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
|
|
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
|
|
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. 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. 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. |