- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07921186
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic Cerebral Palsy
To compare the effectiveness of core stability training and vestibular stimulation on sitting balance in hypotonic Cerebral Palsy
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Qamar Mehmood
- Telefonnummer: 03335151063
- E-post: qamar.mehmood@riphah.edu.pk
Studiesteder
-
-
Punjab Province
-
Chakwal, Punjab Province, Pakistan
- Rekruttering
- Helping Hand for Relief and Development
-
Ta kontakt med:
- Qamar Mehmood
- Telefonnummer: 03335151063
- E-post: qamar.mehmood@riphah.edu.pk
-
Hovedetterforsker:
- Zahra Jahan, MS-PPT
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
Age between 2-8 years.
- Clinical diagnosis of hypotonic cerebral palsy.
- Segmental assessment of trunk control - not full independent trunk control.
- Cognitive ability (who follows command)
- Medical stability
Exclusion Criteria:
Progressive neurological disorder.
- Uncontrolled epilepsy.
- Visual or hearing impairment
- Behavioral problems
- Vertigo
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Core stability and conventional
Core stability training and conventional therapy on sitting balance in Hypotonic cerebral palsy |
Basic core stability training with supine bridging, lateral weight shifting and conventional therapy with trunk facilitation. Sessions will be conducted 5 time per week for 8 weeks. Sessions lasts for 30 minutes. |
|
Aktiv komparator: Vestibular stimulation and conventional therapy
Vestibular stimulation and conventional therapy on sitting balance in hypotonic cerebral palsy |
Vestibular stimulation with gym ball and swing along with conventional therapy. Sessions will be conducted 5 time per week for 8 weeks. Sessions lasts for 30 minutes. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Segmental assessment of trunk control
Tidsramme: week 0 , week 4, week 8
|
To evaluate trunk stability and it has 7 levels. Each level consists of 3 components(static, active and reactive). Trunk stability will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pediatric Balance Scale
Tidsramme: week 0 , week 4, week 8
|
To assess static and dynamic balance. It consists of 14 items scoring from (0=unable, 1=maximal assistance , 2= moderate assistance , 3=minimal assistance). Total score is 56.Static and dynamic balance will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
|
Pediatric Evaluation of Disability inventory
Tidsramme: week 0 , week 4, week 8
|
To assess functional mobility and daily activities. it consists of 3 domains scoring from (0= child does not perform activity , 1 = child perform activity). Total functional score is 12. Functional mobility will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
|
Reaching Performance Scale
Tidsramme: week 0 , week 4, week 8
|
To assess quality of reaching movements. It has 6 components scoring from(0=no performance , 1= poor performance, 2= moderate performance, 3= good performance) Total score is 18.Quality of reaching movement will be measured baseline (0 week), mid intervention(4 weeks) and post intervention(8 weeks). |
week 0 , week 4, week 8
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Qamar Mehmood, MS, Riphah International University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
- Elshafey MA, Abdrabo MS, Elnaggar RK. Effects of a core stability exercise program on balance and coordination in children with cerebellar ataxic cerebral palsy. J Musculoskelet Neuronal Interact. 2022 Jun 1;22(2):172-178.
- Khan MZ, Khaliq S, Asim M, Mahmood NQK, Khan FA, Khan FA, et al. Impact of Vestibular Stimulation on Motor Function and Balance in Children with Hypotonic Cerebral Palsy: A Randomized Controlled Trial. Multidisciplinary Surgical Research Annals. 2025;3(2):1-7.
- Sivaramachandran R, Natarajan M. Impact of sensory perceptual motor core stability training on sitting control in children with cerebral palsy. Fisioterapia em Movimento. 2025;38:e38118.
- Parashar A, Pattnaik M, Mohanty P. Effect of vestibular stimulation versus whole body vibration on standing balance in children with spastic diplegic cerebral palsy. J Nov Physiother. 2017;7(348):2.
- Rani M, Waqas S, Asim HM, Tariq M, Javaid A. Effectiveness of Vestibular Stimulation on Balance Using Swing Therapy in Children with Hypotonic Cerebral Palsy. Annals of King Edward Medical University. 2022;28(1).
- Yılmaz DA, Yildiz M, Yildirim MS, Ozlenir M. The The effects of core stability exercises on proprioception and balance in children with hemiplegic cerebral palsy. Retos. 2023;50:1123-8
- Elbasan B, Akaya KU, Akyuz M, Oskay D. Effects of neuromuscular electrical stimulation and Kinesio Taping applications in children with cerebral palsy on postural control and sitting balance. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):49-55. doi: 10.3233/BMR-169656.
- Mohamed N, Ibrahim MB, El-Agamy OA, Aldhahi MI, Elsebahy SY. Effects of Core Stability Training on Balance, Standing, and Gait in Children with Mild Cerebral Palsy: A Randomized Controlled Trial. Healthcare (Basel). 2025 May 29;13(11):1296. doi: 10.3390/healthcare13111296.
- Aravamuthan BR, Fehlings D, Shetty S, Fahey M, Gilbert L, Tilton A, Kruer MC. Variability in Cerebral Palsy Diagnosis. Pediatrics. 2021 Feb;147(2):e2020010066. doi: 10.1542/peds.2020-010066. Epub 2021 Jan 5.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC/MS-PT/02473 Zahra Jahan
Plan for individuelle deltakerdata (IPD)
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