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CTRI Number  CTRI/2024/11/076846 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
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   A Combination Of Two Different Physiotherapy Techniques In University Students With Forward Head Posture 
Scientific Title of Study   A Combined Approach Of Deep Cervical Flexor Training And Post Isometric Relaxation Technique On Physiotherapeutic Outcomes In University Students With Forward Head Posture: A Randomised Controlled Trial 
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 Saurabh Sharma 
Designation  Associate Professor 
Affiliation  Jamia Millia Islamia 
Address  Room No- 104, 1st Floor, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, South Delhi-110025, India

South
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurabh Sharma 
Designation  Associate Professor 
Affiliation  Jamia Millia Islamia 
Address  Room No- 104, 1st floor, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, South Delhi-110025, India

South
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Ms Tasmia Siddiqui 
Designation  Post Graduate Student  
Affiliation  Jamia Millia Islamia 
Address  Room No- 207, 1st Floor, Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, South Delhi-110025, India

South
DELHI
110025
India 
Phone  9958324512  
Fax    
Email  tsiddiqui6217@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia, Jamia Nagar, Okhla, South Delhi-110025, India 
 
Primary Sponsor  
Name  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences,Jamia nagar, New Delhi-110025 
Type of Sponsor  Other [University funded by centeral goverment ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurabh Sharma  Room no. 201, Human performance lab, Centre for Physiotherapy and Rehabilitation Sciences  Room no-104 ,Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana md Ali Jauhar Marg, New Delhi-110025
South
DELHI 
9899214134

ssharma@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy  Static stretching exercises for upper trapezius and sternocleidomastoid muscle, 3 days per week for 4 weeks in addition to strengthening exercise of deep cervical flexors and scapular retractor muscles 3 sets of 12 repetitions with 6 seconds hold, total duration of each session will be 15 minutes. 
Intervention  Deep cervical flexor training  Deep cervical flexor training will be given using pressure biofeedback which will be placed over the suboccipital part and the patient is asked to do light nodding which will be started at 20 mmHg and 2mmHg pressure will be increased at every stage until 30mmHg pressure is reached. A total of 3 sets will be performed; one set will consist of repeating the motion 10 times for 10 seconds. The break time will be 5 seconds per movement for 4 weeks, 3 days a week, total duration of single session will be 15 minutes. In total 12 sessions will be given. Additionally 15 min hot pack will be given before the intervention. 
Intervention  Post isometric relaxation technique   post isometric relaxation technique for 4 weeks, 3days/week, total duration for a single session will be 15 minutes. In total 12 sessions will be given. The treatment will be directed towards relaxation for upper trapezius, Sternocleidomastoid muscle, and pectoralis minor muscle for 3 repetitions. Additionally a 15 min hot pack will be given before the intervention. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  subjects with CVA between 45-50 degrees
NDI value between 5- 24 (mild to moderate disability scores on NDI)
NPRS value between 3 -7
Both males and female between 19 to 28 years of age 
 
ExclusionCriteria 
Details  Patients with cervical spine and spinal deformities, congenital upper extremities
disorders.
No history of neck and shoulder surgery within the past three months
History of surgical or neurologic disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
craniovertebral angle
muscle activation
posture analysis 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Disability
Pain
Range of Motion 
4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   24/11/2024 
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="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   Introduction: 
Forward head posture (FHP) is characterized by excessive anterior positioning of the head about a vertical reference line, increased lower cervical spine lordosis (head forward, middle cervical spine extended, lower cervical spine flexed), rounded shoulders, and thoracic kyphosis. This can occur while sitting or standing. (Franke et al., 2015; Frey, G. 2011) .In a study conducted by Kim et al on the correlation between the degree of the FHP according to the craniovertebral angle (CVA) and the neck disability indices, it was found that the degree of the Forward Head Posture according to the CVA can be used as an important index in determining the resulting functional disability of the neck.(Nemmers et al., 2009).   Post-isometric relaxation is a muscle energy technique (MET) that involves moving the patient’s muscles in a certain direction against the therapist’s counterforce. This is accomplished by the Golgi tendon organ (GTO) when the muscle contracts isometrically. The Golgi Tendon Organ activates and responds by inhibiting reflexes and contracting antagonist muscles through submaximal contractions and stretching. It manages musculoskeletal disorders by restoring biomechanics, eliminating mobility restrictions, and relieving discomfort. (Scoppa, F. 2012)

Objective: To investigate the effect of deep cervical flexor training (DCFT) and post- isometric relaxation technique (PIR) on CVA in university students with forward head posture.
Significance of the study:
 The present study will elucidate the combined effect of post-isometric relaxation (PIR) technique and deep cervical flexor training on forward head posture. It will add information to the existing gap in knowledge by unraveling the combined effects of PIRT and DCFT on any alteration in the activation pattern of these muscles in university students with forward head posture and to incorporate in the rehabilitation of forward head posture patients.

