| CTRI Number |
CTRI/2024/05/067916 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| 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
|
Enhancing hand grip strength: The impact of strengthening exercises for smart phone users |
|
Scientific Title of Study
|
Effectiveness of strengthening exercise on reduced hand grip strength among smartphone 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 |
U Pooja |
| Designation |
Post graduate student |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
The Department of Musculoskeletal
sciences-Physiotherapy,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068
Bangalore
KARNATAKA
560068
India
Bangalore
KARNATAKA
560068
India |
| Phone |
8317421002 |
| Fax |
|
| Email |
poojaryan2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rucha Bhaskarwar |
| Designation |
Associate professor |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
The Department of Musculoskeletal
sciences-Physiotherapy,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068
Bangalore
KARNATAKA
560068
India
Bangalore
KARNATAKA
560068
India |
| Phone |
9960809575 |
| Fax |
|
| Email |
dr.richa29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Vasanthan |
| Designation |
Principal |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Department of Musculoskeletal
sciences-Physiotherapy,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068
Bangalore
KARNATAKA
560068
India
Bangalore
KARNATAKA
560068
India |
| Phone |
09916919685 |
| Fax |
|
| Email |
physiotherapyprincipal@theoxford.edu |
|
|
Source of Monetary or Material Support
|
| Oxford College of Nursing,,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068
Bangalore
KARNATAKA
560068
India |
| Oxford College Of Pharmacy ,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068
Bangalore
KARNATAKA
560068
India |
| Oxford College of Physiotherapy,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068
Bangalore
KARNATAKA
560068
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| U Pooja |
Oxford College Of Nursing Sciences |
No.6/9 , 1st Cross , Begur Road, Hongasandra, Bengaluru - 560068, Department of nursing room number 8, fifth floor
Bangalore
KARNATAKA |
08317421002
poojaryan2@gmail.com |
| U Pooja |
The Oxford College Of Pharmacy |
No. 6/9, 1st Cross, Begur Road, Hongasandra, Bengaluru - 560068,Department of Pharmacy, room number 202, first floor
Bangalore
KARNATAKA |
08317421002
poojaryan2@gmail.com |
| U pooja |
The Oxford College Of Physiotherapy |
No. 6/9, 1st Cross, Begur Road,
Hongasandra, Bengaluru, Department of Physiotherapy OPD, room number 1, ground floor 560068,
Bangalore
KARNATAKA |
08317421002
poojaryan2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford College of Physiotherapy Review Board for Ethics and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Reduced handgrip strength |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative Management |
Basic Strengthening exercise
1. squeeze ball
2. activities using clay
3. Thumb extension using rubber band and (Ultrasound exclusively when pain is present ) 3 days a week (3 weeks) |
| Intervention |
Strengthening exercise
|
1. hand gripper exercise
2. Resistance band exercise
3. Dumbbell hold
4. wrist curls with dumbbell
5. pinch strengthener
intervention will be given for 3 days a week (3 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age (18-25)
2. Smartphone usage duration more than 4 hours
3. With or without active thumb pain
4. Both male and female
5. Smartphone usage of minimum 6 months |
|
| ExclusionCriteria |
| Details |
1. Cardiac Problems
2. Recent Injury
3. Students indulged in gym training
4. Vascular disorders
5. Nerve Injury |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength using Dynamometer |
0 week and 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Upper extremity functional index-scale (20) |
0 week and third week |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 4 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| 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="5"
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
|
Background : The widespread use of smartphones, particularly among youth, has raised concerns about excessive dependency and its impact on behavior and physical health. Prolonged smartphone use has been linked to musculoskeletal issues such as tendinosis and carpal tunnel syndrome, affecting hand strength and daily activities. Understanding these effects is crucial for promoting hand health and preventing problems associated with smartphone addiction. Methods : RCT recruiting 82 subjects with reduced handgrip strength among smartphone users. Participants will be divided into two groups. Pre-intervention measurements, including hand-held dynamometry and Upper Extremity Functional Index Scale, will be conducted. Experimental group comprising 41 subjects will undergo a 3-week strengthening exercise regimen, including hand gripper exercises, resistance band exercises. Control group with 41 subjects will receive conservative management, involving basic exercises and ultrasound treatment only when pain is present. |