Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome
8. april 2022 oppdatert av: Eman Wagdy, Beni-Suef University
The purpose of the study is to compare the effect between of whole-body vibration and gravity force stimulation on postural stability in children with Down syndrome.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Down Syndrome (DS) is one of genetic disorders characterized by some common clinical and functional features.
Most children with Down syndrome have deficits in postural stability or balance, co-ordination, gait, and functional mobility throughout childhood and adulthood.
Postural control dysfunctions are the most common problems found in children with DS leads them to be more inactive, which contributes to functional mobility problems.
Several techniques that involve proprioceptive, vestibular, and visual inputs are so beneficial to children with DS.
Whole-body vibration (WBV) is one of the training methods that use high-frequency mechanical stimuli generated by a vibrating platform and transmitted through the body, leading to bone loading and sensory receptor stimulation.
Gravity force stimulation (GFS) has a strong impact on the child's sensory system helping to normalize the system through exercises that send strong messages to the brain to regulate the tactile, proprioceptive and vestibular components.
Hence, there is need to compare between the effects of whole-body vibration training and gravity force stimulation on postural stability in children with Down syndrome.
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Eman Wagdy
- Telefonnummer: 01008079576
- E-post: Eman.wagdy@pt.bsu.edu.eg
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 10 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Children ages will be ranged from 8 to 10 years old.
- Functional hearing and vision.
- Mild and moderate mental retardation with IQ level (50-70) determined by a psychiatric specialist in the school (IQ measured by Stanford-Binet intelligence scale)
- Independent standing and walking.
Exclusion Criteria:
- Synptomatic pain.
- Musculoskeletal problems or/ atlanto-axial instability.
- Rheumatic and congenital heart disease
- History of previous surgical operation
- Regular participation in any sport activities.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Designed Physical Therapy Program
Designed Physical Therapy Program Down syndrome children will receive the designed physical therapy program for 1 hour.
The duration of treatment will be 3 times/week for 12 weeks.
|
The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
|
|
Eksperimentell: Whole-Body Vibration
Designed physical therapy program in addition to whole-body vibration.
Down syndrome children will receive the designed physical therapy program for 1 hour in addition to whole-body vibration with an amplitude of 2 mm, vibration frequency ranged from 25 to 30 Hz and, vibration time ranged from 5 to10 minutes.
The duration of treatment will be 3 times/week for 12 weeks.
|
The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
The designed physical therapy program (mentioned before) + Whole-body vibration (WBV) training, child will be asked to stand with slightly flexed knees (30 degrees of knee flexion), and both feet will be placed at an equal distance from the center of the platform to achieve an equal distribution of body weight over both feet. The device will set to produce a peak-to-peak sinusoidal vibration with an amplitude of 2 mm and a vibration frequency ranged from 25 to 30 Hz. WBV will applied for (30 sec. of WBV, 1 min rest, 10 repetitions), (45 sec. of WBV, 1 min rest, 10 repetitions), (60 sec. of WBV, 1 min rest, 10 repetitions) in the 1st, 2nd. and 3rd. months respectively. |
|
Eksperimentell: Gravity Force Stimulation
Designed physical therapy program in addition to gravity force stimulation.
Down syndrome children will receive the designed physical therapy program for 1 hour in addition to gravity force stimulation with 10 repetitions for each position.
The duration of treatment will be 3 times/week for 12 weeks.
|
The designed physical therapy program include gentle stretching exercises, static muscle contraction, facilitation of trunk control from different positions, balance training from different positions on tilting board, facilitation of righting, protective and equilibrium reactions from different positions, facilitation of standing from different positions, gait training and, climbing stairs up and down.
The designed physical therapy program (mentioned before) + Gravity force stimulation child will be asked to maintain his balance on GFS during each of the following positions as a progression (standing and walking on the surface of two beams connecting the two boxes - standing and walking crossly on the surface of one beam connecting the two boxes - standing and walking sideward on the surface of one beam connecting the two boxes - standing and walking on the edge of the two beams - standing and walking on the edge of one beam: most difficult) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postural Stability
Tidsramme: Up to 12 weeks
|
Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
|
Up to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Funksjonell mobilitet
Tidsramme: Opptil 12 uker
|
Seks-minutters gangtest vil bli brukt for å måle funksjonell mobilitet.
Det er en sub-maksimal test av aerob kapasitet, der forsøkspersonene går så langt som mulig på 6 minutter (min.)
rundt en forhåndsmålt avstand
|
Opptil 12 uker
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
9. april 2022
Primær fullføring (Forventet)
9. juli 2022
Studiet fullført (Forventet)
9. juli 2022
Datoer for studieregistrering
Først innsendt
8. april 2022
Først innsendt som oppfylte QC-kriteriene
8. april 2022
Først lagt ut (Faktiske)
15. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/003598
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