- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05229757
The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
The activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. The effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated.
The individuals included in the study were divided into two groups as patient and control. In the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Individuals in the control group were followed up with a home program. After 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Şahinbey
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Gaziantep, Şahinbey, Tacchino, 27000
- Hasan Kalyoncu University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Be in the age range of 3-18 years.
- Getting a diagnosis of cerebral palsy.
- Agree to participate in the study.
Exclusion Criteria:
- If the child interrupts supportive education for any reason,
- Failure of the family to ensure continuity in participation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Study Group
Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks.
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Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center.
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Comparatore attivo: Control Group
Individuals in the control group were followed with a home program for 8 weeks.
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Home exercise was applied by the families every day of the week for 8 weeks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Abilhand Kids (For patients)
Lasso di tempo: Change from Baseline Abilhand Kids at 8 weeks.
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It is a questionnaire consisting of 21 questions designed to test children's manual abilities.
The applicability of the items by the child is evaluated in 3 steps as impossible, easy and difficult.
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Change from Baseline Abilhand Kids at 8 weeks.
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GMFM 66 (For patients)
Lasso di tempo: Change from Baseline GMFM 66 at 8 weeks.
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Gross motor function assessment is a computerized test consisting of 66 questions.
Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.
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Change from Baseline GMFM 66 at 8 weeks.
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PEDI (For patients)
Lasso di tempo: Change from Baseline PEDI at 8 weeks.
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It is a scale that evaluates the functional skills of the child and the help and manner of the caregiver, in which each part is evaluated separately as self-care, mobility and social function items.
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Change from Baseline PEDI at 8 weeks.
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Beck Depression Scale (For family)
Lasso di tempo: Change from Baseline Beck Depression Scale at 8 weeks.
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It is a survey aiming to reach the result by scoring between 0 and 3 with 21 questions.
According to the total score, it is divided into 4 groups as minimal, mild, moderate and severe depression.
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Change from Baseline Beck Depression Scale at 8 weeks.
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IPFAM (For family)
Lasso di tempo: Change from Baseline IPFAM at 8 weeks.
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The family impact scale asks for answers in 4 categories: I strongly disagree (4 points), disagree (3 points), agree (2 points), completely agree (1 point) in 27 questions.
Makes classification according to the total score.
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Change from Baseline IPFAM at 8 weeks.
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2021/048
Piano per i dati dei singoli partecipanti (IPD)
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Prove cliniche su Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.
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Psychiatric Research Unit, Region Zealand, DenmarkRitiratoRicovero psichiatrico
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VA Office of Research and DevelopmentReclutamentoCrisi non epilettiche psicogene (PNES)Stati Uniti