| CTRI Number |
CTRI/2024/10/075114 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving quality of life of and spinal curvatures in individuals with rounded shoulders and hyperkyphosis combining effect of pillates and sahrmann s exercise by face to face approach and supervised trial |
|
Scientific Title of Study
|
Optimising Quality of Life and Spinal Curvatures in Individuals with Rounded Shoulders and Hyperkyphosis Combining Effect of Supervised and Tele-rehabilitation Trial Comparing Sahrmann s and Pilates Exercise Protocol |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Chabada |
| Designation |
PG student |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy Opd no 39 room no 18 Nehru Nagar Belagavi Karnataka
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy Opd no 39 room no 18 Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
nishachabada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy Opd no 39 room no 18 Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy Opd no 39 room no 18 Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research Nehru Nagar Belgaum 590001 |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy Opd no 39 room no 18 Nehru Nagar Belagavi Karnataka 590010 |
| 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 |
| Dr Vijay Kage |
KLE DR.Prabhakar Kore hospital and medical research centre |
KAHER Institute of Physiotherapy Department of Orthopedic Physiotherapy Opd no 39 room no 18 Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA |
9845271899
vijaykage@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sahrmann s Exercise Protocol
|
Sahrmann s Exercise Protocol will be Given thrice a week for 6 weeks |
| Intervention |
Pilates Protocol |
Pilates Protocol will be given thrice a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All gender individuals ranging from 18-45 years
Asymptomatic individuals with Kyphosis Index (KI) greater than 13 and pectoralis minor tightness.
Willing to Participate, comprehend and co-operative
Individuals who have access to Smartphones devices or tablets with internet connectivity.
|
|
| ExclusionCriteria |
| Details |
Individuals with Congenital Spinal Anomalies, Structural kyphosis (post TB gibbus)
History of spinal column fracture, Spinal tumours, History of trauma, fractures and Rheumatoid arthritis
Neurological, and cardiological abnormalities.
History of orthopaedic surgery (total hip, knee replacements, neck shoulder
surgeries or hand injuries)
Serious medical conditions and surgical conditions that do not allow the participate in the program.
Pregnancy
Psychological disorders affecting the subject’s ability to follow the instructions
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Kyphosis Index using Flexicurve, Assessment of Pectoralis Minor Tightness By Tabletop Test, Craniovertebral Angle By Photographic Method, Quality of life using RAND SF-36 Questionnaire |
At baseline and after 2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2031 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
OPTIMIZING QUALITY OF LIFE AND SPINAL CURVATURES
IN INDIVIDUALS WITH ROUNDED SHOULDERS AND HYPERKYPHOSIS: COMBINING EFFECT OF
SUPERVISED AND TELE-REHABILITATION TRIAL COMPARING SAHRMANN’S AND PILATES
EXERCISE PROTOCOL.
AIM OF THE STUDY - To study
and compare
the combined effect of supervised and telerehabilitation trial for sahrmann’s and
pilates exercise protocol on quality of life and spinal curvatures in
individuals with rounded shoulders and •
Null
hypothesis H0: There
will be no difference in the effect of supervised and
telerehabilitation trial comparing sahrmann’s and pilates exercise protocol on quality of life and
spinal curvature angles in individuals with rounded shoulders and hyperkyphosis
INCLUSION CRITERIA: All gender individuals ranging from 18-45 years , Asymptomatic individuals with Kyphosis Index (KI)
greater than 13 and pectoralis minor tightness , Willing to Participate, comprehend and co-operative , Individuals who have access to Smartphones devices
or tablets with internet connectivity.EXCLUSION CRITERIA: with Congenital
Spinal Anomalies, Structural kyphosis (post TB gibbus), History of spinal column
fracture, Spinal tumours, History of trauma, fractures and Rheumatoid arthritis , Neurological, and
cardiological abnormalities. History of orthopaedic
surgery (total hip, knee replacements, neck shoulder surgeries or hand
injuries) Serious medical conditions and surgical conditions
that do not allow the participate in the program , Pregnancy Psychological disorders affecting
the subject’s ability
to follow the instructions |