| CTRI Number |
CTRI/2025/10/096528 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
The effect of task oriented training vs. trunk stabilization exercises on trunk control and balance in subacute stroke patients: A comparative study. |
|
Scientific Title of Study
|
The effect of task oriented activities vs trunk stabilization execises to improve trunk control and balance in subacute stroke patient. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devpriya Vijay Nanadurbare |
| Designation |
Graduate |
| Affiliation |
Dr. Ulhas Patil college of physiotherapy, Jalgaon. |
| Address |
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra.
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra.
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
9356901196 |
| Fax |
|
| Email |
nandurbaredp11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chitra Mridha |
| Designation |
Professor |
| Affiliation |
Dr. Ulhas Patil college of physiotherapy, Jalgaon. |
| Address |
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra.
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra.
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
9881929503 |
| Fax |
|
| Email |
chitunkirtaniya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devpriya Vijay Nandurbare |
| Designation |
Graduate |
| Affiliation |
Dr. Ulhas Patil college of physiotherapy, Jalgaon. |
| Address |
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra.
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra.
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
9356901196 |
| Fax |
|
| Email |
nandurbaredp11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ulhas Patil college of physiotherapy, Jalgaon.
Address: NH-06, Gat No. 57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Devpriya Vijay Nandurbare |
| Address |
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra, India. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Devpriya Vijay Nandurbare |
Dr. Ulhas Patil college of physiotherapy, Jalgaon |
NH-06,Gat No.57 1, Khirdi Shivar, Tal and Dist-Jalgaon, Pincode-425001, Maharashtra, India.
Jalgaon
MAHARASHTRA |
09356901196
nandurbaredp11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Dr. Ulhas Patil college of physiotherapy, Jalgaon. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I67||Other cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Task oriented training |
Task oriented training-
Supine shoulder flexion.
Reaching for objects placed above in supine.
Trunk side flexion in sitting.
Forward reaching in sitting.
Extend the knee at hip level in sitting and making circle.
Pick up the ball from table in sitting.
Chair marching in sitting.
Bend forward and mark on table.
Bend down and pick up an object from floor.
Sit to stand.
Step up and step down with or without support.
One session per day, five days in a week for four weeks.
|
| Intervention |
Trunk stabilization execises |
Trunk stabilization exercises-
Abdominal drawing-in maneuver.
Upper trunk rotation in supine.
Lower trunk rotation in supine.
Bridging.
Pelvic anteversion retroversion in supine.
Upper trunk rotation in sitting.
Lower trunk rotation in sitting.
Trunk flexion-extension in sitting.
Trunk inclination in sitting.
Lift hemipelvis in sitting.
One session per day, five days in a week for four weeks.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 45 and above.
Patient with subacute phase(from 3 months after stroke untill 6 months).
Male and female both included.
Berg balance scale score more than 21.
MMSE score more than 24.
Patient is able to sit with or without support.
|
|
| ExclusionCriteria |
| Details |
Musculoskeletal conditions affecting trunk movement.
Other neurological diseases or orthopedic impairments.
Trunk impairment scale score greater than or equal to 10.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg balance scale (BBS)
Trunk impairment scale (TIS)
|
4 weeks
|
|
|
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)
|
07/11/2025 |
| 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="4"
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
|
Aim - To compare the effect of task oriented training vs trunk stabilization exercises on trunk control and balance in subacute stroke patients.
Objectives - 1. To find the effect of task oriented training on trunk control and balance in subacute stroke patients. 2. To find the effect of trunk stabilization exercises on trunk control and balance in subacute stroke patients. 3. To compare the effect of task oriented training and trunk stabilization exercises on trunk control and balance in subacute stroke patients
Procedure - Ethical clearance will be taken from institutional ethics committee of DR. ULHAS PATIL COLLAGE OF PHYSIOTHERAPY prior to the commencement of study. A comparative study will be carried out at multispeciality hospitals. Participants shall be selected based on conclusion and exclusion criteria. First, the nature and purpose of study will be explain to the participants. A brief evaluation of data from all participants will be conducted and written consent will be taken from the participants. A subject will be evaluated by the Berg Balance Scale, Trunk Impairment Scale, MMSE. Group A will be receive task oriented training and group B will be receive trunk stabilization exercises. Post treatment evaluation by berg balance scale, trunk impairment scale. Data analysis and result. Statistical data will be done by unpaired t-test
Interventin protocol - Group A - Task Oriented Training Supine shoulder flexion with cane Reaching for object placed above in supine Trunk side flexion in sitting Forward reaching in sitting Reaching for object placed beside them Extend the knee at hip level in sitting Extend the knee at hip level and make a circle in sitting Pick up the ball from table In sitting Chair marching in sitting Bend forward and mark on the table Bend down and pick up an object from floor Sit to stand Step up and step down with or without support
Group B - Trunk stabilization exercises Abdominal drawing-in maneuver Upper trunk rotation in supine Lower trunk rotation in supine Bridging Pelvic anteversion-retroversion in supine Upper trunk rotation in sitting Lower trunk rotation in sitting Trunk flexion-extension in sitting Trunk inclination in sitting Lift hemipelvis in sitting. |