| CTRI Number |
CTRI/2024/03/064834 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study will be doing on effect of release in individual with forward head and respiratory function chnages
|
|
Scientific Title of Study
|
Evaluating the effect of combination release technique on craniovertebral angle and respiratory functions using spirometry in asymptomatic individuals with forward head posture: A randomized placebo clinical 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 |
Aarti Welling |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of Orthopedic Physiotherapy, KAHER Institute of Physiotherapy, Belagavi, Karnataka, India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti Welling |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of Orthopedic Physiotherapy, KAHER Institute of Physiotherapy, Belagavi, Karnataka, India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranjal Patil |
| Designation |
Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Department of Orthopedic Physiotherapy, KAHER Institute of Physiotherapy, Belagavi, Karnataka, India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
pranjal2251@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy Nehru Nagar belgaum , Karnataka 590001 |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Nehru nagar belgaum Karnataka |
| 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 Aarti Welling |
KLEs Dr Prabhakar Kore hospital and research centre |
Department of orthopaedic physiotherapy OPD no 39 room no 18 Nehru Nagar belgaum
Belgaum
KARNATAKA |
9448814569
aartiwell88@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
Forward Head Posture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined Release technique |
Positional release technique and stretching this will be done 5 times a week for 2 weeks |
| Comparator Agent |
Placebo |
PRT and Stretching - placebo
This will be done 5 times a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with Forward Head Posture
CVA less than 48-50 degree |
|
| ExclusionCriteria |
| Details |
Pregnancy
Individuals undergone spinal surgeries
Vertebral deformity
Joint diseases like arthritis and spondylolisthesis
Radiculopathy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kinovea app for FHP assessment
PFT for respiratory function |
Pre- baseline
Post- after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PFT for respiratory function |
Pre- baseline
Post- after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
08/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 intended work focuses on the impact of Forward Head Posture (FHP) on the cervical spine and respiratory function, exploring the potential effects of myofascial release techniques on correcting this posture and improving respiratory capabilities. FHP can cause various musculoskeletal issues, affect respiratory function, and alter body balance. The study aims to assess how myofascial release techniques influence the Craniovertebral Angle (CVA) and respiratory function in asymptomatic individuals with FHP. The research design involves an experimental trial using Kinovea software for CVA measurements and Spirometry for pulmonary function testing. The intervention includes myofascial release therapy in one group and a placebo in another. Statistical analysis will determine the therapy’s effects. Numerous studies support the correlation between FHP, posture, respiratory function, and musculoskeletal issues, providing a comprehensive background for this research. |