| CTRI Number |
CTRI/2025/09/094536 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2026 |
| 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
|
Can Core Exercises Improve Balance and Muscle Control After a Stroke? |
|
Scientific Title of Study
|
Effect of Trunk Rehabilitation Exercises on Muscle Tonicity and Functional Reach Among Patients with Acute Post-Stroke. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi S |
| Designation |
Post Graduation Student |
| Affiliation |
Yenepoya Physiotherapy College Mangalore |
| Address |
Department of Physiotherapy,
Yenepoya Physiotherapy College,
Room No. 603, 6th floor Neuroscience Division,
University Road, Deralakatte,
Mangalore, Dakshina Kannada District,
Karnataka, India – 575018.
Tel: 0824-2206000
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7339099290 |
| Fax |
|
| Email |
vaishnavi.suraj4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Lourdhuraj I |
| Designation |
Principal |
| Affiliation |
Yenepoya Physiotherapy College Mangalore |
| Address |
Department of Physiotherapy,
Yenepoya Physiotherapy College,
Room No 1, 6th floor Neuroscience Division,
University Road, Deralakatte,
Mangalore, Dakshina Kannada District,
Karnataka, India – 575018.
Tel: 0824-2206000
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi S |
| Designation |
Post Graduation Student |
| Affiliation |
Yenepoya Physiotherapy College Mangalore |
| Address |
Department of Physiotherapy,
Yenepoya Physiotherapy College,
Room No. 603, 6th floor Neuroscience Division,
University Road, Deralakatte,
Mangalore, Dakshina Kannada District,
Karnataka, India – 575018.
Tel: 0824-2206000
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7339099290 |
| Fax |
|
| Email |
vaishnavi.suraj4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Ayurveda Medical Hospital,
Naringana, Mangalore,
Dakshina Kannada District,
Karnataka, India – 575018 |
| Yenepoya Medical College Hospital,
University Road, Deralakatte,
Mangalore, Dakshina Kannada District,
Karnataka, India – 575018 |
|
|
Primary Sponsor
|
| Name |
Vaishnavi S |
| Address |
University Road, Deralakatte, Mangalore 575018, Karnataka, India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Lourdhuraj I |
University Road, Deralakatte, Mangalore 575018, Karnataka. Phone: 9940529169 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lourdhuraj I |
Yenepoya Ayurveda Medical College Hospital |
Room no 2, 4th floor Out-Patient Department of Physiotherapy and Occupational Therapy
Dakshina Kannada
KARNATAKA |
9940529169
lourdhuraj4@gmail.com |
| Dr Lourdhuraj I |
Yenepoya Medical College Hospital |
Room no 1, 7th floor Out-Patient Department of Physiotherapy and Occupational Therapy
Dakshina Kannada
KARNATAKA |
9940529169
lourdhuraj4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Participants in the control group will receive conventional physiotherapy focusing on range of motion, mobility, and functional training. Each session lasts 30 minutes, conducted 4 times per week for 2 weeks. |
| Intervention |
Conventional Physiotherapy + Trunk Rehabilitation Exercises |
Participants in the experimental group will receive a combination of conventional physiotherapy and trunk rehabilitation exercises to improve trunk stability, balance, and functional reach. Each session lasts 45 minutes (30 minutes conventional physiotherapy + 15 minutes trunk rehabilitation), conducted 4 times per week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with acute stroke (within more than 24hrs to 2 weeks postonset).
2.Both male and female patients aged 30–70 years.
3.Patients with a Modified Ashworth Scale (MAS) rating of 1+.
4.Patients in Brunnstrom Stages II-V for Upper Limb and Lower Limb recovery.
5.Patients with a MMSE score more than or equal to 24, indicating mild cognitive impairment but adequate ability to follow instructions for rehabilitation.
6.Patients who can provide informed consent or have a caregiver who can provide consent on their behalf. |
|
| ExclusionCriteria |
| Details |
1.Patients with a history of recurrent stroke or multiple strokes.
2.Patients with other neurological disorders (e.g Parkinson’s disease, multiple sclerosis).
3.Comorbidities that contraindicate exercise therapy (e.gsevere cardiac conditions, uncontrolled hypertension).
4.Patients with orthopedic conditions affecting the spine, pelvis, or lower limbs that limit participation in trunk rehabilitation exercises.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Tardieu Scale: Used to assess spasticity by measuring the muscle response to passive stretch at three different speeds (0 to 4), and the angle of muscle catch is measured using a goniometer. Higher scores indicate greater spasticity.
2. Functional Reach Test: Assesses dynamic balance and fall risk. The participant reaches forward while standing without moving the feet. The distance reached indicates better balance and postural control. The final score is the average of three trials.
|
1. Tardieu Scale: Baseline (pre-intervention) and after 2 weeks of intervention.
2. Functional Reach Test: Baseline (pre-intervention) and after 2 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| Date of Study Completion (India) |
04/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/05/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This randomized controlled trial aims to assess the effect of trunk rehabilitation exercises on muscle tonicity and functional reach in acute post-stroke patients. A total of 36 participants will be randomly assigned to two groups one receiving conventional physiotherapy alone, and the other receiving additional trunk rehabilitation exercises. Muscle tone will be measured using the Modified Tardieu Scale, and functional reach will be assessed using the Functional Reach Test. The intervention will last for two weeks, with four sessions per week. The study seeks to determine whether targeted trunk exercises can enhance postural control and functional ability during early stroke recovery. |