- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07785011
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: raheel sanad, doctoral
- Telefonnummer: 01018263304
- E-Mail: raheelsanad90@gmail.com
Studienorte
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Cairo, Ägypten, 02
- Rekrutierung
- Abo EL resh hospital
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Kontakt:
- raheel sanad, master
- Telefonnummer: 01018263304
- E-Mail: raheelsanad90@gmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
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 |
|---|---|
|
Experimental: 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 |
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Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
balance measured by Stability Score of the Clinical Test of Sensory Interaction on Balance(CTSIB) using HUMAC Balance system
Zeitfenster: 3 monthes
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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
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3 monthes
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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gross motor function will be assessed by Gross motor function measurement-88 scale
Zeitfenster: 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
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3 monthes
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
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
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Raheel _SI_2025
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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