| CTRI Number |
CTRI/2022/10/046819 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship of Hand strength among Smartphone Users |
|
Scientific Title of Study
|
Association of Hand and Pinch Grip Strength among High and Low Risk Adolescent Smartphone Users: A Cross- Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puspangi Agarwal |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute if Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed to be University), Mullana
Ambala
HARYANA
133207
India |
| Phone |
7865841874 |
| Fax |
|
| Email |
puspangiag2330@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aksh Chahal |
| Designation |
Associate Professsor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed to be University), Mullana
Ambala
HARYANA
133207
India |
| Phone |
|
| Fax |
|
| Email |
prof.aksh_chahal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aksh Chahal |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed to be University), Mullana
Ambala
HARYANA
133207
India |
| Phone |
|
| Fax |
|
| Email |
prof.aksh_chahal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Physiotherapy Research Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to eb University), Mullana, Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Puspangi Agarwal |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to eb University), Mullana, Ambala, Haryana, 133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aksh Chahal |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to eb University), Mullana, Ambala, Haryana, 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Puspangi Agarwal |
MM International School |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to eb University)
Ambala
HARYANA |
7865841874
puspangiag2330@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adolescent participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand Grip and Pinch Grip Strength measurement |
Hand and pinch grip strength measurements will be assessed using Baseline Hydraulic Handheld Dynamometer and Hydraulic Pinch Gauge for high risk and low risk adolescent smartphone users on an average of 3 trials in a single session |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1. Sedentary lifestyle
2. Age 10 to18 years
3. Male and female
4. Able to follow verbal commands
5. Regularly using an Android/IOS mobile phone
|
|
| ExclusionCriteria |
| Details |
1. History of hand and wrist fracture/ injury
2. History of nerve injuries related to upper limb
3. Neuromuscular disorders of upper limb
4. Professional sportsmen and/or recreational players
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Baseline Hydraulic Handheld Dynamometer
Hydraulic Pinch Gauge |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale |
Once after trial |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/10/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ethical approval of this study will be taken from the student project committee and ethical committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. Study will be done in accordance with Helsinki declaration revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participants, 2017. the objective of the planned study is to compare
hand and pinch grip strength among high and low adolescent smartphone users
along with exploring anthropometric factors associated with variations in hand
and pinch grip strength. Participants between 10 and 18 years will be
recruited after fulfilling the selection criteria. Hand measurements (hand
length, hand width, palm length and maximum spread of hand) will be taken using
a measuring tape. Hand and pinch grip strength measurements will be assessed
using Baseline Hydraulic Handheld Dynamometer and Hydraulic Pinch Gauge. The
comparison will be done by grouping the participants under two categories: high
and low users using the Smartphone Addiction Scale (SAS)-Short version. Further
thumb pain due to smartphone usage will be assessed using Visual Analog Scale (VAS).
Outcome measures shall be Baseline Hydraulic Handheld Dynamometer,
Hydraulic Pinch Gauge and Visual Analog Scale (VAS).
|