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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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