Trial Review

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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.
Scientific title
Effect of Intensive Segmental Trunk Training and Vojta Therapy on Clinical and Functional outcomes in children with Spastic Diplegic Cerebral Palsy
Secondary ID [1] 312346 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 334116 0
Condition category
Condition code
Neurological 330790 330790 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328834 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 338551 0
postural alignment/postural sway will be assessed as a composite outcome.
Timepoint [1] 338551 0
baseline, 12th week, 3 months post-treatment
Primary outcome [2] 338552 0
Trunk control on segmental basis
Timepoint [2] 338552 0
baseline, 12th week, 3 months post-treatment
Primary outcome [3] 338553 0
Gross motor Function
Timepoint [3] 338553 0
baseline, 12th week, 3 months post-treatment
Secondary outcome [1] 436427 0
Reaching
Timepoint [1] 436427 0
baseline, 12th week, 3 months post-treatment
Secondary outcome [2] 436428 0
Quality of Life
Timepoint [2] 436428 0
baseline, 12th week, 3 months post-treatment
Secondary outcome [3] 436429 0
Functional abilities
Timepoint [3] 436429 0
baseline, 12th week, 3 months post-treatment

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
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Researcher will use sealed, numbered and opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequentially numbered, opaque, sealed envelope
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
24/05/2024
Date of last participant enrolment
Anticipated
Actual
27/06/2024
Date of last data collection
Anticipated
7/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 26379 0
Pakistan
State/province [1] 26379 0
Punjab

Funding & Sponsors
Funding source category [1] 316747 0
Self funded/Unfunded
Name [1] 316747 0
Dr. Iqra Khan
Country [1] 316747 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Iqra Khan
Address
Country
Pakistan
Secondary sponsor category [1] 318957 0
None
Name [1] 318957 0
Address [1] 318957 0
Country [1] 318957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315518 0
The University of Lahore Research Ethical committee
Ethics committee address [1] 315518 0
Ethics committee country [1] 315518 0
Pakistan
Date submitted for ethics approval [1] 315518 0
04/05/2024
Approval date [1] 315518 0
22/05/2024
Ethics approval number [1] 315518 0
REC-UOL-/206/08-24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134954 0
Dr Iqra Khan
Address 134954 0
The University of Lahore, 1-km, Defence Road, Near Bhuptian Chowk, Lahore, 54000
Country 134954 0
Pakistan
Phone 134954 0
+923354671744
Fax 134954 0
Email 134954 0
[email protected]
Contact person for public queries
Name 134955 0
Iqra Khan
Address 134955 0
The University of Lahore, 1-km, Defence Road, Near Bhuptian Chowk, Lahore, 54000.
Country 134955 0
Pakistan
Phone 134955 0
+923354671744
Fax 134955 0
Email 134955 0
[email protected]
Contact person for scientific queries
Name 134956 0
Iqra Khan
Address 134956 0
The University of Lahore, 1-km, Defence Road, Near Bhuptian Chowk, Lahore, 54000
Country 134956 0
Pakistan
Phone 134956 0
+923354671744
Fax 134956 0
Email 134956 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who will provide a reason with proposal of their study.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Data related to underlying results, without personal identification, of the individual will be shared on demand.

What types of analyses could be done with individual participant data?
• To achieve the aims in approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication and with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23896Ethical approval    REC.pdf
23897Informed consent form    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.