Processing Disorder: A Randomized Clinical Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Monochannel sensory processing disorder refers to a condition where a child tends to rely heavily on a single sensory channel-usually visual, auditory, or tactile-while ignoring or underutilizing others. This limited sensory integration can negatively affect the child's ability to interact with the environment, learn effectively, and develop age-appropriate motor and cognitive skills. Children with monochannel processing often struggle with transitions, emotional regulation, and tasks requiring multi-sensory coordination. Aquatic therapy is a powerful therapeutic intervention that uses the unique properties of water-such as buoyancy, hydrostatic pressure, resistance, and temperature-to create a multisensory environment that enhances motor control, body awareness, attention, and sensory integration. These qualities make it particularly effective for children with sensory processing difficulties. Aquatic therapy supports sensory processing by stimulating multiple sensory systems simultaneously. For example, the pressure of the water provides deep proprioceptive input, movement through water enhances vestibular feedback, and water temperature activates tactile receptors. This simultaneous multisensory input can help children shift from single-sense reliance to more integrated, adaptive responses.
60 children diagnosed with monochannel sensory processing disorder, aged 4-8 years (both sexes) Two equal groups: Intervention group (Aquatic therapy) and Control group (Sensory room therapy), 30 children each.
Two equal groups: Intervention group (Aquatic therapy) and Control group (Sensory room therapy), 30 children each.
Inclusion Criteria:
Children aged 4-8 years with a confirmed diagnosis of monochannel sensory processing disorder.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following conditions:
- Medical Instability: Any acute illness, fever, or infectious diseases (e.g., ear infections or open wounds) that contraindicate pool therapy.
- Neurological Risks: Children with uncontrolled seizures or epilepsy that poses a safety risk in an aquatic environment.
- Severe Phobia: Extreme fear of water (hydrophobia) that prevents active participation in aquatic exercises.
- Recent Surgery: Any recent surgical interventions (orthopedic or neurological) that have not yet reached full clinical clearance for physical activity.
- Incontinence: Severe lack of bowel or bladder control unless specific medical swim diapers are utilized according to facility policy.
Measuring Tools:
To evaluate the transition from monochannel reliance to multi-sensory integration, the following standardized tools will be utilized:
- Sensory Processing Measure (SPM-2): Used to assess multi-sensory integration across different environments (home and school) and provide a total sensory systems score.
- Evaluation of Ayres Sensory Integration (EASI): Employed to measure adaptive neural responses, sensory perception, and motor planning (praxis).
- Sensory Integration and Praxis Tests (SIPT): A comprehensive diagnostic battery used to evaluate the relationship between sensory processing and motor behavior in depth.
Procedure (brief outline):
1. Evaluation procedures: Pre-treatment assessment of sensory integration and processing abilities to each group.
Group A: Aquatic Therapy Intervention (Experimental Group) The aquatic program utilizes the physical properties of water (buoyancy, hydrostatic pressure, and resistance) to provide multi-sensory input.
Group B: Conventional Sensory Room Therapy (Control Group) This group receives land-based sensory integration therapy in a standard clinical setting.
- Primary Outcome: Significant improvement in the Total Sensory Systems Score (SPM-2), indicating a shift from monochannel reliance to effective multi-sensory integration.
- Secondary Outcomes: Enhanced Adaptive Neural Responses and sensory perception as measured by EASI, and improved Sensory-Motor Praxis and coordination as quantified by SIPT
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Children aged 4-8 years with a confirmed diagnosis of monochannel sensory processing disorder.
Exclusion Criteria:
- Medical Instability: Any acute illness, fever, or infectious diseases (e.g., ear infections or open wounds) that contraindicate pool therapy.
- Neurological Risks: Children with uncontrolled seizures or epilepsy that poses a safety risk in an aquatic environment.
- Severe Phobia: Extreme fear of water (hydrophobia) that prevents active participation in aquatic exercises.
- Recent Surgery: Any recent surgical interventions (orthopedic or neurological) that have not yet reached full clinical clearance for physical activity.
- Incontinence: Severe lack of bowel or bladder control unless specific medical swim diapers are utilized according to facility policy.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Aquatic Therapy Group
Participants will receive aquatic therapy sessions as the sole intervention.
The program aims to improve motor function, balance, muscle tone regulation, and upper limb coordination in children with spastic cerebral palsy.
Outcomes will be assessed before and after the intervention period.
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Participants will receive aquatic therapy sessions conducted in a therapeutic pool under the supervision of a licensed physical therapist.
The program will focus on improving sensory-motor integration, postural control, balance, muscle tone regulation, and functional motor skills in children with sensory processing disorder.
Sessions will be delivered multiple times per week over a specified intervention period, with individualized exercises adapted to each child's abilities and therapeutic goals.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Total Sensory Systems Score (SPM-2)
Časové okno: Baseline (pre-intervention) and immediately after completion of the intervention period (post-intervention).
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Baseline (pre-intervention) and immediately after completion of the intervention period (post-intervention).
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Significant improvement in the Total Sensory Systems Score (SPM-2), indicating a shift from monochannel reliance to effective multi-sensory integration.
Časové okno: Baseline (pre-intervention) and immediately after completion of the intervention period (post-intervention).
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The primary outcome will be measured using the Sensory Processing Measure-2 (SPM-2).
The Total Sensory Systems Score will be assessed to evaluate changes in sensory integration abilities, specifically the shift from monochannel sensory processing to more effective multisensory integration.
Assessments will be conducted at baseline and after completion of the intervention period.
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Baseline (pre-intervention) and immediately after completion of the intervention period (post-intervention).
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RE/2111/MTI.PT/2605121
Informace o lécích a zařízeních, studijní dokumenty
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