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CTRI Number  CTRI/2024/03/064014 [Registered on: 12/03/2024] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [PROSPECTIVE LONGITUDINAL STUDY]  
Study Design  Other 
Public Title of Study   Risk of fall after hip surgeries and role of fall prevention program 
Scientific Title of Study
Modification(s)  		 Identifying risk of fall in Geriatric patients who have undergone Total Hip Replacement and to study the efficacy of novel physiotherapeutic intervention on prevention of fall risk- A prospective longitudinal study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  DR MANOJ AGNIHOTRI PhD Scholar of School of Physiotherapy, D Y Patil Deemed to be University, Nerul West Navi Mumbai  
Designation  PRINCIPAL ,EX ASSOCIATE PROFESSOR 
Affiliation  Babandada Patil College of Physiotherapy and Terna Physiotherapy college 
Address  Babandada PT- Taloja phase 2 ,Dist. Raigad Navi Mumbai
Terna PT - 3RD Floor, Medical College Campus, sector 12, Nerul West Navi Mumbai
Raigarh
MAHARASHTRA
410208
India 
Phone    
Fax    
Email  manuagni1981@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Ajit Dabholkar PhD 
Designation  Professor & HOD Department of Sport Physiotherapy 
Affiliation  DY Patil Deemed to be University 
Address  School of Physiotherapy Sector 5 Nerul Navi Mumbai. Department - Sports Physiotherapy, 6 th floor

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9892502160  
Fax    
Email  ajit.dabholkar@dypatil.edu  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Ajit Dabholkar PhD 
Designation  Professor & HOD Department of Sport Physiotherapy 
Affiliation  DY Patil Deemed to be University 
Address  School of Physiotherapy Sector 5 Nerul Navi Mumbai, Department Sports Physiotherapy,6 th floor

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9892502160  
Fax    
Email  ajit.dabholkar@dypatil.edu  
 
Source of Monetary or Material Support  
Terna Hospital and DY Patil hospital, Nerul west, Navi Mumbai 
 
Primary Sponsor  
Name  Dr. MANOJ AGNIHOTRI 
Address  Terna Physiotherapy College Sect 12 Nerul west navi mumbai 
Type of Sponsor  Other [self] 
 
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 
Dr Manoj Agnihotri  DY Patil college of physiotherapy, nerul west  school of physiotherapy, 6 th floor ,DY Patil medical college campus, Nerul west , Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 7738621364

manuagni1981@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical and Health Research D. Y. Patil Deemed to be University School of Medicine, Navi-Mumbai  Approved 
Institutional Ethics Committee (IEC) for Biomedical and Health Research D. Y. Patil Deemed to be University School of Medicine, Navi-Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z471||Aftercare following joint replacement surgery, (2) ICD-10 Condition: Z96||Presence of other functional implants,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  fall prevention program  walking ,balance exercises and strength training exercises. 3 times a week for 6 weeks with 2sets of 10 repetitions  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria
Modification(s)  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details 
1. Geriatric patients aged 60 years or older, of either gender, who had undergone total hip replacement surgery 3 to 4 weeks before the commencement of the study.
2. Patients with no cognitive impairment, indicated by a Mini-Mental State Examination (MMSE) score greater than 26.
3. Patients who are willing to participate and provide informed consent.
 
 
ExclusionCriteria 
Details 
1. Patients who have undergone partial hip replacement instead of total hip replacement.
2. Patients with fractures of the femoral shaft managed with internal fixation procedures such as Dynamic Hip Screw (DHS) or Proximal Femoral Nail (PFN).
3. Patients with underlying or active hip infections (e.g., tubercular hip).
4. Patients with significant soft tissue injuries or conditions affecting the hip region.
5. Patients with fractures involving the acetabulum.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Fall Efficaly Scale, Haris Hip Scale, Timed Up And Go Test, Alternate Step Test, 5 times Sit To Stand Test   6 weeks 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Fall Efficaly Scale, Haris Hip Scale, Timed Up And Go Test, Alternate Step Test, 5 times Sit To Stand Test   6 weeks 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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   N/A 
Date of First Enrollment (India)   18/03/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [manuagni1981@gmail.com].

  6. For how long will this data be available start date provided 10-03-2024 and end date provided 20-02-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary
Modification(s)  		 In this study geriatric patients who had undergone THR post 4 weeks of surgery was taken. They were  assessed for fall risk screening through Haris hip score, fall efficacy scale and functional tests like timed up and go , alternate step test and 5 times sit to stand test. These same patients were assessed for same scales post 6 weeks and than after 12 weeks. Results were compared among different weeks of assessment and outcomes were co related with FES. Post their screening for fall risk; fall prevention program will be given to them for six weeks and again outcome will be re assessed. Fall prevention program will be mainly consisting of 5 domains - warm up, walking, strength, balance and cool down.; after every 2 weeks exercises will be progressed till 6 weeks . 10 rep and 2 sets of each exercises will be given with 2-3 min of interval. 
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