CTRI

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CTRI Number

CTRI/2025/03/082996 [Registered on: 20/03/2025] Trial Registered Prospectively

Last Modified On:

26/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Non-randomized, Multiple Arm Trial

Public Title of Study

Comparing Effects of Otago Exercises and Caregiver Mediated Exercises in trunk control balance and function performance in chronic stroke patients.

Scientific Title of Study

The Effectiveness of Otago Exercise Program versus Caregiver Mediated Exercises on Trunk Control, balance, and Functional Performance in Patients with Chronic Stroke A comparative study

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr. Ajay Dhananjay Rajapkar
Designation	Post graduate student
Affiliation	RV College of Physiotherapy
Address	G02 Department of Neurological Physiotherapy RV College of Physiotherapy No.CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar KARNATAKA 560011 India
Phone	7738709175
Fax
Email	ajayrajapkar19@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Trapthi Kamath
Designation	Associate Professor
Affiliation	RV College of Physiotherapy
Address	G02 Department of Neurological Physiotherapy RV College of Physiotherapy No.CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar Bangalore KARNATAKA 560011 India
Phone	9743363485
Fax
Email	trapthikamath.rvcp@rvei.edu.in

Details of Contact Person
Public Query

Name	Dr Trapthi Kamath
Designation	Associate Professor
Affiliation	RV College of Physiotherapy
Address	G02 Department of Neurological Physiotherapy RV College of Physiotherapy No.CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar KARNATAKA 560011 India
Phone	9743363485
Fax
Email	trapthikamath.rvcp@rvei.edu.in

Source of Monetary or Material Support

RV College of Physiotherapy

Primary Sponsor

Name	RV College of Phyiotherapy
Address	G02 Department of Neurological Physiotherapy RV College of Physiotherapy No.CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar
Type of Sponsor	Other [nil]

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
Dr Ajay Rajapkar	RV College of Physiotherapy	G02 Department of Neurological Physiotherapy RV College of Physiotherapy No CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar Bangalore KARNATAKA	7738709175 ajayrajapkar19@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
RV Institute Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G811\|\|Spastic hemiplegia,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Care Giver Mediated Exercises	Caregiver Mediated Exercises Program Objective To improve trunk control in participants through a home based program. Methods 1. Phase 1 Lying Posture Participant lies in supine position with balance pad pillow under pelvis. Weight shifting and bridging exercises are performed for 10 repetitions. 2. Phase 2 Sitting Posture Participant sits on balance pad pillow. Weight shifts, arm lifts and standing exercises are performed for 10 repetitions. 3. Phase 3 Standing Posture Participant stands on balance pad pillow. Weight shifts arm lifts and mini squats are performed for 10 repetitions. Intervention 20 30 minutes day 5 times week for 4 weeks Follow-up through telerehabilitation phone call once a day Compliance monitored using self reported diary. Outcome Participants will be reassessed in person after 4 weeks to evaluate program effectiveness.
Intervention	Otago Exercise Program	The Otago Exercise Program a home based program will be explained to the participant once verbally and then through demonstration by the investigator after which the subject will be asked to perform it once in front of the therapist to ensure that the patient has understood the exercises. The Otago Exercise Program will consist of The subjects will be prescribed an exercise and walk program that consists of 17 exercises which include 5 strengthening exercises and 12 balance exercises Strength knee extensors knee flexors hip abductors ankle plantar flexors and ankle dorsiflexion. Balance knee bends backward walking walking and turning around sideways walking tandem stand tandem walking one leg stand heel walking toe walking backward heel toe walking sit to stand and stair walking. Along with these exercises a walking program is provided to the subjects which aims to include 30 minutes of walking 2 times a week according to the patients convenience. The home based intervention will span over 20 30 minutes day 5 times a week for 4 weeks during which follow up will be done once a day through telerehabilitation and or through phone calls. And finally compliance will be monitored using a self reported diary during OEP. After completion of 4 weeks the subjects will be reassessed in person.

Inclusion Criteria

Age From	35.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Subjects who are willing to participate as volunteers and sign the informed written consent. 2. Subjects living at home or with caregivers who are willing to participate in caregiver mediated exercises. 3. Individuals with chronic stroke. 4. Age group 35 to 60 years old. 5. Sufficient cognitive ability to participate as indicated by Montreal Cognitive Assessment more than 26. 6. Berg Balance Scale medium fall risk

ExclusionCriteria

Details

1. Caregiver strain index more than
2. Any other neurological or rheumatic disorders.
3. Recent spinal or lower limb surgeries.
4. Any spinal or limb deformities.
5. Uncontrolled hypertension
6. Lower extremity fractures
7. Amputation of lower extremity
8. Vestibular Disorders

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Trunk Impairment Scale Berg Balance Scale Barthel index	Pre and Post intervention

Secondary Outcome

Outcome	TimePoints
Montreal Cognitive Assessment Scale Berg Balance Scale Caregiver strain index	Pre intervention

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

22/03/2025

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="0"
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 study compares the effectiveness of the Otago Exercise Program (OEP) and Caregiver-Mediated Exercises (CME) on trunk control, balance, and functional performance in individuals with chronic stroke. Stroke often results in motor impairments affecting balance and mobility, increasing fall risks. OEP is a home-based fall prevention program focusing on strength and balance, while CME involves caregivers assisting in rehabilitation. The study aims to determine which method yields better functional improvements. Using a non-randomized comparative study design, 60 participants will be assessed pre- and post-intervention using standardized scales. Findings may enhance stroke rehabilitation strategies and inform clinical practice.