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CTRI Number  CTRI/2018/08/015473 [Registered on: 27/08/2018] Trial Registered Prospectively
Last Modified On: 24/08/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [Telerehabilitation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Telerehabilitation versus conventional Physical therapy rehabilitation in Hip pathology 
Scientific Title of Study   Telerehabilitation versus conventional Physical therapy rehabilitation in people with Hip pathology– A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha P Shenoy 
Designation  Assistant Professor 
Affiliation  KMC Manipal University, Mangalore  
Address  KMC Bejai, Center of Basic sciences, Department of Physiotherapy, Mangalore, 575001
B5, KMC Staff Quarter. Light House Hill Road
Dakshina Kannada
KARNATAKA
575001
India 
Phone  08792480796  
Fax    
Email  paraimanisha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manisha P Shenoy 
Designation  Assistant Professor 
Affiliation  KMC Manipal University, Mangalore  
Address  KMC Bejai, Center of Basic sciences, Department of Physiotherapy, Mangalore, 575001
B5, KMC Staff Quarter. Light House Hill Road

KARNATAKA
575001
India 
Phone  08792480796  
Fax    
Email  paraimanisha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manisha P Shenoy 
Designation  Assistant Professor 
Affiliation  KMC Manipal University, Mangalore  
Address  KMC Bejai, Center of Basic sciences, Department of Physiotherapy, Mangalore, 575001
B5, KMC Staff Quarter. Light House Hill Road

KARNATAKA
575001
India 
Phone  08792480796  
Fax    
Email  paraimanisha@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical college, Mangalore 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education KMC Mangalore 
Address  KMC Mangalore, Light House Hill Road, Mangalore 575001 
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 
Manisha P Shenoy  KMC Hospitals  Department of Physiotherapy, Attavar, Mangalore
Dakshina Kannada
KARNATAKA 
8792480796

paraimanisha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Face to face follow up  Usual care of hip rehabilitation for the follow up will be provided once a week for 6 weeks. At each follow-up for both control (FF) and experimental (TR) group, the physiotherapist will be recording their outcome measure of NPRS. HOOS will be recorded at the last follow-up session and Quality of life SF36 will be scored of all patients 4 weeks after Physical Therapy discharge in the same application. Patient will be called face to face for both the groups for a final assessment recording the baseline parameters again by a blinded assessor.  
Intervention  Telerehabilitation  The experimental group will be given a training session with the use of the application to make them acquainted to the technology. A written flowchart as a guide will also be provided to them for future reference. A username and password will be generated for them which will be used for the login process. Patients will log in with the generated username and password, agree to the standard terms and conditions of the application and then book an appointment (once a week for 6 weeks) for their follow-up session. As per the scheduled appointment when they login, the video conference will start. After the videoconference session, they will have guided pathway in the application to provide their satisfaction feedback (objective checklist), and will be then redirected to booking the next appointment. The schedule to the next appointment will be either suggested by the therapist, or it will be as per patient’s availability. At each follow-up for both control (FF) and experimental (TR) group, the physiotherapist will be recording their outcome measure of NPRS. HOOS will be recorded at the last follow-up session and Quality of life SF36 will be scored of all patients 4 weeks after Physical Therapy discharge in the same application. Patient will be called face to face for both the groups for a final assessment recording the baseline parameters again by a blinded assessor.  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
Patients with the following conditions will be included for the study.
1 Fracture around the hip referred for Physical Therapy (Head of femur, intertrochanteric, neck of femur, actetabular, shaft of femur, Pelvic girdle)
2 Fracture around the hip surgically managed
3Patients with the ability to comprehend English language (read and understand)
 
 
ExclusionCriteria 
Details  Exclusion Criteria
Patients with the following conditions will not be included in the study.
1 Poly trauma cases with the involvement of multiple joints and bones
2 Inability to comprehend command
3 Does not have internet connection either in phone or computer
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
NPRS
Assessment of ROM and strength of the region
HOOS
SF36
Self-made satisfaction questionnaire for treatment and application use 
NPRS at every visit
Assessment of ROM and strength of the region, begining and end of 6 weeks intervention
HOOS at the end of 6 weeks intervention
SF36 4 weeks after the 6 weeks intervention
Self-made satisfaction questionnaire for treatment and application use 6 weeks after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
cost of treatment
cost of travel
cost of internet use 
end of study which is 6 weeks from the start 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/06/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Telerehabilitation has proven its effectiveness in stroke, cardiovascular diseases and some musculoskeletal conditions. There is dearth in literature exploring the effect of telerehabilitation in India and in patients with hip conditions.   

Telerehabilitation on its own is not a complete solution to rehabilitation unless it utilises the innovative way in the process of its application. Active participation of client in such rehabilitation process leads to success. Therefore the study would like to develop an application which would guide clients to access telerehabilitation.

Need of the study

Therefore, there is a need to

·         Establish an application system in the hospital website where patients may login with minimal payment to seek advice and show progress of their follow –up rehabilitation to the therapist.

·         Establish online documentation tool to record data

·         To find the effectiveness of TR in cases of rehabilitation following hip fracture, as the rehabilitation timespan is more, and the face to face follow up is sometimes not possible after discharge from hospital for such population category.

IV. Objectives

Phase 1

            Primary objective

1.    To develop an application ‘MeRRA’ (Manipal e-rehab remote access) which will be compatible to windows, android and mac version to allow pathway to video conferencing

Secondary objective

1.    To create online documentation tool for orthopaedic in-patient and outpatient Physical Therapy department.

Phase 2

Primary objective

1.    To measure the effectiveness of TR in fractures around hip

Secondary Objective

  • To monitor patients progress with outcome measures
  • To record satisfaction level using the application
  • To perform its Cost-effectiveness and cost-benefit analysis


The application if proven to be satisfying to patients and therapist, it will be a useful tool to monitor patients progress which is otherwise hindered in rehabilitation. Clients who find it difficult to come to hospital for a follow-up visit usually does not come for follow up or they delay the follow up unless any fresh complaint start. This application will help therapist monitor patient and advice accordingly. The documentation will be a useful tool as the checklist will not let components of assessment get missed by therapist. The data can be used in a period of time to do retrospective analysis and derive conclusion for the betterment of the profession and client.

The application will be cost effective comparing it to face to face consultation. Each consultation visit will amount not more than rupee 80. The cost approximation is made taken into consideration that in a month we will be expecting 250 clients for the same. The actual cost a patient bear for a consultation as an OPD or IPD care which is usually a minimum of rupee 100 to 150 per visit. Physical Therapy rehabilitation involves multiple session of interaction. The visit to a hospital also includes the transportation cost and the time involved in the travel. If such issues are taken care of by having a session of therapy or consultation at home, then the people of the country will be able to afford such health care.

When the cost of healthcare is reduced to half with similar advantages, we hypothesise that people will be more actively involved in rehabilitation and health care. 
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