| CTRI Number |
CTRI/2024/07/069999 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
immediate effects of neural mobilization techniques on hand functions in healthy smartphone overuse users |
|
Scientific Title of Study
|
Immediate effects of neural mobilization techniques on grip strength and pinch strength in asymptomatic smartphone addicted users |
| 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 Kavita Sudhakar |
| Designation |
Assistant Professor |
| Affiliation |
Saket college of physiotherapy,chandimandir,panchkula |
| Address |
Room No. 64 1st floor, Saket College of Physiotherapy, Chandimandir, Panchkula.
Panchkula
HARYANA
134109
India |
| Phone |
9501586080 |
| Fax |
|
| Email |
physiokavitasudhakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Sudhakar |
| Designation |
Assistant Professor |
| Affiliation |
Saket college of physiotherapy,chandimandir,panchkula |
| Address |
Room No. 64 1st floor Saket College of Physiotherapy, Chandimandir, Panchkula.
Panchkula
HARYANA
134109
India |
| Phone |
9501586080 |
| Fax |
|
| Email |
physiokavitasudhakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirti |
| Designation |
MPT student |
| Affiliation |
Saket college of physiotherapy,chandimandir,panchkula |
| Address |
room No. 55, ground floor Saket college of Physiotherapy, Chandimandir, Panchkula
Panchkula
HARYANA
134109
India |
| Phone |
7988328051 |
| Fax |
|
| Email |
kirtibhardwaj1309@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kirti. Address: MPT student Room no. 55 college of rehabilitation centre, Saket College of Physiotherapy, Chandimandir, Panchkula Haryana 134107 |
|
|
Primary Sponsor
|
| Name |
Dr Kirti |
| Address |
Saket College of Physiotherapy, Chandimandir, Panchkula. 134109 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| kirti |
Saket College of Physiotherapy, Chandimandir, Panchkula. |
Room No. 55, college rehabilitation center Saket College of Physiotherapy, Chandimandir, Panchkula.
Government postgraduate college sector 1 Panchkula.
E-Block college of Physiotherapy, PGIMS, Rohtak.
Panjab University, Sector 15, Chandigarh.
Panchkula
HARYANA |
7988328051
kirtibhardwaj1309@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 |
| Healthy Human Volunteers |
neural mobilization |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neural mobilization of median nerve by sliders technique
|
Neural mobilization of sliders technique will be given 6seconds per cycle. 3 sets of 10 repetition will be performed.
|
| Comparator Agent |
Neural mobilization of median nerve by tensioners technique
|
Neural mobilization of tensioners technique will be given 6seconds per cycle. 3 sets of 10 repetition will be performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female smartphone users.
2. Smartphone addicted users who have been using smartphone for more than 6 hours from 2 years or more.
3. Subjects who be willing to participate. |
|
| ExclusionCriteria |
| Details |
1. Subject experiencing any neck or dominant upper extremity pain or other symptoms.
2. Previous history of any injury or congenital or diagnosed disease or surgery which can affect study variables.
3. Any diagnosed case of malignancy.
4. Subject using vibratory mechanical devices in daily use.
5. Participants complaining of pain or symptoms related to any neurological conditions in upper extremity. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Grip strength
Pinch strength |
Baseline (pre-intervention)
Immediately post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this study We will find out the immediate effects of neural mobilization techniques on grip and pinch strength. Pre and post measurements of grip strength and pinch strength( lateral pinch, two point pinch, and three point pinch) of smartphone addicted users who have using smartphone for more than 6 hours from 2 years will be measured. The participants will be divided into 3 groups and will get either median nerve mobilization by sliders technique or median nerve mobilization by tensioners techniques or sham group(no treatment). Post intervention measurements of grip strength and pinch strength( lateral pinch, two point pinch, and three point pinch will be taken immediately. The data will be analyzed using appropriate statistical tests. |