| CTRI Number |
CTRI/2025/03/083075 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of dynamic neuromuscular stabilization(DNS) on functional independence in adult Indian women
|
|
Scientific Title of Study
|
Effect of dynamic neuromuscular stabilization on functional independence in adult Indian women |
| Trial Acronym |
DYNEST-FI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal Rani |
| Designation |
Master of Occupational Therapy |
| Affiliation |
Jamia Hamdard |
| Address |
5th floor, occupational therapy Department, Central library, Jamia Hamdard, Mehrauli Badarpur Road, New Delhi, Delhi 110062
New Delhi
DELHI
110062
India |
| Phone |
9354773971 |
| Fax |
|
| Email |
komalmittal04032000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Noor Mohammad |
| Designation |
Assistant Professor |
| Affiliation |
Department of Occupational therapy, Jamia Hamdard |
| Address |
5th floor, occupational therapy Department, Central library, Jamia Hamdard, Mehrauli Badarpur Road, New Delhi, Delhi 110062
New Delhi
DELHI
110062
India |
| Phone |
9811745726 |
| Fax |
|
| Email |
noormohd@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Komal Rani |
| Designation |
Master of Occupational Therapy |
| Affiliation |
Jamia Hamdard |
| Address |
5th floor, occupational therapy Department, Central library, Jamia Hamdard, Mehrauli Badarpur Road, New Delhi, Delhi 110062
New Delhi
DELHI
110062
India |
| Phone |
9354773971 |
| Fax |
|
| Email |
komalmittal04032000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, Jamia Hamdard |
|
|
Primary Sponsor
|
| Name |
Komal Rani |
| Address |
5th floor, occupational therapy Department, Central library, jamia hamdard, Mehrauli Badarpur Road, New Delhi, Delhi 110062 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Noor Mohammad |
Jamia Hamdard |
room no. 11, occupational therapy unit, Rehabilitation center, Jamia Hamdard, Mehrauli Badarpur Road, New Delhi, Delhi 110062
New Delhi
DELHI |
9811745726
noormohd@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals without any comorbidity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic neuromuscular stabilization |
Dynamic Neuromuscular Stabilization (DNS) is a comprehensive rehabilitation approach developed by Professor Pavel Kolar, rooted in the principles of developmental kinesiology. It focuses on optimizing the bodys movement system by enhancing the coordination and function of intrinsic spinal stabilizers, which are crucial for maintaining core stability and overall body funct
total 8 weeks intervention will be planned, 3 sessions each week.
phase 1: basic exercises (2 weeks)
phase 2: Advanced Exercises: Higher Postural (Developmental) Positions (3 weeks)
phase 3: advanced dynamic functional positions (3 weeks)
|
| Comparator Agent |
EDUCATION |
Diaphragmatic breathing exercise, resistance exercise of larger muscle group of upper and lower extremity, aerobic activity (brisk walk) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
healthy non-athlete female,
age between 25-35 yr,
no participation in any other exercise activities during the research period,
no medically necessary restrictions to perform exercises; and,
no suffering from any untreated injury during the last 6 months before the study
|
|
| ExclusionCriteria |
| Details |
athletic female,
age below 25 and above 35 years,
pregnant female,
lactating mothers,
subject who had gone under surgery in the last 6 months,
chronic systematic disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
functional mobility
functional balance
core strength
quality of life |
baseline and after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mental health:Depression anxiety stress scale 21 |
baseline & after 8 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Functional
mobility is the ability to move freely and efficiently in daily activities.
Core strength plays a vital role in maintaining proper functional mobility.
Weak core muscles can lead to poor posture, decreased balance, and difficulty
performing movements like walking, climbing stairs, or transitioning between
positions. Functional mobility and balance are crucial components of an
individual’s quality of life. Decreased mobility and balance can lead to
reduced independence, increased risk of falls, and difficulty performing daily
tasks. This can negatively impact mental health, social interactions, and
overall well-being.
High prevalence rates of musculoskeletal disorders highlight the need for effective interventions to
address it in adult Indian women. Dynamic Neuromuscular Stabilization (DNS) can
be a promising approach to improve functional mobility, balance, core strength
and overall quality of life and reducing musculoskeletal distress by targeting
the underlying neuromuscular dysfunctions and restoring optimal movement
patterns. Hypothesis: DNS has
significant positive impact in improving functional mobility, functional
balance, core and quality of life in
young Indian women.
|