Effect of Vojta Therapy on Upper Extremity Function of Children With Cerebral Palsy

September 21, 2024 updated by: Sivaporn Vongpipatana, Mahidol University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Nonthaburi, Thailand, 11120
        • Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
  • 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
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.
No Intervention: control group
- got the ADL and kinetic activities training 30 minutes, 3 times/week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (before) and within 1 week after the final treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
active range of motion of upper extremity
Time Frame: Baseline (before) and within 1 week after the final treatment
the children was asked to active move their shoulder, elbow and wrist for measurement
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
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
3D motion analysis of upper extremity
Time Frame: Baseline (before) and within 1 week after the final treatment
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
Video recording
Time Frame: Baseline (before) and within 1 week after the final treatment
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.
Baseline (before) and within 1 week after the final treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinect sensor
Time Frame: 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.
The Kinect sensor evaluation of both upper extremities during playing computer game. Children will be asked to move their upper extremities according to game instructions: arm abduction/adduction, arm forward flexion/extension and elbow flexion/extension. During playing the computer game, there is a kinect sensor to detect motion of upper extremities and capture motion of movement in terms of range of motion, angle of movement in 3 dimensions and velocity of movements. while children playing game, there are recording of the movement via 3D motion analysis from gait lab. The parameters from Kinect sensor will be compared to the parameters which are recorded from the gait lab.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

SRI International
Srisangwan School
the royal patronage of crippled children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 21, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2023/780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

after data collection

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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