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Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy

14. juli 2026 opdateret af: Ibadat International University, Islamabad
This was a RCT to determine and compare the effects of vestibular stimulation in addition to conventional physical therapy on gross motor function and mobility in children with spastic diplegic cerebral palsy.

Studieoversigt

Detaljeret beskrivelse

In this RCT , Experimental Group received Vestibular Stimulation along with Conventional therapy. Control Group received Conventional physiotherapy alone.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

58

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • KPK
      • Mansehra, KPK, Pakistan, 25000
        • Ibadat International University, Islamabad

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

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • • Participants with age limit of 6-12 years

    • Diagnosed cases of Spastic Diplegic Cerebral Palsy by Pediatric neurologist
    • Both genders (male/female)
    • Participants with GMFCS Level I-III
    • Participants with Grade I spasticity, Modified Ashworth Scale (MAS) • Participants able to understand and follow basic commands.

Exclusion Criteria:

  • • Children with history of vestibular disorders, epileptic fits or uncontrolled seizures from past six months

    • Children with any surgical procedure of the spine or lower limbs or Botox treatment in the last 6 months
    • Children with any visual or hearing impairment
    • Children having any fixed deformity, contracture or fracture limiting participation in therapy
    • Patients having VP shunt

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: Experimental Group A received Vestibular Stimulation along with Conventional therapy.
Participants in this group received Vestibular Stimulation along with Conventional therapy.
Experimental Group A received Vestibular Stimulation along with Conventional therapy. Vestibular stimulation included Multi-directional swinging , Trampoline jumps , Rocking movement , Gaze stabilization exercises , Visual pursuit exercises , Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.
Aktiv komparator: Control Group B received Conventional physiotherapy alone.
Participants in this group received Conventional physiotherapy alone
Control Group B received Conventional physiotherapy alone which includes Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gross Motor Function Measure (GMFM-88)
Tidsramme: Assessment was performed at baseline and after 6 weeks of intervention.

Gross Motor Function Measure (GMFM-88) will be used to assess the progression of gross motor function over time in cerebral palsy affected children. The original GMFM version has 88-items and divided into five dimensions. each item scored on a 4-point ordinal scale of 0 to 3, where:

  • 0 shows that the participant does not begin the activity
  • 1 show that the participant initiates the activity (completes < 10% of the activity)
  • 2 show that the participant completes the activity partially (performed from 10 to 99% of the activity)
  • 3 show that the participant finishes the activity (100%)
  • NT show that the participant was not tested For each item, maximum of three trials is permitted and the best one will be recorded.

Scores for each group are expressed as a percentage of the its highest score and the total score is calculated by summing the percentage scores for each of the five groups/dimensions.

Assessment was performed at baseline and after 6 weeks of intervention.
10-Meter Walk Test (10MWT)
Tidsramme: Assessment was performed at baseline and after 6 weeks of intervention
The 10 Meter Walk Test was used to determine functional mobility in children with spastic diplegic cerebral palsy. The test will be conducted on a 14 m pathway, including the starting and ending points, with a 2 m walk-in section. The time taken to reach the midpoint of the 10 m walk will be recorded.
Assessment was performed at baseline and after 6 weeks of intervention
Timed Up and Go (TUG) test
Tidsramme: Assessment was performed at baseline and after 6 weeks of intervention.

Mobility of children was evaluated via timed get up and go (TUG) test and its results were recorded.(15) In this test, the duration of standing up from an armchair, walking up to 3 m, turn walk back, and sitting on the chair was measured. (16) Interpretations are as follow:

  • <10 seconds = normal
  • < 20 seconds = good mobility, can go out alone, mobile without a gait aid.
  • < 30 seconds = problems, cannot go outside alone, requires a gait aid.
Assessment was performed at baseline and after 6 weeks of intervention.

Samarbejdspartnere og efterforskere

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

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)

11. januar 2026

Primær færdiggørelse (Faktiske)

30. juni 2026

Studieafslutning (Faktiske)

3. juli 2026

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IIUI/RERC/ADT/2026/01/215

Plan for individuelle deltagerdata (IPD)

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