| CTRI Number |
CTRI/2026/01/100749 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Developing and Testing a Smart AI-Based Mobile App for Safe and Effective Neck Exercises |
|
Scientific Title of Study
|
Development, Validation and Application of an Artificial Intelligence and Augmented Reality-Powered Mobile App for neck exercise prescription |
| 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 Juhi Bharnuke |
| Designation |
Associate Professor, PhD Scholar |
| Affiliation |
SCHOOL OF PHYSIOTHERAPY, D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
6TH FLOOR, DEPARTMENT OF MUSCULOSKELETAL PHYSIOTHERAPY, SCHOOL OF PHYSIOTHERAPY, D Y PATIL DEEMED TO BE UNIVERSITY, SECTOR 5, NERUL EAST, NAVI MUMBAI 400706
Thane MAHARASHTRA 400706 India |
| Phone |
09167680099 |
| Fax |
|
| Email |
juhi.bharnuke@dypatil.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Juhi Bharnuke |
| Designation |
Associate Professor, PhD Scholar |
| Affiliation |
SCHOOL OF PHYSIOTHERAPY, D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
6TH FLOOR, DEPARTMENT OF MUSCULOSKELETAL PHYSIOTHERAPY, SCHOOL OF PHYSIOTHERAPY, D Y PATIL DEEMED TO BE UNIVERSITY, SECTOR 5, NERUL EAST, NAVI MUMBAI 400706
Thane MAHARASHTRA 400706 India |
| Phone |
09167680099 |
| Fax |
|
| Email |
juhi.bharnuke@dypatil.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Twinkle Dabholkar |
| Designation |
Professor, PhD Guide |
| Affiliation |
SCHOOL OF PHYSIOTHERAPY, D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
6TH FLOOR, DEPARTMENT OF MUSCULOSKELETAL PHYSIOTHERAPY, SCHOOL OF PHYSIOTHERAPY, D Y PATIL DEEMED TO BE UNIVERSITY, SECTOR 5, NERUL EAST, NAVI MUMBAI 400706
Thane MAHARASHTRA 400706 India |
| Phone |
9819870821 |
| Fax |
|
| Email |
twinkle.dabholkar@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Testing of newly developed mobile app will be done using accelorometer provided by School of Physiotherapy, D Y Patil deemed to be University. Additionally, cost of testing on patients and overhead costs would be borne by School of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy, D Y Patil deemed to be University |
| Address |
y Patil University, Plot 1-E, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Mumbai, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| JUHI BHARNUKE |
D Y PATIL HOSPITAL AND RESEARCH CENTRE |
OPD NO. 29, GROUND FLOOR, D Y PATIL HOSPITAL AND RESEARCH CENTRE, D Y PATIL VIDYANAGAR, SECTOR 5, NERUL EAST, NAVI MUMBAI 400706 Thane MAHARASHTRA |
09167680099
juhi.bharnuke@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neck exercises delivered through mobile app for a period of 6 weeks |
Exercises for mechanical neck pain will be provided by mobile app along with conventional physiotherapy treatment for a period of 6 weeks. |
| Comparator Agent |
Neck exercises delivered via videos of exercises sent to the patients with mechanical neck pain. |
Neck exercises delivered via videos of exercises sent to the patients with mechanical neck pain along with conventional physiotherapy exercises will be done for a period of 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with mechanical neck pain with NPRS less than 4 on 10, both males and females, patients who can follow basic English commands, and patients with Android or iOS phones. |
|
| ExclusionCriteria |
| Details |
Patients with history neck or shoulder surgery, contra-indication to stretching, Rheumatoid arthritis, cervicogenic headache, spine infection, malignancy, trauma, fracture of cervical spine vertebrae in the last 6 months, Patients with symptoms of cervical radiculopathy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain: Numerical Pain Rating Scale, The NPRS is a segmented numeric version of the pain rating scale in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The NPRS was shown to be highly correlated with the VAS in patients with chronic low back pain: correlations range from 0.86 to 0.95.
2. Disability: Neck Disability Index: It is a valid and reliable tool used for assessing neck function in patients with neck pain.
|
At baseline, 3 weeks, 6 weeks and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| System Usability Scale will be used to record user experience of mobile app. |
At baseline and at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
05/01/2027 |
| 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="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
|
|
Brief Summary
|
Prior to participation, a signed informed consent form will be collected from each participant. A baseline evaluation will be conducted to assess initial clinical parameters. Participants will then be randomly allocated into two groups using a computerized randomization method. Group A will receive cervical rehabilitation exercises through a mobile application, whereas Group B will receive only video-based instructional intervention for the same duration. In addition to their respective exercise programs, both groups will receive two supervised contact physiotherapy sessions per week for the first four weeks, followed by one supervised session per week for the remaining two weeks, completing a total supervised intervention period of six weeks. At the end of this 6-week intervention period, all participants will be assessed for pain using the Numeric Pain Rating Scale, cervical function using the Neck Disability Index, and intervention usability using the System Usability Scale. An intermediate assessment will also be carried out at the third week of intervention, and participants will undergo a long-term follow-up assessment after six months to evaluate sustained effects. Upon completion of intervention, outcomes from both groups will be statistically analyzed to compare the effects of the two delivery methods. An independent t-test will be used to analyze between-group differences using SPSS software, version 23, IBM Inc., Armonk, NY. |