CTRI

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CTRI Number

CTRI/2025/03/083381 [Registered on: 25/03/2025] Trial Registered Prospectively

Last Modified On:

17/03/2025

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

Trunk Stabilization Exercises for Stroke patients to improve hand function

Scientific Title of Study

Effect of Trunk Stabilization Exercises on Trunk balance and Upper Extremity function in patients with stroke

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Tibin Sebastian
Designation	PG Student
Affiliation	Yenepoya Physiotherapy College
Address	Yenepoya Physiotherapy College. Naringana, Deralakatte Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA 575018 India Arackaparambil (H), Thidanad P.O Pin : 686123 Kottayam KERALA 686123 India
Phone	09074009030
Fax
Email	28285@yenepoya.edu.in

Details of Contact Person
Scientific Query

Name	Lourdhuraj I
Designation	Principal
Affiliation	Yenepoya Physiotherapy College
Address	Yenepoya Physiotherapy College Yenepoya Deemed to be University Mangalore, Derelekatte 575018 Yenepoya Physiotherapy College Yenepoya Deemed to be University Mangalore, Derelekatte 575018 Dakshina Kannada KARNATAKA 575018 India
Phone	9940529169
Fax
Email	lourdhuraj4@gmail.com

Details of Contact Person
Public Query

Name	Lourdhuraj I
Designation	Principal
Affiliation	Yenepoya Physiotherapy College
Address	Yenepoya Physiotherapy College Yenepoya Deemed to be University Mangalore, Derelekatte 575018 Yenepoya Physiotherapy College Yenepoya Deemed to be University Mangalore, Derelekatte 575018 Dakshina Kannada KARNATAKA 575018 India
Phone	9940529169
Fax
Email	lourdhuraj4@gmail.com

Source of Monetary or Material Support

Physiotherapy Department Yenepoya Physiotherapy College Mangalore

Primary Sponsor

Name	Tibin Sebastian
Address	Yenepoya Physiotherapy College Yenepoya deemed to be university Mangalore, 575018
Type of Sponsor	Other [Self ]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Tibin Sebastian	Yenepoya Physiotherapy College	Physiotherapy Unit, 4th Floor Ayush Block, Yenepoya Deemed to be University, Naringana Campus, Mangalore Dakshina Kannada KARNATAKA	9074009030 28285@yenepoya.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Yenepoya Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G968\|\|Other specified disorders of central nervous system,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conventional Physiotherapy	Warm up (Stretching, breathing, active or assisted active movements of arm and legs), Mat activities including turning of trunk, trunk rotation, prone on elbow or hand, quadruped or kneeling, half kneeling to sitting and standing, strengthening isometric exercises of back and abdomen, sitting and standing balance, Cool down (Stretching, breathing, active or assisted active movements of arm and legs)
Intervention	Trunk Stabilization Exercises & Conventional Physiotherapy	Week 1: Abdominal Bracing, Trunk rotation, Knee flexion to Chest Week 2: Abdominal Bracing, Bridging, Abdominal Curls, Quadruped exercise Week 3&4: Abdominal Bracing, Bridging & Abdominal Curls on Swiss Ball, Quadruped Exercise and Seated with balance on Swiss Ball Warm up (Stretching, breathing, active or assisted active movements of arm and legs), Mat activities including turning of trunk, trunk rotation, prone on elbow or hand, quadruped or kneeling, half kneeling to sitting and standing, strengthening isometric exercises of back and abdomen, sitting and standing balance, Cool down (Stretching, breathing, active or assisted active movements of arm and legs)

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 1-6 months Subjects with Brunnstrom stage of 2 and above Subjects with an age of 45-65 years of any sex Subjects who are able to understand and follow verbal commands Subjects who are able to stand with or without support Subjects who are able to walk independently at least 10m distance

ExclusionCriteria

Details

Subjects with any musculoskeletal, cardiovascular or other neurological problems
Subjects with any visual or auditory problems

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Case Record Numbers

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
1. Trunk Impairment Scale 2. Action Research Arm Test	Pre Test Zero Week Post Test after 4 weeks

Secondary Outcome

Outcome	TimePoints
Not Applicable	Pre Test & Post Test

Target Sample Size

Total Sample Size="36"
Sample Size from India="36"
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)

04/04/2025

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="4"
Days="15"

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

This study is intended to find the effect of trunk stabilization exercises on Trunk balance and upper extremity function in patients with stroke using experimental and control group. For both groups conventional therapy will be given whereas experimental group will be additionally treated with trunk stabilization exercises. The outcomes of the study will be assessed by trunk impairment scale and Action research arm test to measure the scores of Trunk balance and upper extremity function respectively.