| CTRI Number |
CTRI/2025/12/098477 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Neck and Pelvic PNF Exercises on Sitting Balance in Patients with Recent Stroke: A Randomized Study |
|
Scientific Title of Study
|
Effect of neck and pelvic proprioceptive neuromuscular facilitation training on dynamic sitting control among acute stroke population. 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 |
Nishantha |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Room no: 603, 6th floor, Yenepoya physiotherapy college, Naringana mangaluru
Room no: 603, 6th floor, Yenepoya physiotherapy college, Naringana mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9620328521 |
| Fax |
|
| Email |
37879@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Anjana S |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Room no: 603, 6th floor, Yenepoya physiotherapy college, Naringana mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6363924912 |
| Fax |
|
| Email |
anjanas@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs. Anjana S |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Roon no: 603, 6th floor, Yenepoya physiotherapy college, Naringana mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6363924912 |
| Fax |
|
| Email |
anjanas@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nishantha |
| Address |
Yenepoya physiotherapy college, Naringana, Mangaluru-575108, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishantha |
Yenepoya Ayuredic Medical College Hospital |
Room no: 3, 4th floor, Physiotherapy department, Yenepoya Ayuredic Medical College Hospital, Naringana, Mangalore, 575018, Karnataka, India
Dakshina Kannada
KARNATAKA |
9620328521
37879@yenepoya.edu.in |
| Dr Nishantha |
Yenepoya Medical College Hospital |
Room no: 5, 2nd floor, medicine department, Yenepoya Medical College Hospital Deralakatte, 575018, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA |
9620328521
37879@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committe 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Conventional therapy will include breathing exercises, stretching, assisted limb movements, trunk rotation activities, pelvic bridging, bedside sitting training, and upper limb weight-bearing activities. These exercises aim to improve trunk activation, postural control, and functional sitting balance. Each session lasts 30 minutes, delivered 4 days per week for 4 weeks. |
| Intervention |
Neck and Pelvic Proprioceptive Neuromuscular Facilitation (PNF) Training |
Participants in the intervention group will receive 15 minutes of Neck and Pelvic PNF training after 30 minutes of conventional physiotherapy, totaling 45 minutes per session.
Neck PNF exercises include patterns of flexion, extension, lateral flexion, and rotation in sitting. Pelvic PNF exercises include rhythmic initiation, slow reversal, and stabilizing reversal techniques performed in side-lying, focusing on anterior elevation and posterior depression of the pelvis.
Sessions will be conducted 4 times per week for 4 weeks (16 sessions total). |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed clinically as first onset of unilateral stroke with duration of within 1month with acute stroke
Subjects with Brunnstrom stage of 2 to 4 included
Subjects with an age of 45 to 65 years of both gender
Subjects who are able to understand and follow verbal commands
Participants must be able to maintain a sitting position without hand support for at least 10 seconds. |
|
| ExclusionCriteria |
| Details |
Presence of other neurological conditions that could interfere with study outcomes.
Relevant psychiatric conditions that may prevent participants from following instructions or adhering to the study protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk Impairment Scale (TIS) total score |
4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Function In Sitting Test (FIST) score |
4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/12/2025 |
| 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="1"
Months="6"
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 purpose of this randomised controlled trial is to assess the effectiveness of neck and pelvic proprioceptive neuromuscular facilitation (PNF) training in improving dynamic sitting balance in acute stroke patients. Participants will be randomly assigned to one of two groups: an intervention group that will get neck and pelvic PNF exercises in addition to traditional physiotherapy, and a control group that will receive only conventional therapy. The study hypothesises that neck and pelvic PNF training will significantly improve trunk stability and sitting balance compared to conventional therapy alone, as evaluated by the Trunk Impairment Scale (TIS) and the Function in Sitting Test (FIST) during a four-week period. |