| CTRI Number |
CTRI/2024/07/071558 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of balance in post-menopausal women with dynamic neuromuscular stabilization |
|
Scientific Title of Study
|
Effect of dynamic neuromuscular stabilization on balance in post -menopausal women |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashita Chand |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block,Basement Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8279554428 |
| Fax |
|
| Email |
prashichand05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niraj Kumar PT |
| Designation |
Professor (PhD SPAHS) |
| Affiliation |
Shri Guru Ram Rai University School of paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block,Basement Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashita Chand |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block,Basement Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8279554428 |
| Fax |
|
| Email |
prashichand05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University School, of Paramedical and Allied Health Sciences ,Pathribagh,Dehradun, 248001 |
|
|
Primary Sponsor
|
| Name |
Prashita Chand |
| Address |
Shri Guru Ram Rai University School, of Paramedical and Allied Health Sciences ,Pathribagh,Dehradun, 248001 |
| 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 Prashita Chand |
Shri Guru Ram Rai University,School of Paramedical and Allied Health Sciences Dehradun |
Department of physiotherapy, North block ,basement dehradun
Dehradun
UTTARANCHAL |
8279554428
prashichand05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) Shri Guru Ram Rai Institute Of Medical And Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post menopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic neuromuscular stability exercise to improve Balance in Postmenopausal Women |
Group A: will receive dynamic neuromuscular stability exercises
The group A comprised of 15 subjects who were trained dynamic neuromuscular stability exercise with the conventional exercises. DNS training protocol was implemented in 45-min sessions, three sessions per week for six weekly. These exercises have several models and different levels of training |
| Comparator Agent |
General balance exercise |
Sit to stand (Three sets: 10 repetitions)
2 Heel raise and toe raise
3 Single legs standing
4 Tandem stance
5 Walking front to back and forth
6 Lateral weight shifting, lift your arm as you shift your weight
7.Step -up without support
4. Clock reach, stand on one leg with the arm of supporting leg resting on a chair.
8.Side step walking pattern
9.Stationary marching
10.Grape vine walk
45 min session for 3 days for 6 week |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Postmenopausal women
2 Low risk fall such as berg balance scale
3 Independence in daily activities and no use of assistive devices
4.Voluntary participation in the research. |
|
| ExclusionCriteria |
| Details |
1. Musculoskeletal injuries like fracture of lower limb and spine fracture
2. Neurological disorders that affect balance (stroke, multiple sclerosis, Parkinson disease, epilepsy etc.
3. Orthopedics disorders like osteoarthritis, rheumatoid arthritis, bursitis)
4. Presence of diabetic neuropathy and nephropathy
5. History of any congenital anomalies (clubfoot, femoral anteversion)
6. Patient on cancer treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
1st day, 21st day, 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time up and go test |
1st day, 21st day, 42nd day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
09/08/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Dynamic Neuromuscular stabilization(DNS) is a revolutionary approach to movement rehabilitation and performance enhancement that draws upon the principles of developmental kinesiology. Dns aims to optimize human movement by restoring fundamental developmental patterns ingrained in our nervous system during early stages of life.
The objective is to achieve global functional improvement, enhance trunk stability crucial for movement and balance, and ensure sustained enhancements in function and pain alleviation. These improvements are essential for facilitating everyday activities and promoting long term independence |