| CTRI Number |
CTRI/2024/10/075818 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| 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
|
Impact of Pelvic Proprioceptive Neuromuscular Facilitation on Balance, Stability, and Quality of Life in Chronic Stroke Survivors: A Randomized Controlled Trial
|
|
Scientific Title of Study
|
Effect of pelvic proprioceptive neuromuscular facilitation on balance , postural sway and quality of life in chronic stroke patients : A Randomised control 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 |
PRIYA MAHTO |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
PHYSIOTHERAPY OPD E-BLOCK GALGOTIAS UNIVERSITY SECTOR 17-A GREATER NOIDA UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9289497252 |
| Fax |
|
| Email |
Priya.mahto@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DIVYANSHI |
| Designation |
MPT STUDENT |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
PHYSIOTHERAPY OPD E-BLOCK GALGOTIAS UNIVERSITY SECTOR 17A GREATER NOIDA UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7678268531 |
| Fax |
|
| Email |
thakurdivynshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divyanshi |
| Designation |
MPT student |
| Affiliation |
galgotias university |
| Address |
Room No.E003, Department of physiotherapy, school of allied health sciences Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 , India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7678268531 |
| Fax |
|
| Email |
thakurdivynshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University Plot No 2, Sector 17A,Opposite Buddha International Circuit, Greater Noida Uttar Pradesh India, 203201 |
|
|
Primary Sponsor
|
| Name |
research and developmental cell galgotias university |
| Address |
Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Priya Mahto |
Department of Physiotherapy |
Room No.E 003, Department of physiotherapy, school of allied health sciences Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 , India
Gautam Buddha Nagar
UTTAR PRADESH |
9289497252
Priya.mahto@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental research committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G988||Other disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Controlled group |
Conventional exercises for Balance [reaching toward an object across the table while standing with symmetrical weight distribution over both legs, standing on a wobble board, forward walking, backward walking, obstacle crossing, walking on an uneven surface, stair climbing and walking on a ramp. ] for 30 mins , 6 times a week till 4 weeks and for Postural sway [ lifting head and chest , lifting arms and legs alternately across in supine position , lifting trunk ,lifting trunk with one leg flexion and extension alternatively ,pushing arm and leg alternately ,lifting both legs , contracting deep muscle transverse abdominis , lifting leg alternately in prone position ] will be applied to the subjects for 30 mins , 6 times a week till 4 weeks |
| Intervention |
Experimental group - |
Pelvic PNF applied to the subjects for 30 mins,6 times a week till 4 weeks.
Techniques include rhythmic initiation, slow reversal, and stabilizing reversals . |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females included
Subject who can sit independently
Subject with stages 4-5 on Brunnstrom grading
Subject capable of following commands
Subject can stand 20sec unsupported with observation
|
|
| ExclusionCriteria |
| Details |
Cognitive dysfunction
Recent spine and lower limb surgeries
Severe cardiovascular disorder
Severe respiratory disorder
Fixed deformities or contractures in the spine and lower limb
Recent spine or lower limb fractures or dislocations
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Balance
Postural sway
|
Baseline
Immediate after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline
Immediate after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/11/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study titled “Effect of Pelvic Proprioceptive
Neuromuscular Facilitation (PNF) on Balance, Postural Sway, and Quality of Life
in Chronic Stroke Patients: A Randomised Controlled Trial†aims to evaluate the
therapeutic impact of pelvic PNF
interventions on balance, postural sway, and overall quality of life in
individuals suffering from chronic stroke. Stroke patients frequently
experience impaired balance and postural instability, leading to difficulties
in performing daily activities and a reduction in their quality of life. This
trial proposes the use of pelvic PNF techniques, which involve rhythmic initiation
, slow reversal, stabilizing reversals designed to enhance neuromuscular
control and proprioception. The research hypothesizes that targeted pelvic PNF
may significantly improve balance, reduce postural sway, and enhance overall
physical and mental well-being in chronic stroke survivors. The study will
recruit eligible participants with chronic stroke, randomly assigning them to
either an intervention group receiving pelvic PNF exercises or a control group
undergoing conventional exercises. The primary outcomes to be measured include
balance (using Berg Balance Scale), postural sway (through sway meter), and
quality of life (balance evaluation system test ). Assessments will be conducted
at baseline and post-intervention phases. This research aims to provide
clinical evidence for the incorporation of pelvic PNF into stroke
rehabilitation protocols to improve functional recovery and patient
quality of life. |