NCT06203366

Brief Summary

The goal of this pilot study is to study the effect of Vojta therpy on upper extremity function in children with cerebral palsy. The main questions are:

  • to study the effect of Vojta therapy on upper extremity function in children with cerebral palsy in terms of range of motion and function
  • to study the effect of Vojta therapy on upper extremity function in children with cerebral palsy in terms of motion analysis while perform function

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

November 30, 2023

Last Update Submit

September 21, 2024

Conditions

Cerebral PalsyUpper ExtremityVojta Therapy

Outcome Measures

Primary Outcomes (1)

  • Box and block test

    the children have to pick the 1"\*1" cube blocks from one side of the box to the other side in 1 minute

    Baseline (before) and within 1 week after the final treatment

Secondary Outcomes (4)

  • active range of motion of upper extremity

    Baseline (before) and within 1 week after the final treatment

  • Nine hole peg test

    Baseline (before) and within 1 week after the final treatment

  • 3D motion analysis of upper extremity

    Baseline (before) and within 1 week after the final treatment

  • Video recording

    Baseline (before) and within 1 week after the final treatment

Other Outcomes (1)

  • Kinect sensor

    This outcome will be measured only in the intervention group. It will be measured immediately or not longer than 1 week after finish the intervention.

Study Arms (2)

Experimental group

EXPERIMENTAL

* got the Vojta treatment 30 minutes/session, 3 times/week for 8 weeks * got the ADL and kinetic activities training 30 minutes, 3 times/week for 8 weeks

Procedure: Vojta therapy

control group

NO INTERVENTION

\- got the ADL and kinetic activities training 30 minutes, 3 times/week for 8 weeks

Interventions

Vojta therapyPROCEDURE

Vojta therapy is an old treatment method which was discovered by Professor Vaclav Vojta, a neurologist and pediatrician. It has been used to treat children with impair motor function in Thailand since 2011. Vojta therapy encourage the movement of children via positioning and stimulate the specified zone.

Experimental group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • spastic diplegia (MACS II-III)
  • can pick box and block test at least 1 block
  • has good trunk stability while sitting
  • can follow command
  • participant and guardian consent to the study

You may not qualify if:

  • no Vojta therapy in last 2 months
  • no history of anti-spastic injection in last 6 months
  • do not receive prednisolone nor adrenocorticotropic hormone (ACTH)
  • cannot control seizure
  • got the specific disease such as osteogenesis imperecta, cardiac disease
  • Participant and guardians do not consent to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother

Nonthaburi, 11120, Thailand

Location

Related Publications (10)

  • Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.

    PMID: 16108461BACKGROUND

  • Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.

    PMID: 32606703BACKGROUND

  • Prusmetikul S, Vongpipatana S, Woratanarat P, Tuntiyatorn P, Tamonsawatruk T. Correlation of range of motion and functional performance of upper extremities in children with cerebral palsy. J Med Assoc Thai 2018;101;Suppl.3

    BACKGROUND

  • Peeters LHC, de Groot IJM, Geurts ACH. Trunk involvement in performing upper extremity activities while seated in neurological patients with a flaccid trunk - A review. Gait Posture. 2018 May;62:46-55. doi: 10.1016/j.gaitpost.2018.02.028. Epub 2018 Mar 6.

    PMID: 29524797BACKGROUND

  • Kara OK, Yardimci BN, Sahin S, Orhan C, Livanelioglu A, Soylu AR. Combined Effects of Mirror Therapy and Exercises on the Upper Extremities in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial. Dev Neurorehabil. 2020 May;23(4):253-264. doi: 10.1080/17518423.2019.1662853. Epub 2019 Sep 13.

    PMID: 31514564BACKGROUND

  • Sirindhorn National Medical Rehabilitation Centre. Vojta therapy in childhood. Bangkok: Department of Medical Services, Ministry of Public Health; October 2556.

    BACKGROUND

  • Sung YH, Ha SY. The Vojta approach changes thicknesses of abdominal muscles and gait in children with spastic cerebral palsy: A randomized controlled trial, pilot study. Technol Health Care. 2020;28(3):293-301. doi: 10.3233/THC-191726.

    PMID: 31658070BACKGROUND

  • Khiewcham P., Vongpipatana S., Wongphaet P., Thipsook K. Effect of Vojta Therapy on Gait of Children with Cerebral Palsy. J Thai Rehabil Med 2016; 26(3): 91-97

    BACKGROUND

  • Lim H, Kim T. Effects of vojta therapy on gait of children with spastic diplegia. J Phys Ther Sci. 2013 Dec;25(12):1605-8. doi: 10.1589/jpts.25.1605. Epub 2014 Jan 8.

    PMID: 24409030BACKGROUND

  • Matic-Tec.de, S.R.| Therapie, Vojta. Available at: https://www.vojta.com/de/vojta-prinzip/vojtatherapie (Accessed: February 15, 2023).

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 30, 2023

First Posted

January 12, 2024

Study Start

November 15, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

For the study protocol and informed consent, they will be shared to all of the researchers. for the study protocol, SAP, ICF,CSR and analytic code, they will he shared to Chananchida Widchayasart and Parit Wongphaet after finishing data collection.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
after data collection

Locations

TH(1)