| CTRI Number |
CTRI/2024/08/073135 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
effectiveness of graded motor imagery on pain, fear of movements, and walking pattern after total hip replacement: a randomized controlled trial |
|
Scientific Title of Study
|
Effectiveness Of Graded Motor Imagery On Pain, Kinesiophobia And Gait Parameters In Total Hip Replacement: A Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Kadolkar |
| Designation |
Postgraduate |
| Affiliation |
|
| Address |
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
6366173377 |
| Fax |
|
| Email |
Simrankadolkar770@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA |
| 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 |
| Dr Vijay Kage |
KLEs Dr. Prabhakar kore hospital and research centre |
KAHER INSTITUTE OF PHYSIOTHERAPY, DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY, OPD NO 39, ROOM NO 18, NEHRU NAGAR BELGAVI, KARNATAKA
Belgaum
KARNATAKA |
9845271899
vijaykage@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
Conventional treatment will be given for 5 sessions per week for 3 weeks. |
| Intervention |
Graded motor imagery and conventional treatment |
Graded motor imagery and conventional treatment will be given for 5 sessions per week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All genders within the age group of 40-75 years
Individuals in the acute phase of THR
Individuals who are capable of understanding commands and able to perform the exercises
Participants willing to participate |
|
| ExclusionCriteria |
| Details |
Individuals with neurological and Psychological disorders
History of previous trauma, lower limb fractures
Tumors, pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain using Numeric Pain Rating scale (NPRS)
Tampa scale for kinesiophobia Gait parameters |
Pain using Numeric Pain Rating scale (NPRS)
Tampa scale for kinesiophobia Gait parameters |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
16/09/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
EFFECTIVENESS OF GRADED MOTOR IMAGERY ON PAIN, KINESIOPHOBIA AND GAIT PARAMETERS IN TOTAL HIP REPLACEMENT: A RANDOMIZED CONTROLLED TRIAL Aim of the study - To determine the effect of graded motor imagery on pain, kinesiophobia and gait parameters in total hip replacement. Null hypothesis - There will be no change in the effect of graded motor imagery training on pain, kinesiophobia and gait parameters in total hip replacement Alternative hypothesis - There will be change in the effect of graded motor imagery training on pain, kinesiophobia and gait parameters in total hip replacement Inclusion criteria - 1. All genders within the age group of 40-75 years, 2.Individuals in the acute phase of THR. 3. Individuals who are capable of understanding commands and able to perform the exercises. 4.Participants willing to participate. Exclusion criteria - 1. Individuals with neurological and Psychological disorders. 2. History of previous trauma, lower limb fractures. 3.Tumors, pregnancy
|