| CTRI Number |
CTRI/2021/03/031623 [Registered on: 01/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
function and quality of life after supervised versus unsupervised rehabilitation program following total hip replacement |
|
Scientific Title of Study
|
Assessment of function and quality of life after supervised versus unsupervised rehabilitation program following unilateral uncomplicated total hip replacement: A randomized 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 |
Sankha Subhra Roy |
| Designation |
Post graduate trainee |
| Affiliation |
AIIMS, BBSR |
| Address |
Department of Physical Medicine and Rehabilitation,
Room number-5
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
Khordha
ORISSA
751019
India |
| Phone |
8617647945 |
| Fax |
|
| Email |
sankhasubhra.sankhasubhra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Apurba Barman |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, BBSR |
| Address |
Department of Physical Medicine and Rehabilitation
Room number-5
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
Khordha
ORISSA
751019
India |
| Phone |
9438884211 |
| Fax |
|
| Email |
pmr_apurba@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sankha Subhra Roy |
| Designation |
Post graduate trainee |
| Affiliation |
AIIMS, BBSR |
| Address |
Department of Physical Medicine and Rehabilitation,
Room Number-5
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
Khordha
ORISSA
751019
India |
| Phone |
8617647945 |
| Fax |
|
| Email |
sankhasubhra.sankhasubhra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Not applicable |
| Type of Sponsor |
Other [NIL ] |
|
|
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 |
| Sankha Subhra Roy |
PMR OPD |
Department of Physical Medicine and Rehabilitation
Room Number-5
All India Institute of Medical Sciences, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
Khordha
ORISSA |
8617647945
sankhasubhra.sankhasubhra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Supervised rehabilitation group |
Supervised rehabilitation program comprising of muscle strengthening exercises following total hip replacement surgery is taken as the comparator group |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 20 years and 65 years of age, of either sex , due to any diseases
2. No cognitive deficits
3. No neurological disorders |
|
| ExclusionCriteria |
| Details |
1. Neurological disorder
2. Hematological disorder, cardiac disorder, respiratory disease
3. Not willing to participate in all follow up
4. Operated outside
5. Cognitive deficits
6. Associated severe low back pain , knee joint pain
7. Developing complications after total hip replacement surgery
8. Revision total hip replacement surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the functional changes after supervised and unsupervised rehabilitation program following unilateral uncomplicated total hip replacement |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess quality of life after after supervised and unsupervised rehabilitation program following unilateral uncomplicated total hip replacement |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2021 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total hip replacement is an operative procedure conducted to treat an arthritic hip joint. Here the injured hip is replaced with an artificial implant. Following surgery the majr risk associated is the weakness of the muscles of the operated hip ; mainli the abductor muscles; which may lead to joint instability , loosening of prosthesis and other complications in the patient. Hence rehabilitation program emphasising strengthening exercises of muscles is recommended. Exercise program can be given in form of supervised institutional format or unsupervised home based format. However the high cost of supervised form of rehabilitation program limits the participation of of patients following post total hip replacement surgery. In our country till date no studies have been conducted to evaluate the efficacy of unsupervised form of rehabilitation program following unilateral uncomplicated total hip replacement surgery. hence we hypothesise that the unsupervised form of rehabilitation program will be equally effective as supervised form of rehabilitation program in improving the functional status and quality of life of the patients. |