| CTRI Number |
CTRI/2025/02/080373 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| 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
|
EFFECTIVENESS OF THORACIC MOBILITY EXERCISES VERSUS FOAM ROLLER TRAINING ON INDEX OF KYPHOSIS AND THORACIC EXPANSION AMONG YOUNG ADULTS WITH POSTURAL KYPHOSIS |
|
Scientific Title of Study
|
EFFECTIVENESS OF THORACIC MOBILITY EXERCISES VERSUS FOAM ROLLER TRAINING ON INDEX OF KYPHOSIS AND THORACIC EXPANSION AMONG YOUNG ADULTS WITH POSTURAL KYPHOSIS – 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 Sunidhi Shinde |
| Designation |
Masters Of Musculoskeletal Physiotheraphy |
| Affiliation |
Maharashtra Institute Of Physiotherapy Latur |
| Address |
Musculoskeletal Department OPD Number 15 Maharashtra Institute Of Physiotherapy Vishwanathpuram Ambajogai road latur 413 531 Maharashtra India
Latur
MAHARASHTRA
413531
India |
| Phone |
8888547849 |
| Fax |
|
| Email |
sunidhi10010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
HOD and Professor of Musculoskeletal Department |
| Affiliation |
Maharashtra Institute Of Physiotherapy Latur |
| Address |
Musculoskeletal Department OPD Number 15 Maharashtra Istitute Of Physiotherapy Vishwanathpuram Ambajogai road latur 413 531 Maharashtra India
Latur
MAHARASHTRA
413 531
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
HOD and Professor of Musculoskeletal Department |
| Affiliation |
Maharashtra Institute Of Physiotherapy Latur |
| Address |
Musculoskeletal department OPD Number 15 MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY Vishwanathpuram Ambajogai road latur 413 531 Maharashtra India
Latur
MAHARASHTRA
413 531
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Department OPD Number 15 Maharashtra Istitute Of Physiotherapy Vishwanathpuram Ambajogai road latur 413 531 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute Of Physiotheraphy Latur |
| Address |
Musculoskeletal Department OPD Number 15 Maharashtra Istitute Of Physiotherapy Vishwanathpuram Ambajogai road latur 413 531 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sunidhi Shinde |
Maharashtra Institute Of Physiotherapy Latur |
Department Of Musculoskeletal Physiotherapy, OPD-15, Maharashtra Institute Of Physiotheraphy MIMSR medical campus Ambajogai Latur
Latur
MAHARASHTRA |
8888547849
sunidhi10010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FOAM ROLLER TRAINING |
1.Sustained extension in supine
2.Sustained extension to flexion in spine
3.The FRSM full form in supine
4.The FRSM in standing
All the above mention exercise will be given for the 3 weeks
|
| Intervention |
THORACIC MOBILITY EXERCISES |
1.Extension in sitting
2.Extension in sitting with over pressure
3.Mid and lower thoracic sustained prone lying in extension
4.Cat and camel pose
All the exercise will be given for the 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Both |
| Details |
•Thoracic hyperkyphosis angle more than 40 degree
|
|
| ExclusionCriteria |
| Details |
• Any traumatic injury to spine
• Fracture to thoracic spine
• Recent surgery of spine
• Vertebral artery insufficiency
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Index Of Kyphosis
2. Thoracic Expansion Test |
1. Index Of Kyphosis
2. Thoracic Expansion Test
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/02/2025 |
| 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="0"
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 procedure will start after approval from the Institutional Ethical Committee. The purpose of the study will be explained to each
participant and a written informed consent will be taken in a language
they understand. Participants will be screened and recruited for the
study on the basis of inclusion and exclusion criteria. Participants will
be indexed as per their visit in OPD. Odd number participants will be added in group A and even number
participants will be added in group B. Participants in group A will receive thoracic mobility exercises. Participants in group B will receive foam roller training. The intervention will include for 3 weeks. After the 3 weeks of intervention post data will be obtained at the end of 3rd week by using Index of Kyphosis and Thoracic Expansion Test.
|