Effect of Sensory Integration on Gross and Balance on Children With Down Syndrome
Effect of Sensory Integration on Gross Motor Function and Balance in Children With Down Syndrome
To investigate the effect of sensory integration on gross motor function in children with Down syndrome.
To investigate the effect of sensory integration on balance in children with Down syndrome.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study will be delimited to:
- sixety children with Down syndrome, ranging in age from3 to 5 years.
- Children will be divided randomly into two groups of equal number: Control group (Group A) will receive designed physical therapy program and study group (Group B) will receive the same designed physical therapy exercises in addition to sensory integration program.
- All children will be assessed by Gross Motor Function Measure Scale (GMFM-88) and HUMAC balance system before and after the intervention.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: raheel sanad, doctoral
- Telefonnummer: 01018263304
- E-post: raheelsanad90@gmail.com
Studiesteder
-
-
-
Cairo, Egypt, 02
- Rekruttering
- Abo EL resh hospital
-
Ta kontakt med:
- raheel sanad, master
- Telefonnummer: 01018263304
- E-post: raheelsanad90@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- All children diagnosed as Down syndrome, according to genetic lab reports.
- Their age ranges from 3to 5 years.
- Both genders will be included.
- They are able to stand alone.
- They are able to follow instructions. Their IQ ranges from 65 to 80, according to Stanford Binet Intelligence Scale).
- They had been referred by sensory integration problems (low registration and seeking behavior).
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following:
- Persistent heart disease.
- Severe cognitive impairments.
- Recent surgical interference in the lower limbs.
- Obese children (BMI > 95).
- Patients with hip subluxation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: CONTROLLED GROUP
Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months
|
Participants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months. Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation |
|
Eksperimentell: STUDY GROUP
Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months.
|
Participants in the controlled group will receive a designed physical therapy program for 60 minutes,three times per week ,for 3 months. Participants in the study group will receive a designed physical therapy program for 30 minutes followed by a sensory integration program for 30 minutes,three times per week for 3 months. the designed physical therapy will include balance and strengthening exercises on the other hand sensory integration program will include different textured surfaces, vistebular stimulation |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system
Tidsramme: 3 monthes
|
balance will be assessed by the results of stability score of the Clinical Test of Sensory Interaction on Balance (CTSIB ) using HUMAC Balance system the stability score will be recorded at four conditions 1_child stand on stable surface with open eye 2_child stand on stable surface with closed eye 3_ child stand on foam surface with open eye 4_ child stand on foam surface with closed eye
|
3 monthes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
gross motor function will be assessed by Gross motor function measurement-88 scale
Tidsramme: 3 monthes
|
The motor function skills of all children in the study will be measured by Gross Motor Function Measurement-88 scale which is a criterion based observational measure.
Standing and walking dimensions only will be selected to be tested
|
3 monthes
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Raheel _SI_2025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Participations who meet the eligibility criteria will be allocated by simple randomization via sealed opaque envelopes into two matched groups by an independent person:
• Group A (control group): Children in this group will receive designed physical therapy program for 60 minutes, 3 times per week for 3 months Group B (study group): Children in this group will receive the same designed physical therapy exercises for 30 minutes and sensory program for other 30 minutes three times per week for 3 months
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .