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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06203366
Other study ID # MURA2023/780
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2024
Est. completion date March 31, 2026

Study information

Verified date January 2024
Source Mahidol University
Contact Sivaporn Vongpipatana, MD.
Phone 022011154
Email sivaporn.vop@mahidol.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Vojta therapy
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.

Locations

Country Name City State
Thailand Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother Nonthaburi

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University Srisangwan School

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 active range of motion of upper extremity the children was asked to active move their shoulder, elbow and wrist for measurement Baseline (before) and within 1 week after the final treatment
Secondary Nine hole peg test the children have to pick 9 pegs from the container to insert into the providing holes and record the time Baseline (before) and within 1 week after the final treatment
Secondary 3D motion analysis of upper extremity the markers were attached at back, sternum, both shoulders, elbows and wrists. Then, children were to forward rech the object on the table. The camera and mrakers will record and analyz the motion of both upper extremities. This measurement will be done only in children who was treated with Vojta therapy group only. This measurement will report in distance of maximum reaching, velocity and angle velocitym of shoulder, elbow, wrist with forearm pronation/supination. The other parameters are movement duration, peak velocity, time to peak velocity and trajectory straigthness. Baseline (before) and within 1 week after the final treatment
Secondary Video recording The camera video will record the distance of maximum reaching in forward reaching and lateral reaching. Baseline (before) and within 1 week after the final treatment
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