| CTRI Number |
CTRI/2021/09/036736 [Registered on: 22/09/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2022 |
| 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
|
Effects of Callisthenic and Motor control exercises in individuals with forward head posture |
|
Scientific Title of Study
|
Comparative effects of callisthenic exercises and motor control exercises in individuals with asymptomatic forward head posture on craniovertebral angle and postural stability - A Randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutuja Phadke |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
Department of orthopedic physiotherapy, KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar Belagavi
Department of orthopedic physiotherapy,KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845205171 |
| Fax |
|
| Email |
rutuja.phadke9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peeyoosha gurudut |
| Designation |
Associate Professor |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
Department of orthopedic physiotherapy, KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar Belagavi
Department of orthopedic physiotherapy,KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845205171 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutuja Phadke |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
Department of orthopedic physiotherapy, KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar Belagavi
Department of orthopedic physiotherapy,KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845205171 |
| Fax |
|
| Email |
rutuja.phadke9@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER institute of physiotherapy |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy, JNMC Campus, Nehru Nagar Belagavi |
| 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 |
| rutuja phadke |
KAHER Institute of physiotherapy |
Department of orthopedic physiotherapy,KAHER Institute of physiotherapy, Nehru nagar, Belagavi
Belgaum
KARNATAKA |
9845205171
rutuja.phadke9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Institute of physiotherapy research and ethics committe |
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 |
Callisthenic exercises |
3 times a week for 4 weeks
10 minutes warm up
40 mins 3 times a week for 4 weeks
10 minutes warm up
Callisthenics- 40 minutes
10 minutes cool down
10 minutes cool down |
| Comparator Agent |
motor control exercise |
3 times a week for 4 weeks
10 minutes warm up
40 mins 3 times a week for 4 weeks
10 minutes warm up
Motor control exercises- 40 minutes
10 minutes cool down
10 minutes cool down |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with forward head posture with CVA< 53° degree
All genders with age group 18 to 40 years, who are asymptomatic (without neck pain) for at least 3 weeks
Participants willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Postural deviation other than forward head, assessed by observation method that could affect postural stability
Fracture, trauma, injury or recent surgeries that would prevent the participants to perform the exercises
History of tumors and infection of the vertebrae
Diagnosed cases of vestibular disorders and peripheral neuropathy
Participants who are unable to comprehend the exercise commands
Pregnant women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Craniovertebral angle
Postural stability
Craniocervical flexion endurance |
At baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participant selection will be done as per the Inclusion and exclusion criteria.The purpose and procedure of the study will be explained to the participants. All the covid-19 precautionary measures according to ICMR will be taken. A brief demographic data and baseline outcome measures (Craniovertebral angle, pressure biofeedback, postural stability) will be obtained from the participants. Participants will be equally divided into two groups using chit method Group therapy sessions will be carried out in the respective colleges of KAHER institute. Group A will be given Callisthenics and Group B will be given Motor Control exercises |