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Trial registered on ANZCTR
Registration number
ACTRN12624001027505
Ethics application status
Approved
Date submitted
14/06/2024
Date registered
26/08/2024
Date last updated
26/08/2024
Date data sharing statement initially provided
26/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Intensive Segmental Trunk Training Versus Vojta Therapy in Children with Spastic Diplegic Cerebral Palsy.
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Scientific title
Effect of Intensive Segmental Trunk Training and Vojta Therapy on Clinical and Functional outcomes in children with Spastic Diplegic Cerebral Palsy
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Secondary ID [1]
312346
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy
334116
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Condition category
Condition code
Neurological
330790
330790
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm I will receive Intensive Segmental Trunk Training (ISTT), including therapeutic exercises of selective trunk segments, core stability exercises, functional reaching activities and weight shift training. Trunk exercise program will consist of 3 sets of 10-15 repetitions/day (50 min), 5 days/week for 3 consecutive months (50 hours for 60 days approx.) along with Conventional therapy.
Following treatment will be performed by physical therapist one to one. Mainly the setting will be Pediatric Rehabilitation Department of the University of Lahore Teaching Hospital, and home plan will also be provided.
The patient's guardian will have to make videos of the sessions performed at home so that the compliance and adherence to the treatment program can be checked.
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Intervention code [1]
328834
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Rehabilitation
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Comparator / control treatment
Arm II will receive Vojta Therapy (VT) which is a dynamic neuromuscular treatment based on the principles of locomotion. It is divided into two phases that are reflex creeping and reflex rolling in different starting positions. Reflex turning 1 targets the chest area in supine position, Reflex turning 2 stimulates global reactions in side lying position, Reflex creeping stimulates the forward positioning along with the global reactions in prone positioning. Different positions are applied for 8-10 minutes for 45 minutes/day, 5 days/week for 3 months and also the conventional treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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postural alignment/postural sway will be assessed as a composite outcome.
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Assessment method [1]
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Global postural system
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Timepoint [1]
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baseline, 12th week, 3 months post-treatment
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Primary outcome [2]
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Trunk control on segmental basis
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Assessment method [2]
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Segmental Assessment of Trunk Control
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Timepoint [2]
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baseline, 12th week, 3 months post-treatment
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Primary outcome [3]
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Gross motor Function
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Assessment method [3]
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Gross Motor Function Measure-88
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Timepoint [3]
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baseline, 12th week, 3 months post-treatment
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Secondary outcome [1]
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Reaching
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Assessment method [1]
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Seated Postural & Reaching Control
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Timepoint [1]
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baseline, 12th week, 3 months post-treatment
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Secondary outcome [2]
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Quality of Life
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Assessment method [2]
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Cerebral Palsy Quality of Life
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Timepoint [2]
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baseline, 12th week, 3 months post-treatment
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Secondary outcome [3]
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Functional abilities
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Assessment method [3]
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Functional Mobility Scale Version 2
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Timepoint [3]
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baseline, 12th week, 3 months post-treatment
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Eligibility
Key inclusion criteria
1. Children 4-12 years of age, both sexes, diagnosed with Spastic diplegic Cerebral Palsy.
2. Level III-V on Gross Motor Function Classification System (GMFCS)
3. Spasticity degree ranging grade 1-2 on Modified Ashworth Scale (MAS)
4. Level of segmental trunk control will be level 3 on Segmental Assessment of Trunk Control (SATCo)
5. Impaired trunk and poor postural control
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Minimum age
4
Years
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Acute fever
2. Inflammatory disease
3. Contracture or structural vertebral deformities inhibiting vertical posture
4. Undergone recent surgery, or modification in the medicinal treatment for motor function in the last 6 month-period
5. History of ataxia, dystonia, dystrophy or spina bifida affecting motor and physical performance
6. Uncontrolled seizures
7. Major visual or auditory impairments
8. Taking any other treatments
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Researcher will use sealed, numbered and opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequentially numbered, opaque, sealed envelope
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A sample size of forty-eight will be taken for this study. Based on the undermentioned assumptions the sample size needed for the study is 42 patients with 14 children in each of the three groups. We will add 2 subjects in each group, to compensate for dropout. A minimum power of 80% is acceptable in most literatures. The sample size calculation was done using sample size calculator keeping level of significance 95% and standard deviation of 4.87 in treatment group and 5.6 in control group.
Fischer’s exact test will be used for categorical responses. Shapiro-Wilk test will be used to check the normality of data. Multiple Comparison Test will be used to check the differences in group means. For within group follow-up, Friedman Test will be used. Data will be analyzed using SPSS-27.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
24/05/2024
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Date of last participant enrolment
Anticipated
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Actual
27/06/2024
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Date of last data collection
Anticipated
7/12/2024
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Actual
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment outside Australia
Country [1]
26379
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Pakistan
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State/province [1]
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Punjab
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Dr. Iqra Khan
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Address [1]
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Country [1]
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Pakistan
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Primary sponsor type
Individual
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Name
Dr. Iqra Khan
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Address
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Country
Pakistan
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Secondary sponsor category [1]
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None
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Name [1]
318957
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Address [1]
318957
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Country [1]
318957
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Lahore Research Ethical committee
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Ethics committee address [1]
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1-km, Defence Road, Near Bhuptian Chowk, Lahore, 54000, Punjab, Pakistan
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Ethics committee country [1]
315518
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Pakistan
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Date submitted for ethics approval [1]
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04/05/2024
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Approval date [1]
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22/05/2024
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Ethics approval number [1]
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REC-UOL-/206/08-24
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Summary
Brief summary
The primary objective of this study will be to evaluate the comparative effect of Intensive Segmental Trunk Training and Vojta Therapy on Postural Control. Hypothesis: Intensive Segmental Trunk Training will be more effective than Vojta Therapy in attaining postural control in terms of trunk control, sitting and upper extremity functions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Iqra Khan
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Address
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The University of Lahore, 1-km, Defence Road, Near Bhuptian Chowk, Lahore, 54000
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Country
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Pakistan
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Phone
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+923354671744
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Iqra Khan
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Address
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The University of Lahore, 1-km, Defence Road, Near Bhuptian Chowk, Lahore, 54000.
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Country
134955
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Pakistan
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Phone
134955
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+923354671744
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Fax
134955
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Email
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[email protected]
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Contact person for scientific queries
Name
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Iqra Khan
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Address
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The University of Lahore, 1-km, Defence Road, Near Bhuptian Chowk, Lahore, 54000
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Country
134956
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Pakistan
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Phone
134956
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+923354671744
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Fax
134956
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Email
134956
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data related to underlying results, without personal identification, of the individual will be shared on demand.
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When will data be available (start and end dates)?
Immediately following publication and with no end date.
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Available to whom?
Researchers who will provide a reason with proposal of their study.
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Available for what types of analyses?
To achieve the aims in approved proposal
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How or where can data be obtained?
The datasets generated during and/or analysed during the current study will be available upon request from Dr. Iqra Khan, PT, with email address:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23896
Ethical approval
387974-(Uploaded-14-06-2024-22-36-18)-REC.pdf
23897
Informed consent form
387974-(Uploaded-14-06-2024-22-38-13)-CONSENT FORM.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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