| CTRI Number |
CTRI/2024/08/072676 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the relation between the stamina of deep muscles of neck and hand grip strength in healthy people |
|
Scientific Title of Study
|
Relationship between deep neck flexor endurance and hand grip strength in asymptomatic individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maitreyee Mandar Garud |
| Designation |
Post graduate student |
| Affiliation |
PG student |
| Address |
Dr D Y Patil College of Physiotherapy, 3rd floor, Department of Musculoskeletal Physiotherapy, Sant Tukaram Nagar,Pimpri-Chinchwad, Maharashtra
Dr D Y Patil College of Physiotherapy, Dr D Y Patil Vidyapeeth, Sant Tukaram Nagar, Maharashtra, Pimpri, Pune-411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9823090491 |
| Fax |
|
| Email |
maitreyee.garud@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Palekar |
| Designation |
Principal |
| Affiliation |
Dr D Y Patil College of Physiotherapy |
| Address |
Dr D Y Patil College of Physiotherapy, 3rd floor, Department of Musculoskeletal Physiotherapy, Sant Tukaram Nagar,Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9822606869 |
| Fax |
|
| Email |
principal.physio@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Maitreyee Mandar Garud |
| Designation |
Post graduate student |
| Affiliation |
Dr D Y Patil College of Physiotherapy |
| Address |
Dr D Y Patil College of Physiotherapy, 3rd floor, Department of Musculoskeletal Physiotherapy, Sant Tukaram Nagar,Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9823090491 |
| Fax |
|
| Email |
maitreyee.garud@gmail.com |
|
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Source of Monetary or Material Support
|
| 3rd floor, Musculoskeletal Department of Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018, Maharashtra |
|
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Primary Sponsor
|
| Name |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune-411018 |
| Type of Sponsor |
Other [(Deemed University)] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Maitreyee Garud |
Aditya Shagun Society, Bavdhan, Pune |
Aditya Shagun Society, NDA Pashan Road, Bavdhan, Pune-411021
Pune
MAHARASHTRA |
9823090491
maitreyee.garud@gmail.com |
| Maitreyee Garud |
Dr. D.Y. Patil Physiotherapy College, Pimpri, Pune |
Dr. D.Y. Patil Physiotherapy College, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
9823090491
maitreyee.garud@gmail.com |
| Maitreyee Garud |
Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune |
Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
9823090491
maitreyee.garud@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Aditya Shagun society, bavdhan, pune |
Approved |
| Institutional Ethics Committee of Dr. D.Y. Patil College Of Physiotherapy, Pune |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of 20-40 years of both genders will be included in the study. |
|
| ExclusionCriteria |
| Details |
Individuals having any musculoskeletal or neurological disorders will be excluded from the study. |
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Method of Generating Random Sequence
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Deep Neck Flexor Endurance Test |
It will be assessed only once. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength |
Hand Grip strength will be assessed of both dominant and non dominant hand. Three measurements will be done on each side and the mean of the data will be used for further analysis. |
|
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Target Sample Size
|
Total Sample Size="309"
Sample Size from India="309"
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)
|
29/09/2024 |
| 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
|
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Brief Summary
|
TITLE: Relationship between deep neck flexor endurance and hand grip strength in asymptomatic individuals.
AIM: To study the relationship between deep neck flexor endurance and hand grip strength in asymptomatic individuals.
OBJECTIVES: 1.To assess deep neck flexor endurance using the deep neck flexor endurance test. 2.To assess hand grip strength using the hand-held dynamometer.
NEED OF STUDY: •The deep neck flexors are mainly identified as the longus colli and longus capitis. These muscles play an important role in maintaining posture and stability of neck. Weakness of these muscles have a significant impact on cervical spine function. •Hand grip strength is necessary for various activities of daily living including heavy work and fine motor skills. It provides an objective index of the functional integrity of the upper extremity. [4] •Previous studies suggest that weakness of deep cervical flexors causes neck pain and patients having non specific neck pain have reported a reduced hand grip strength. •Thus, neck pain is a factor that leads to a reduced hand grip strength in individuals with neck pain. However, whether there are any relationship exists between deep neck flexor endurance and hand grip strength in asymptomatic individuals needs to be investigated. •In essence, this study can contribute to the existing literature by filling gaps in understanding the significance between deep cervical flexor endurance and hand grip strength. Examining these two components could contribute to a more comprehensive understanding of the musculoskeletal system.
HYPOTHESIS NULL HYPOTHESIS: There will be no relationship between deep neck flexor endurance and hand grip strength in asymptomatic individuals. ALTERNATIVE HYPOTHESIS: There will be a relationship between deep neck flexor endurance and hand grip strength in asymptomatic individuals.
OUTCOME MEASURES 1.Deep Neck Flexor (DNF) Endurance Test 2.Hand Grip Strength
PROCEDURE-
1.Deep Neck Flexor (DNF) Endurance Test: Inter rater reliability (ICC) of DNF Endurance Test is 0.82-.91 For this test to be performed, the patient lies in hook lying position. The patient is then instructed to maximally retract the chin and lift the head and neck until the head is round about 2.5cm or 1 inch above the couch. The patient is asked to hold this position as long as he can and the length of time will be measured using a stopwatch. The test will end either when the line along patient neck starts to isolate or the patient head touches the examiner hand for more than one second.[6] 2.Hand Grip Strength: Hand grip strength will be assessed using the hand held dynamometer. The subjects will be seated with their shoulder adducted and neutrally rotated, elbow flexed at 90°, forearm and wrist in neutral position. Subjects will be asked to hold dynamometer in their dominant hand, at their side without touching rest of the body, and squeeze it forcefully. Three trials will be given, and the mean of the three trial will be calculated and taken as mean grip strength. [4] ETHICAL CONSIDERATIONS- •Voluntary participation will be ensured. •Informed consent will be obtained from all participants prior to enrolment. •Participants will be explained about the purpose of the study. •Research participants wont be harmed in any way. •Patient/ Participant’s privacy and confidentiality will be ensured.
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