Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000507583
Ethics application status
Approved
Date submitted
4/12/2023
Date registered
24/04/2024
Date last updated
2/09/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Dynamic Neuromuscular Stabilization (DNS) exercise in adolescent idiopathic scoliosis: A Randomized Controlled Trial
Scientific title
Investigating the Efficacy of the Dynamic Neuromuscular Stabilization Approach on Lumbopelvic Stability in Idiopathic Scoliosis: A Randomized Controlled Trial
Secondary ID [1] 311045 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adolescent idiopathic scoliosis 332255 0
Condition category
Condition code
Musculoskeletal 328973 328973 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

The experimental group will receive Dynamic Neuromuscular Stabilization (DNS) session 30 minutes, followed by core stability exercises for 30 minutes. A 10-minute warm-up and cool-down will be provided before and after the whole session. Initially, participants received verbal cues, manual guidance, and visual feedback throughout the intervention to facilitate the learning process of adjusting the alignment of the pelvis, spine, ribcage, scapula, and abdominal wall shape in different positions. The program is divided into two phases: the first phase covers the initial three weeks and involves administering exercises DNS 1-4, while the second phase spans the concluding three weeks of the program, during which DNS 5-7 exercises will be administered. The DNS exercises will be prescribed by the DNS certified and trained physiotherapist to the participants.
The DNS exercises are as follows:
1) Deep breathing in sitting ,2) Deep breathing in supine with hip and knee at 90-90° position,3) Low quadruped,4)5-month side-lying, 5) Oblique sitting, 6) Tripod position, 7)Bear position and Squat position.
Exercise intensity based on developmental positions automatically proper activation stereotype of stabilization and breathing of natural postural-locomotion patterns as defined by developmental kinesiology. After the DNS session, the participants will be asked to remain on the training mat for 5 minutes before starting core stability exercises.

The overall intervention will be carried out in the form of a one-to-one session for each participant for a total of 12 weeks.. All participants will be required to carry out the DNS and a set of home exercise programs such as core stability exercises, postural correction exercises are prescribed by physiotherapists for one 60 minute session for two times per week during the 12 week intervention. An audio file will be given to the participants to provide verbal cue for them while doing the DNS program during home program. To monitor the participants’ compliance, they will be requested to record and mark the dates of their home program on a log sheet during the research period.
Intervention code [1] 327551 0
Rehabilitation
Comparator / control treatment


In control group, the participants will receive 60-minute of supervised exercise sessions per week for 12 weeks. Each session consisted of 10-minute warm up exercises, 30-minute Core stability exercise (CSE) with 30-second break after each set and correction of the participants’ exercise movement or position (total: 40 minutes) and 10-minute cool down exercises.

The CSE exercises are as follows
1.Isolated transversus abdominis training,
2. Isolated lumbar multifidus training,
3. Supine pelvic bridging,
4. Co-contraction of transversus abdominis and lumbar multifidus in quadruped position,
5. Four-point multifidus exercise
6 . Full front plank,
7. Full front plank with abduction of lower extremities,
8. Half side plank with knees flexed,
9. Tall kneeling lift with medicine ball,
10. Half-kneeling chop with TheraBand

The participants will be instructed to maintain each exercise position in both phases for 10-12 seconds, 3 sets with 10 repetitions each set. The participants will be receiving first-five CSE in the first phase and progress to another five exercises in second phase. In the first session, the participants will be train on how to perform isolated activation of transversus abdominis muscle while executing an abdominal drawing-in technique. After understanding and mastering the abdominal drawing-in maneuver, the participants will be instructed to execute it during all CSE, accompanied with normal breathing.
A home exercises program template will be given to the participants. The participants will be required to carry out the same exercises prescribed during the supervised exercise sessions at home on the days without supervised program.
To monitor the participants’ compliance, they will be requested to record and mark the dates of their home program on a log sheet during the research period.
Control group
Active

Outcomes
Primary outcome [1] 336760 0
Lumbopelvic stability
Timepoint [1] 336760 0
Participants will be evaluated twice at baseline and 13th weeks post-commencement of treatment
Secondary outcome [1] 429609 0
The spatiotemporal parameters of gait and pelvic angles,and this will be evaluated as a combined result.
Timepoint [1] 429609 0
Participants will be evaluated twice at baseline and 13th weeks post-commencement of treatment

Eligibility
Key inclusion criteria
• Males and Females
• Age between 18 to 25 years old
• Individuals with idiopathic scoliosis
• Not using any brace
• Voluntary participation
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of surgical correction of the spine.
• Currently receiving other exercise for scoliosis.

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)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed-mode ANOVA

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/07/2024
Actual
16/07/2024
Date of last participant enrolment
Anticipated
30/08/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
15
Final
Recruitment outside Australia
Country [1] 26018 0
Malaysia
State/province [1] 26018 0
Selangor

Funding & Sponsors
Funding source category [1] 315303 0
University
Name [1] 315303 0
UNIVERSITIT TUNKU ABDUL RAHMAN
Country [1] 315303 0
Malaysia
Primary sponsor type
University
Name
UNIVERSITIT TUNKU ABDUL RAHMAN
Address
Sungai Long Campus Jalan Sungai Long, Bandar Sungai Long Cheras 43000, Kajang, Selangor
Country
Malaysia
Secondary sponsor category [1] 317350 0
None
Name [1] 317350 0
Address [1] 317350 0
Country [1] 317350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314227 0
UTAR Scientific and Ethical Review Committee
Ethics committee address [1] 314227 0
Ethics committee country [1] 314227 0
Malaysia
Date submitted for ethics approval [1] 314227 0
26/01/2024
Approval date [1] 314227 0
10/07/2024
Ethics approval number [1] 314227 0
U/SERC/56(B)-29/2024

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

Contacts
Principal investigator
Name 130858 0
A/Prof Dr Deepak Thazhakkattu Vasu
Address 130858 0
M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long City Campus, Jalan Sungai Long, Bandar Sungai Long, Cheras, 43000 Kajang, Selangor, MALAYSIA.
Country 130858 0
Malaysia
Phone 130858 0
+60390860288
Fax 130858 0
Email 130858 0
[email protected]
Contact person for public queries
Name 130859 0
Dr Deepak Thazhakkattu Vasu
Address 130859 0
M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long City Campus, Jalan Sungai Long, Bandar Sungai Long, Cheras, 43000 Kajang, Selangor, MALAYSIA.
Country 130859 0
Malaysia
Phone 130859 0
+60390860288
Fax 130859 0
Email 130859 0
[email protected]
Contact person for scientific queries
Name 130860 0
Dr Deepak Thazhakkattu Vasu
Address 130860 0
M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Sungai Long City Campus, Jalan Sungai Long, Bandar Sungai Long, Cheras, 43000 Kajang, Selangor, MALAYSIA.
Country 130860 0
Malaysia
Phone 130860 0
+60390860288
Fax 130860 0
Email 130860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Gait parameters will be shared
When will data be available (start and end dates)?
Immediately following publication and available for 5 years after publication
Available to whom?
other researchers
Available for what types of analyses?
metanalysis
How or where can data be obtained?
To obtain access, please contact the principal investigator via email at [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



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.