| CTRI Number |
CTRI/2024/07/070660 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Improving Balance and Mobility After Stroke: Comparing Trunk PNF Exercises to Core Stabilization |
|
Scientific Title of Study
|
Effectiveness of Trunk PNF Exercises vs Core Stabilization Exercises on Trunk Control, Balance, and Mobility in Stroke Patients: A Randomized Clinical 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 |
Silpa N P |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Institute Of Physiotherapy , Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar,Mangalore,Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8891082758 |
| Fax |
|
| Email |
silpanp17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Thrishala Noronha |
| Designation |
Associate Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar,Mangalore, Dakshina Kannada
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9743201400 |
| Fax |
|
| Email |
thrish22.cp@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Silpa N P |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Institute of Physiotherapy , Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University,Pandeshwar, Mangalore,Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8891082758 |
| Fax |
|
| Email |
silpanp17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Physiotherapy Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar,Mangalore, Dakshina Kannada,Karnataka 575001 |
| 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 |
| Silpa N P |
Institute of Physiotherapy, Srinivas University |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University,Pandeshwar, Mangalore
Dakshina Kannada
KARNATAKA |
8891082758
silpanp17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core stabilization exercises |
Core stabilization exercises divided into 2 phases. In phase 1 the exercises will be done seated on a stable surface it include, flexion and extension of the lumbar spine, lateral trunk flexion, upper trunk rotation, lower trunk rotation, forward reach in three directions. Progress to the next phase upon 30-second stability on a physioball. In phase 2 the same exercises will be given on a physioball. Core stability exercises will be given once in a day, 5 days per week for 4 weeks for 20 minutes |
| Intervention |
Trunk PNF exercises
|
The Trunk PNF exercises include,Stabilizing Reversals, Rhythmic Stabilization techniques in chopping and lifting pattern. In trunk PNF exercises will be give once in a day,5 days per week for 4 weeks for 20 minutes duration. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. First ever Stroke
2. Age 45 to 65 years
3. Both genders
4. Subjects should be able to sit unsupported for at least 20 minutes
5. Ability to walk at least 6 meters with or without assistance. |
|
| ExclusionCriteria |
| Details |
1.Patients having neurological disease other than stroke
2.Any spinal deformity
3.Uncontrolled hypertension > 140/90 mm Hg
4.uncorrected visual, sensory, or hearing impairments, and metabolic or malignant
disorders with potential emergency implications
5.MMSE score < 24
6.Any diagnosed cardiorespiratory problem
7.Recent history of trauma and recent injuries (6 months)
8.Unilateral neglect and apraxia
9.Aphasia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk impairment scale version 2.0 (TIS 2.0), modified functional reach TEST (MFRT), Time Up and go test(TUG) |
Pre intervention baseline,
Post intervention 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
25/07/2024 |
| 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="1"
Months="0"
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
|
This randomized clinical trial aims to evaluate and compare the effectiveness of Trunk Proprioceptive Neuromuscular Facilitation (PNF) exercises versus Core Stability exercises in improving trunk control, balance, and mobility among stroke patients aged 45-65. Conducted from March 2024 to July 2025, the study involves participants who are first-time stroke survivors capable of sitting unsupported for at least 20 minutes and walking a minimum of 6 meters with or without assistance. Participants, recruited through purposive sampling at Neurorehabilitation OPD and Srinivas Medical College Hospital in Mangalore, will undergo conventional physiotherapy along with specific interventions: Group A receives Trunk PNF Exercises for 20 minutes daily, 5 days a week, while Group B performs Core Stability Exercises under the same regimen. Pre- and post-intervention assessments will utilize the Trunk Impairment Scale version 2.0 (TIS 2.0), Modified Functional Reach Test (MFRT), and Time Up and Go test (TUG) to measure outcomes. This study aims to provide evidence-based insights into optimizing rehabilitation strategies for enhancing functional independence in stroke patients. |