Moreover, other studies have used photographic methods to analyze posture. Our study will use more reliable and valid software for posture analysis.

By comprehensively assessing multiple outcome measures, including Craniovertebral angle, posture, disability, pain intensity, Range of motion, and muscle activity, this study aims to provide a holistic understanding of the therapeutic potential of Deep Flexor Cervical Training and Post Isometric Relaxation Technique in managing Forward Head Posture. The result of the study can be directly used by clinicians to achieve improvements in patients with FHP.

NULL HYPOTHESIS:
• There will be no significant effect of deep cervical flexor training and post-isometric relaxation technique on a craniovertebral angle, EMG, posture, pain, disability, and ROM in university students with forward head posture
EXPERIMENTAL HYPOTHESIS: There will be a significant effect of deep cervical flexor training and post-isometric relaxation technique on a craniovertebral angle, EMG, posture, pain, disability, and ROM in university students with forward head posture.

Methods: Before initiating the study, subjects will be asked to fill NDI questionnaire as well as NPRS, following which their CVA, posture, range of motion, and muscle activation will be assessed. The pre-intervention evaluation will involve assessing the EMG % MVIC of specific muscles including the serratus anterior, sternocleidomastoid, and upper trapezius. After the initial assessment, the participating athletes will be randomly divided into Two groups. Group 1 will receive Post isometric relaxation technique along with DCFT, while Group 2 will receive a conventional physiotherapy treatment. Both groups will receive a hot pack for 15 min before exercise. Patients will be asked to perform the exercises 3 times a week for 4 weeks. Outcome measures will be assessed at baseline after 4 weeks of training and after 6 weeks of follow-up. DCFT will be done using pressure biofeedback which will be placed over the suboccipital part and the patient is asked to do light nodding which will be started at 20 mmHg and 2mmHg pressure will be increased at every stage until 30mmHg pressure is reached A total= of 3 sets will be performed; one set will consist of repeating the motion 10 times for 10 seconds. The break time will be 5 seconds per movement for 4 weeks. (Juchul et al., 2018). When the performance was correctly conducted in each stage without reward mobility, the pressure was increased in the next stage. (Fernandez et al., 2007) PIRT for Upper trapezius, Sternocleidomastoid muscle, and pectoralis minor muscle, each muscle received 3 repetitions, 3 sessions per week over 4 weeks. (Haytham et al., 2023). For pectoralis minor: the patient is asked to apply approximately 20% of his strength to protract the shoulder girdle in the supine position or asked to match the therapist’s strength. The isometric contraction will be maintained for 7 seconds while holding the breath and then the patient was asked to relax and exhale. During the period of relaxation, the therapist will stretch the pectoralis minor muscle to its new length and the stretch force will be maintained for 10 seconds (Prerana & Amarnatha, 2019). For upper trapezius and sternocleidomastoid muscles are stretched by the therapist moving the subject’s head into the appropriate position. Once resistance or a barrier is felt, the position is maintained, and the subjects will be instructed to isometrically contract the target muscle for 5 seconds at 20% of their maximum contraction against light resistance from the therapist. Then, the subjects are instructed to relax for 5 seconds before passively stretching for 30 seconds until reaching a new barrier. (Haytham et al., 2023) After every 10 sessions, examine the CVA, if there is an increase of 1 degree then progress to the next stage otherwise the patient will remain in the same stage. Control group: will receive conventional treatment as, static stretching exercise for upper trapezius and sternocleidomastoid. 3 days/week throughout 4 weeks, in addition to strengthening exercises of deep cervical flexors and scapular retractor muscles, 3 sets of 12 repetitions with 6-sec hold in addition to postural advice. ( Haytham et al., 2023)

 
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