| CTRI Number |
CTRI/2026/01/100107 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of 4 weeks pelvic proprioceptive neuromuscular facilitation techniques with Traditional Balance Exercise on balance, gait, and quality of life among elderly: A Randomized Control Trial |
|
Scientific Title of Study
|
Effect Of 4 Weeks Pelvic Proprioceptive Neuromuscular Facilitation Techniques With Traditional Balance Exercise On Balance, Gait, And Quality Of Life Among Elderly: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Punam Laxmanrao Nidwanche |
| Designation |
Master of Community Physiotherapy Student |
| Affiliation |
Maharashtra Institute Of Physiotherapy ,latur |
| Address |
Department Of Community Physiotherapy OPD G14,Maharashtra Institute Of Physiotherapy , MIMSR Medical Campus ,Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
7720014337 |
| Fax |
|
| Email |
punamn901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shital Ghule |
| Designation |
Associate professor of department of community physiotherapy , latur |
| Affiliation |
Maharashtra Institute Of Physiotherapy ,latur |
| Address |
Department Of Community Physiotherapy OPD G14,Maharashtra Institute Of Physiotherapy , MIMSR Medical Campus ,Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9689568795 |
| Fax |
|
| Email |
shitalphad900@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Laxmanrao Nidwanche |
| Designation |
Master of Community Physiotherapy Student |
| Affiliation |
Maharashtra Institute Of Physiotherapy ,latur |
| Address |
Department Of Community Physiotherapy OPD G14,Maharashtra Institute Of Physiotherapy , MIMSR Medical Campus ,Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
7720014337 |
| Fax |
|
| Email |
punamn901@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute Of physiotherapy,MIMSR Medical Campus, Ambajogai Road, Latur ,Maharashtra, India
413531 |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute Of Physiotherapy,Latur |
| Address |
Maharashtra Institute Of Physiotherapy, MIMSR Medical Campus, Ambajogai Road, Latur 413531 |
| Type of Sponsor |
Private medical college |
|
|
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 Punam Laxmanrao Nidwanche |
Maharashtra Institute of physiotherapy, latur |
Department Of Community Physiotherapy OPD G14,Maharashtra Institute Of Physiotherapy , MIMSR Medical Campus ,Latur
Latur
MAHARASHTRA |
07720014337
punamn901@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pelvic Proprioceptive Neuromuscular Facilitation with traditional balance exercise |
Pelvic Proprioceptive Neuromuscular Facilitation includes Following group of
exercises a)anterior elevation
b)posterior depression c)anterior depression
d)posterior elevation
traditional balance exercise
a)standing on one leg
b)tandem walking
c)cross over walking
d)figure of eight walking
e)backward and sideways walking
f)sitting balance on swiaa ball |
| Comparator Agent |
Traditional Balance Exercise |
Traditional Balance exercise include following group of exercise a)Standing on one leg b)Tandem walking c) Cross over walking d) Figure of eight walking e)Backward and Sideways walking f)sitting balance on swiss ball |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Older adults aged Above 60 years
2)Both male and female subjects
3)Willing to participate
4)Poma score between 19-24 (moderate fall risk)
|
|
| ExclusionCriteria |
| Details |
1)Severe vision impairments
2)Patients with severe, disabling arthritis.
3)Any other musculoskeletal disorder of the lower extremity.
4)Patient who did not consent to follow-up.
|
|
|
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Tinetti Performance Oriented Mobility
2.time up and go test |
baseline after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Quality of life sf-12 |
Baseline after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2026 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is to identify the Effect of 4 Weeks Pelvic Proprioceptive Neuromuscular Facilitation Techniques with traditional balance exercise with various outcome measures such as Balance, Gait, and Quality of life in elderly . all included patients will be divided into two groups.group A will receive pelvic proprioceptive neuromuscular facilitation with traditional balance exercise and group B receives traditional balance exercise . tinetti poma , time up and go and quality of life will be assessed at baseline and after 4 weeks of intervention.In both experimental and conventional group treatment protocols total duration of the session would be 35 to 40 minutes. Data will be collected by using a structure proforma. Data will be entered in an MS excel sheet and will be analyzed by using SPSS 24.0 version IBM USA. Qualitative data will be expressed in terms of proportions Quantitative data will be expressed in terms of Mean and Standard deviation.Association between two qualitative variables will be seen by using Chi-square/ Fischer’s exact test. |