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Shock Wave and Spastic Cerebral Palsy Equines Foot (CP)

5. april 2021 opdateret af: Hatem Abd Elmohsen Abdel Hamid Emara, Taibah University

Effects Of Extracorporeal Shock Wave On Spastic Equines Foot In Children With Hemiplegic Cerebral Palsy

A double-blind randomized controlled study was carried out on 34 children (19 boys and 15 girls) in the age ranged from 7 to 9 years old with spastic hemiplegia were randomly allocated to one of two groups: control or study group. The two groups received traditional therapeutic exercises for 12 weeks. Additionally, study group received rESW (one session/week) on gastrocnemius and soleus muscles (1500 shots/muscle, frequency of 4Hz, energy of 0.030 mJ/mm2). All children were evaluated at baseline, and after 12 weeks by Modified Ashworth Scale, Biodex system 4 isokinetic dynamometer, Gross Motor Function Measure (GMFM-88), dimensions "D" standing and "E" walking, Trost Selective Motor Control Test, and Single Leg Standing Test.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Both groups underwent conventional physical therapy program which included muscle stretching, strengthening exercises, neurodevelopmental techniques, proprioceptive training, and balance and gait training for three months (3 days/week ,1 hour/day).

Study group Subjects in this group received the traditional physical therapy treatment plus true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week) of shock wave intervention. The pressure pulses were focused on the muscle belly of the planter flexor hypertonic muscles. Standard ultrasonic gel was used as a contact medium. A total of 1500 shots with a pressure of 1.5 bar and an energy flux density (EFD) of 0.030 mJ/mm2 were applied with the repetition frequency of shock wave irradiation of 4 pulses per second (Hz). The rESW session lasted about 6 minutes and was painless; thus, local anesthesia was not required.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Saudi Arabien
      • Al Madīnah, Saudi Arabien, 42353
        • Taibah University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 år til 9 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 1) children who could walk independently or with assistive devices ,2) children with motor dysfunction graded as a 1 or 2 on the Gross Motor Function Classification System (GMFCS), 3) children scoring 1or1+ on the Modified Ashworth Scale (MAS), 4) Dynamic ankle contracture which was confirmed if ankle equinus was observed during ambulation and passive dorsiflexion of the ankle could be accomplished beyond the neutral position with knee extended

Exclusion Criteria:

  • 1) children older than 9 years or younger than 7 years, 2) previous botulinum toxin type A injection in the gastrocnemius muscle or serial casting of the ankle within 6 months prior to enrollment, 3) fixed ankle contracture, and 4) surgery of the lower limbs in the past 12 months.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: study group
received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training plus shock wave on the muscle belly of the planter flexor hypertonic muscles.
Enhed: shock wave
true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week)
Andet: traditional physical therapy program
lower limbs muscles stretch and strength in addition to balance and gait training
Andet: control group
received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training .these traditional therapy had been approved by previous studies its effectiveness in management cerebral palsy child
Andet: traditional physical therapy program
lower limbs muscles stretch and strength in addition to balance and gait training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biodex system
Tidsramme: 12 weeks
The Biodex system 4 (Biodex Medical, Shirley, NY, USA) was used for the quantitative biomechanical assessment of the spasticity of the affected side ankle plantar flexor muscle
12 weeks
The modified Ashworth scale
Tidsramme: 12 weeks
The modified Ashworth scale, which is a six-point ordinal scale for grading (0, 1, 1+, 2, 3, and 4) was applied for clinical assessment of spasticity of ankle plantar flexors.
12 weeks
Single Leg Standing Test (SLS)
Tidsramme: 12 weeks
The SLS is a simple and effective test to assess static balance. It is conducted by measuring the time that a child can maintain balance by lifting the foot according to the signal "Start." The average of three measures was used.
12 weeks
The Trost Selective Motor Control test (TSMC)
Tidsramme: 12 weeks
The TSMC test was used to assess ability of the child to perform isolated movement of the ankle.
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taibah University

Efterforskere

  • Ledende efterforsker: hatem emaraa, PHD, Taibah University,saudi arabia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2021

Primær færdiggørelse (Faktiske)

30. marts 2021

Studieafslutning (Forventet)

15. maj 2021

Datoer for studieregistrering

Først indsendt

5. april 2021

Først indsendt, der opfyldte QC-kriterier

5. april 2021

Først opslået (Faktiske)

8. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • taibah university (Deanship of scintific research)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Cerebral Parese

Kliniske forsøg med shock wave

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Betingelser

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