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CTRI Number  CTRI/2025/07/090891 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
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   Core Exercises to Improve Posture, Balance, and Daily Activities in People recovering from stroke Recovering from Stroke. Recovering from Stroke 
Scientific Title of Study   Impact of core stability exercises on thoraco spine curvature, standing balance, and quality of life in stroke patients: A randomized controlled 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  Vaishnavi Santosh Patange 
Designation  Post Graduate Student 
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  7021197508  
Fax    
Email  vaishnavipatange1710@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa Khandare Phd 
Designation  Associate Professor 
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  8149853651  
Fax    
Email  shilpa.khandare@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Vaishnavi Santosh Patange 
Designation  Post Graduate Student 
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  7021197508  
Fax    
Email  vaishnavipatange1710@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 
 
Primary Sponsor  
Name  Vaishnavi Santosh Patange 
Address  Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune, Maharashtra 411018 
Type of Sponsor  Other [SELF FUNDED] 
 
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 Vaishnavi Santosh Patange  Dr. D. Y. Patil College of Physiotherapy OPD  OUTPATIENT DEPARTMENT (OPD), Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA 		 07021197508

vaishnavipatange1710@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise Protocol for Experimental Group A  Weeks 1 and 2: Participants will begin with core stability and functional mobility exercises. These include Pelvic Bridging, performed for 2 to 3 sets of 10 to 12 repetitions, holding each repetition for 5 seconds. The Bird Dog exercise will also be performed for 2 to 3 sets of 10 repetitions on each side, with a 5-second hold. Functional reach activities such as picking up objects from various heights (table, stool, floor) will be incorporated for 2 to 3 sets of 5 repetitions at each height to promote functional strength and balance. Balance exercises include standing with support for 2 sets of 3 minutes and marching in place for 2 sets of 30 steps, with emphasis on upright posture and trunk stability. Sitting on the edge of the bed will be practiced for 2 sets of 3 minutes to encourage postural correction, followed by standing without support for 2 sets of 2 to 3 minutes to improve static balance. Hip extension exercises in the prone position on hands will be performed for 2 to 3 sets of 10 repetitions per leg, with a 5-second hold per repetition. Bilateral straight leg raises (SLR) will be done for 2 to 3 sets of 10 repetitions with a 5-second hold for each repetition. Ambulation training includes walking forward, backward, and sideways for 3 sets of 5 minutes in each direction to enhance gait stability. Flexibility training includes hamstring and quadriceps stretches, each held for 20 to 30 seconds per leg for 2 sets. Weeks 3 and 4: Progression of exercises will include advanced core and trunk strengthening activities. Modified Side Bridge will be introduced for 2 to 3 sets of 10 to 12 repetitions, holding each for 5 to 10 seconds per side. Bird Dog will be continued for 2 to 3 sets of 10 to 12 repetitions per side with a 5-second hold. Bridge with Pullover will also be added for 2 to 3 sets of 10 repetitions, using light resistance as needed. Advanced trunk drills such as Reach Outs will be performed in both sitting and standing positions for 2 to 3 sets of 10 repetitions in each posture to improve functional core control. Weight bearing in standing will be maintained for 2 sets of 2 to 3 minutes as tolerated. Balance and proprioception training includes Tandem Stance under both eyes open and eyes closed conditions for 2 sets of 30-second holds each, and One Leg Circle in the supine position for 2 to 3 sets of 10 repetitions per leg. Standing balance exercises will include positions with hands on hips, by sides, and raised up, held for 2 to 3 sets of 30 seconds in each position, progressing towards reduced support. Walking training in forward, backward, and sideways directions will be continued and progressed to 3 sets of 5 to 7 minutes per direction. Flexibility exercises will include Hamstring and Quadriceps stretches for 2 sets of 30-second holds per leg. Total Duration of the treatment-40 minutes  
Comparator Agent  Exercise Protocol for Group B  Treatment for the group B is conventional exercise, it includes:- Sitting leg crossed, Sitting legs uncrossed Stretching for hamstring ,quadriceps, TA Range of motion exercises Tandem standing (EO,EC) Abdominal curls, Pelvic bridging Weight shifting in standing, sitting Duration-5 days a week total duration of the treatemnt-40 min 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. A diagnosed case of stroke
2. Both genders (Male and female)
4. Trunk impairment scale (10 to 20)
5 patients who can follow instructions and participate in exercise programs.
6. Affected side SLS time: less than 5 seconds (Eyes open) indicating reduced standing balance
Ability to stand unassisted on either leg for at least 3 seconds (minimum motor control required)
7. Participants will be included if they demonstrate abnormal spinal curvature and/or reduced spinal mobility as assessed by the Spinal Mouse, including thoracic kyphosis angle more than 40 degree, lumbar lordosis angle less than 30 degree, total trunk mobility (flexion and extension) less than 90 degree, or lateral flexion range less than 15° towards the affected side. These criteria ensure the presence of measurable spinal dysfunctions potentially responsive to core stability training interventions
 
 
ExclusionCriteria 
Details  1 Individual suffering from stroke along with other neurological condition like Parkinson’s
2 A Musculoskeletal related deformity
3 Individual having Recent fracture
4 Hemodynamically unstable patient
5 Visual impairment like hemi – neglect
6 Subjects with peripheral vascular diseases (e.g ranaud syndrome)
7. Medical “red flags” (eg: tumor, fracture, cervical myelopathy, rheumatoid arthritis, osteoporosis, prolonged steroid use


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Trunk Impairment Scale (TIS)
Spinal mouse
Single-leg stance scale
Stroke-specific quality of life scale (SSQOL)


 		 baseline asssesment and post intervention assesment 
 
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)   25/07/2025 
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 present randomized controlled trial is designed to evaluate the impact of core stability exercises on thoracic spine curvature, standing balance, trunk function, and quality of life among stroke patients. The study will be conducted at Dr. D.Y. Patil Hospital and Research Center, Pimpri, Pune. A total of 32 participants diagnosed with stroke will be selected using purposive sampling and randomly allocated into two groups. Group A will receive advanced trunk and balance training exercises (40 minutes, 5 repetitions × 2 sets), whereas Group B will undergo conventional physiotherapy management (25 minutes, 5 repetitions × 2 sets). The intervention will continue for 4 weeks, with progressive core stability exercises incorporated over time.

Outcome measures include thoracospinal curvature (measured using the Spinal Mouse device), balance (Single Leg Stance Test), trunk stability (Trunk Impairment Scale), and quality of life (Stroke-Specific Quality of Life Scale). Pre- and post-intervention assessments will be conducted to determine the effectiveness of the intervention. The study aims to establish evidence supporting the role of core stability exercises in improving posture, balance, and overall functional outcomes in stroke rehabilitation.

 
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