| CTRI Number |
CTRI/2024/06/068412 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of pressure biofeedback training on quadriceps muscle strength and knee range of motion among people with total knee replacement |
|
Scientific Title of Study
|
Effect of pressure biofeedback training on quadriceps muscle strength and knee range of motion among people with total knee replacement: An Experimental 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 |
Molvika Mohan |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of Physiotherapy, Room no 20, Second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9035951758 |
| Fax |
|
| Email |
molvikam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy, Nitte (Deemed to be university) |
| Address |
Department of Physiotherapy, Room no 20, Second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy, Nitte (Deemed to be university) |
| Address |
Department of Physiotherapy, Room no 20, Second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy, NIITE (Deemed to be University) will provide the basic infrastructure facility, no other monitory support is required. |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room no 20, Second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018 India |
| Type of Sponsor |
Other [Constituent colleges of Nitte Institute of Physiotherapy, NITTE (Deemed to be University)] |
|
|
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 |
| DrNityal Kumar Alagingi |
Justice K S Hegde Charitable Hospital |
Department of Physiotherapy, Room no 20, Second base division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
7760547669
nityalkumar2020@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy, NITTE (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Pressure biofeedback training |
Pressure biofeedback training will be given for TKR patients from POD 1 till POD 7. Exercises include ankle toe movement, quadriceps isometric, hamstring isometric, gluteus isometric, hip abduction, short arc quadriceps, straight leg raise , ambulation with walker and pressure biofeedback training. Duration of intervention is 7 days. Frequency of exercise is 1-3 sets with 10 repetitions. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)TKR patients with post-operative day one will be included.
2)Participants from Justice K S Hegde Hospital Mangaluru.
|
|
| ExclusionCriteria |
| Details |
1)Presence of neurological signs.
2)A diagnosed psychiatric disorder or severe cognitive impairment.
3)Patients with bilateral TKR.
4)BMI of more than 24.9kg/m2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure biofeedback |
Pressure biofeedback readings will be taken at baseline and 1st week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Universal Goniometer |
It will be measured at baseline & 1st week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Total knee replacement is a surgical procedure for the end-stage knee osteoarthritis. Although total knee arthroplasty is widely regarded as effective at reducing knee pain, the surgery results in immediate and persistent deficits in lower extremity strength. It is estimated that pressure biofeedback training is effective in the activation of the quadriceps muscle in orthopedic surgeries. However, to date, the effect of pressure biofeedback training on early activation of quadriceps and knee range of motion in total knee replacement has not been reported. hence, the need for the study is to find out the effect of pressure biofeedback training on quadriceps muscle strength and knee range of motion among people with total knee replacement. |