| CTRI Number |
CTRI/2025/06/088851 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| 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 study to evaluate the effect of shoulder exercises on head posture and hand functions in heavy smartphone users. |
|
Scientific Title of Study
|
Effect of scapular stabilizing exercises on craniovertebral angle, 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 SudhakarPT |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy, Panchkula |
| Address |
Saket College of Physiotherapy, Chandimandir, Department of Physiotherapy, room no. 64
Panchkula
HARYANA
134107
India |
| Phone |
9501586080 |
| Fax |
|
| Email |
physiokavitasudhakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita SudhakarPT |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy, Panchkula |
| Address |
Saket College of Physiotherapy, Chandimandir, Department of physiotherapy, room no. 64
Panchkula
HARYANA
134107
India |
| Phone |
9501586080 |
| Fax |
|
| Email |
physiokavitasudhakar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanshika Khurana PT |
| Designation |
MPT student |
| Affiliation |
Saket college of Physiotherapy, Panchkula |
| Address |
Saket college of Physiotherapy, Chandimandir, Department of Physiotherapy, room no. 55
Panchkula
HARYANA
134107
India |
| Phone |
8816070867 |
| Fax |
|
| Email |
vanshikakhurana0@gmail.com |
|
|
Source of Monetary or Material Support
|
| I will myself bear the other costs required. Address: Vanshika Khurana, MPT student, Saket College of Physiotherapy, Chandimandir, Panchkula, India, 134107 |
|
|
Primary Sponsor
|
| Name |
Dr Vanshika Khurana PT |
| Address |
Saket College Of Physiotherapy, Chandimandir, Panchkula, India, 134107 |
| 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 |
| Vanshika Khurana |
Saket College of Physiotherapy |
Department of Physiotherapy, room no. 55
Panchkula
HARYANA |
8816070867
vanshikakhurana0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Scapular Stabilizing exercises |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ergonomic education |
An ergonomic educational leaflet will be provided and the participants will be apprised about maintaining correct posture while using smartphone for a period of 4 weeks. The usage of the ergonomic educational leaflet will be monitored every week via phone calls and short messaging services. |
| Intervention |
Scapular Stabilizing exercises plus ergonomic education |
A total of 3 exercises will be performed for 10 repetitions with 10 seconds hold , 3 sets per day with a frequency of 3 days per week for a duration of 4 weeks. In addition to the exercises ergonomic education leaflet will be provided which will be reviewed weekly for a total duration of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female in the age group 18-40 years.
2. Smartphone users who have been using smartphone for more than 4 hours for more than 1 year.
3. Subjects who will be willing to participate. |
|
| ExclusionCriteria |
| Details |
1. Participants complaining of pain or symptoms related to any cardiovascular, musculoskeletal or neurological dysfunction in neck or dominant upper extremity that may affect study variables.
2. Previous history of any injury or congenital or diagnosed disease or surgery which may affect study variables.
3. Any diagnosed case of malignancy |
|
|
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
Grip strength
Pinch strength |
At baseline (pre-intervention) and
At 4 weeks (post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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 3 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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 evaluate the effect of scapular stabilizing exercises on craniovertebral angle, grip strength and pinch strength in asymptomatic smartphone addicted users. Pre and post measurements of craniovertebral angle, grip and key pinch strength of smartphone addicted users who are using smartphone for more than 4 hours per day for more than 1 year will be documented. 106 participants will be divided into 2 groups (53 each). Group A will receive scapular stabilizing exercises plus ergonomic educational leaflet for a period of 4 weeks, while group B will receive ergonomic educational leaflet only. Post intervention values of craniovertebral angle, grip strength and pinch strength will be recorded after a period of 4 weeks. The data will be analyzed using appropriate statistical tests. |