| CTRI Number |
CTRI/2024/05/066698 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Effect of Brugger’s Exercise Program and Comprehensive Corrective Exercise Program on pain, posture, length of muscle in postural dysfunction |
|
Scientific Title of Study
|
A Comparative Study on Brugger’s Exercise Program and Comprehensive Corrective Exercise Program in Treatment of Upper Crossed Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragnya jyoti dash |
| Designation |
PHD SCHOLAR |
| Affiliation |
SHARDA UNIVERSITY |
| Address |
Department of Physiotherapy, Room number B319 Galgotias University, Greater Noida, Uttar Pradesh
Department of Physiotherapy, Room number B319 Galgotias University, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9475427313 |
| Fax |
|
| Email |
pragnyajyotidash111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pragnya jyoti dash |
| Designation |
PHD SCHOLAR |
| Affiliation |
SHARDA UNIVERSITY |
| Address |
Department of Physiotherapy, Room number B319 Galgotias University, Greater Noida, Uttar Pradesh
Department of Physiotherapy, Room number B319 Galgotias University, Greater Noida, Uttar Pradesh
UTTAR PRADESH
201310
India |
| Phone |
9475427313 |
| Fax |
|
| Email |
pragnyajyotidash111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Suyash Saxena |
| Designation |
Assistant Professor |
| Affiliation |
SHARDA UNIVERSITY |
| Address |
Department of Biochemistry, Room number 610, block 4, Sharda University, Greater Noida, Uttar Pradesh
Department of Biochemistry, Room number 610, block 4, Sharda University, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9718620345 |
| Fax |
|
| Email |
suyesh.saxena@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| E003
Department of Physiotherapy
School of allied and health science
Galgotias university
UP |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Pragnya Jyoti Dash |
GALGOTIAS UNIVERSITY |
E 003, GALGOTIAS UNIVERSITY, GREATER NOIDA, UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9475427313
pragnyajyotidash111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brugger’s exercise Program
|
Brugger’s exercise Program
5 day/ week for 12 week |
| Comparator Agent |
comprehensive corrective exercise program |
comprehensive corrective exercise program
5 days/ week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients with Upper Cross Syndrome between the Age of between 15 to 30 years, both male and female
Participants with constantly or frequently occurring neck–shoulder pain
With or without radiating pain in upper extremities |
|
| ExclusionCriteria |
| Details |
Cord compression
Spinal tumours
Congenital shoulder deformities
Recent fractures to related joints
Recent surgery.
Severe osteoporosis
Cervical myelopathy
Ligamentous instability
Vertebral artery insufficiency
Patients on Analgesics and Anti-inflammatory drugs
Ankylosing Spondylitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pectoralis Minor Length Test
Craniovertebral Angle Test
Craniocervical Flexion Test |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Scapular Dyskinesis Test
Scapular Index
Oswestry neck disability index questioner |
6 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/05/2024 |
| 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
|
Dr. Alois Brugger (MD), a Swiss neurologist and neurophysiologist,
invented "Brugger’s Therapy" to treat functional problems of the
locomotor system and diagnose these illnesses. The Complete
Corrective Workout Program has three phases: the initial, improvement, and
maintenance phases. The exercise’s initial design put a lot of emphasis on the
scapular muscles, which involve isometric muscle contraction in the scapular
position. The addition of upper extremity motions in different training
situations can be done when the patient has restored the muscular balance.
|