Cerebral PalsyNCT06203366
Effect of Vojta Therapy on Upper Extremity Function of Children With Cerebral Palsy
A study testing Vojta therapy in people with Cerebral Palsy and Upper Extremity, run by Mahidol University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cerebral Palsy, Upper Extremity, Vojta Therapy
- What is being tested?
- Vojta therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 15 Nov 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother
Nonthaburi, 11120
About this study
Official title: Effect of Vojta Therapy on Upper Extremity Function of Children With Cerebral
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
Read the detailed 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.
- Conditions
- Cerebral Palsy, Upper Extremity, Vojta Therapy
- Being tested
- Vojta therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Vojta therapy |
| control group | No intervention | - got the ADL and kinetic activities training 30 minutes, 3 times/week for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (before) and within 1 week after the final treatment
Secondary outcomes (4)
active range of motion of upper extremity
the children was asked to active move their shoulder, elbow and wrist for measurement
Measured: Baseline (before) and within 1 week after the final treatment
Nine hole peg test
the children have to pick 9 pegs from the container to insert into the providing holes and record the time
Measured: Baseline (before) and within 1 week after the final treatment
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.
Measured: Baseline (before) and within 1 week after the final treatment
Video recording
The camera video will record the distance of maximum reaching in forward reaching and lateral reaching during the 3D kinematics evaluation in the gait lab of both upper extremities movement. This outcome was done in only the intervention group who received Vojta treatment.
Measured: Baseline (before) and within 1 week after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Nov 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Srisangwan School, SRI International, the royal patronage of crippled children
- Responsible party
- Principal investigator, Sivaporn Vongpipatana, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203366
- Sponsor's protocol ID
- MURA2023/780
- Status last verified
- Sep 2024
- First submitted
- 30 Nov 2023
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 16108461Sadowska 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.
PubMed 32606703Prusmetikul 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
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.
PubMed 29524797Kara 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.
PubMed 31514564Sirindhorn 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.
PubMed 31658070Khiewcham 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.
PubMed 24409030Matic-Tec.de, S.R.| Therapie, Vojta. Available at: https://www.vojta.com/de/vojta-prinzip/vojtatherapie (Accessed: February 15, 2023).
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vojta Therapy on Upper Extremity Function of Children With Cerebral
- ClinicalTrials.gov ID
- NCT06203366
- Acronym / sponsor ID
- MURA2023/780
- Conditions
- Cerebral Palsy, Upper Extremity, Vojta Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Srisangwan School, SRI International, the royal patronage of crippled children
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Vojta therapy* 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 |
| control group | No intervention | –- got the ADL and kinetic activities training 30 minutes, 3 times/week for 8 weeks |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vojta therapyVojta 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. | Procedure or surgery | Experimental group |
Primary outcome
Box and block test
Time frame: Baseline (before) and within 1 week after the final treatment
the children have to pick the 1"*1" cube blocks from one side of the box to the other side in 1 minute
4 secondary outcomes
active range of motion of upper extremity
Time frame: Baseline (before) and within 1 week after the final treatment
Nine hole peg test
Time frame: Baseline (before) and within 1 week after the final treatment
3D motion analysis of upper extremity
Time frame: Baseline (before) and within 1 week after the final treatment
Video recording
Time frame: Baseline (before) and within 1 week after the final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 16108461Bax 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.
- Background: PubMed 32606703Sadowska 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.
- BackgroundPrusmetikul 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: PubMed 29524797Peeters 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.
- Background: PubMed 31514564Kara 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.
- BackgroundSirindhorn National Medical Rehabilitation Centre. Vojta therapy in childhood. Bangkok: Department of Medical Services, Ministry of Public Health; October 2556.
- Background: PubMed 31658070Sung 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.
- BackgroundKhiewcham 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: PubMed 24409030Lim 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.
- BackgroundMatic-Tec.de, S.R.| Therapie, Vojta. Available at: https://www.vojta.com/de/vojta-prinzip/vojtatherapie (Accessed: February 15, 2023).
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta therapy in people with Cerebral Palsy and Upper Extremity, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and block test (time frame: Baseline (before) and within 1 week after the final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203366, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.