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CTRI Number  CTRI/2024/02/062726 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening
Other (Specify) [PROSPECTIVE LONGITUDINAL STUDY]  
Study Design  Other 
Public Title of Study   RISK OF FALL AFTER HIP SURGERIES AND TO KNOW THEIR PREVENTIVE TREATMENT PLAN  
Scientific Title of Study   “Identifying risk of fall in Geriatric patients with Hip impairment and to study the efficacy of 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)  
Name  DR MANOJ AGNIHOTRI 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Terna physiotherapy college 
Address  DEPARTMENT-Musculoskelertal physiotherapy in Terna Physiotherapy College
Office Address - TPC, 3RD Floor at Terna Medical College Campus, Sector 12 Phase 2, Nerul West Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400607
India 
Phone  7738621364  
Fax    
Email  manojagnihotri@ternapt.ac.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Ajit Dabholkar PhD 
Designation  Professor & HOD Department of Sport Physiotherapy 
Affiliation  DY Patil School of Physiotherapy 
Address  DY Patil Deemed to be University, School of Physiotherapy Sector 5 Nerul Navi Mumbai
DY Patil Deemed to be University, School of Physiotherapy Sector 5 Nerul Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  09892502160  
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 School of Physiotherapy 
Address  DY Patil Deemed to be university, School of physiotherapy, Sect 5 , Nerul Navi Mumbai
DY Patil Deemed to be university, school of physiotherapy, Sect 5 , Nerul Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9892502160  
Fax    
Email  ajit.dabholkar@dypatil.edu  
 
Source of Monetary or Material Support  
DY Patil school of Physiotherapy, Nerul, Navi Mumbai . Terna Physiotherapy College, Nerul ,Navi Mumbai 
 
Primary Sponsor  
Name  manoj agnihotri 
Address  flat no 803 E -2 rutu tower GB road thane west maharashtra 400607 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajit Dabholkar  DY Patil school of physiotherapy, Terna physiotherapy college  Musculoskeletal dept. DY Patil School of Physiotherapy Sector 5 Nerul Navi Mumbai, Terna Physiotherapy College Musculoskeletal dept, sect 12,nerul west Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 9892502160

ajit.dabholkar@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M970||Periprosthetic fracture around internal prosthetic hip joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FALL PREVENTION PROGRAM  3 Times A Week For 20 Mins-With 10 Rep  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.60 years and above both male and female geriatric population with or without hip pain who had undergone Total or partial hip replacement surgeries, proximal femoral nailing surgeries and dynamic hip compression screw surgeries
.2. Healthy Geriatric subjects of 60 years and above
3. Geriatric patients/subjects with no cognitive impairment -MMSE scale Score should be more than 26.
4. Geriatrics patients/subjects who are willing to participate
5. Geriatrics patients should be shown readiness for discharge on Readiness to hospital discharge scale(RHDS)
 
 
ExclusionCriteria 
Details  1. Any Neurological impairments like stroke, paraplegia.
2. Fractures shaft of femur.
3. Diagnosed Musculoskeletal problems of spine (radiating pain), knee and ankle
4. Soft tissues problems of hip like meralgia paresthesia, overuse syndromes of hip – tendinitis, muscle pull, ischiogluteal bursitis, psoas bursitis
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fall Efficaly Scale, Haris Hip Scale, Timed Up And Go Test, Alternate Step Test, Sit To Stand Test   4 weeks and 8weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Fall Efficaly Scale, Haris Hip Scale, Timed Up And Go Test, Alternate Step Test, Sit To Stand Test   Patients Will be assessed after 4 weeks & 8 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)   05/03/2024 
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="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Suspended 
Recruitment Status of Trial (India)  Suspended 
Publication Details   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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  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 02-10-2025 and end date provided 02-10-2030?
    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 - nil
Brief Summary
Modification(s)  		 The Geriatric population will be divided into 3 groups.      Group A who had undergone THR or Partial hip replacement surgeries, Group B who had undergone DHS and PFN surgeries and Group C who are healthy.                                  Various outcome measures like Haris hip scale, Fall efficacy scale, Functional tests like - Timed up and go test, Alternate step test and Sit to stand test will be performed to know about their risk of fall. After screening them for fall risk they will be given fall prevention program for 8 weeks. After 4 weeks than 8 weeks they will be assessed again for fall risk. 
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