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Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome

8 april 2022 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

8 år till 10 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Children ages will be ranged from 8 to 10 years old.
  2. Functional hearing and vision.
  3. 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)
  4. Independent standing and walking.

Exclusion Criteria:

  1. Synptomatic pain.
  2. Musculoskeletal problems or/ atlanto-axial instability.
  3. Rheumatic and congenital heart disease
  4. History of previous surgical operation
  5. Regular participation in any sport activities.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Designed Physical Therapy Program
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.
Experimentell: 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.
Övrig: Designed Physical Therapy Program
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.
Övrig: Whole-Body Vibration

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.
Experimentell: 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.
Övrig: Designed Physical Therapy Program
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.
Övrig: Gravity Force Stimulation

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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postural Stability
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Mobility
Tidsram: Up to 12 weeks
Six-minute walk test will be used for measuring functional mobility. It is a sub-maximal test of aerobic capacity, in which the subjects walk as far as possible in 6 minutes (min.) around a premeasured distance
Up to 12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beni-Suef University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

9 april 2022

Primärt slutförande (Förväntat)

9 juli 2022

Avslutad studie (Förväntat)

9 juli 2022

Studieregistreringsdatum

Först inskickad

8 april 2022

Först inskickad som uppfyllde QC-kriterierna

8 april 2022

Första postat (Faktisk)

15 april 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P.T.REC/012/003598

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Downs syndrom

Kliniska prövningar på Designed Physical Therapy Program

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