| CTRI Number |
CTRI/2024/10/075969 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Knee Brace to Assist and Correct funcation of the Knee Joint |
|
Scientific Title of Study
|
Therapeutic Knee Brace to Facilitate and Correct Movements of the Knee Joint |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahir Pooja Alabhai |
| Designation |
Post Graduate Student |
| Affiliation |
School Of Physiotherapy, RK University. |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
7016027174 |
| Fax |
|
| Email |
pahir305@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanshu V Rathod |
| Designation |
Professor, Dean, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK University, kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9426803108 |
| Fax |
|
| Email |
priyanshu.rathod@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanshu V Rathod |
| Designation |
Professor, Dean, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK University, kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9426803108 |
| Fax |
|
| Email |
priyanshu.rathod@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Research Department, Room no. 207, School of Physiotherapy, RK University, kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, pincode no:360020, Gujarat, india. |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy RK University |
| Address |
Research Department, Room no. 207,School of Physiotherapy, RK University,kasturbadham,Rajkot-Bhavnagar
Highway,Rajkot,pincode no: 360020,Gujarat,india. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ahir Pooja Alabhai |
Research Department, Room no. 207, School of Physiortherapy, RK
University, kasturbadham Rajkot-Bhavnagar Highway, Rajkot, pincode no: 360020, Gujarat, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Alabhai Ahir |
School of physiotherapy, RK Univbersity |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT |
7016027174
pahir305@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Knee Brace |
Therapeutic knee brace will be compared with conventional knee brace, focusing on their impact on knee movement and pain management in both healthy individuals and those experiencing knee pain.
Study Design: Participants, including both healthy individuals and those with knee pain, will undergo a single intervention session. Pre- and post-outcome measures will be taken after wearing each brace type to assess their effects on knee joint function and pain levels.
Outcome Measures: Time Up and Go test (TUG): For mobility and balance assessment. Numerical Pain Rating Scale (NPRS): To evaluate pain levels. Sit to Stand test: To measure lower limb strength and functional ability.
Intervention Frequency: Each participant will experience the intervention once, with outcome measures taken before and after wearing both the conventional knee brace and the therapeutic knee brace.
Duration of Intervention: Each session will last 20 minutes, including pre- and post-measurements for both types of knee braces.
Study Timeline: The study will be completed within one month.
|
| Intervention |
Therapeutic Knee Brace |
Study Objective:
This study aims to evaluate the effectiveness of a therapeutic knee brace in facilitating knee movement and reducing discomfort. The study will be conducted on both healthy individuals and those experiencing knee pain, assessing the impact of the therapeutic knee brace as compared to a conventional knee brace.
Outcome Measures:
Time Up and Go test (TUG): To assess mobility and balance.
Numerical Pain Rating Scale (NPRS): To evaluate pain levels.
Sit to Stand test: To measure lower limb strength and functional performance.
Study Design:
The study involves a single intervention for each participant. Pre- and post-outcome measures will be recorded after wearing both the innovative therapeutic knee brace and the conventional knee brace. Participants will include both healthy individuals and those with knee pain.
Frequency of Intervention:
Each participant will undergo the intervention once, with outcome measures taken before and after wearing each brace.
Duration of Intervention:
Each session will last 20 minutes, with pre- and post-measurements recorded for both knee braces.
Study Timeline:
The entire study will be completed within one month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals with knee pain, either unilateral or bilateral
2.Individuals who are Capable of performing basic physical activities (e.g., walking, climbing stairs).
3. Able to wear knee brace
|
|
| ExclusionCriteria |
| Details |
1. Individuals with cognitive disorders.
2. History of Hospitalisation in last 6 months
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale (NPRS) Scale.
|
With wearing therapeutic and conventional knee brace, before and after Numerical Pain Rating Scale (NPRS) will be performed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time up and Go (TUG) Test.
|
With wearing therapeutic and conventional knee brace, before and after TUG Test will be performed. |
| Sit to Stand |
With wearing therapeutic and conventional knee brace, before and after Sit to Stand test will be performed. |
|
|
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)
|
15/12/2024 |
| 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="3"
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
|
Therapeutic Knee Brace aimed at facilitating and correcting movements of the knee joint. The project will involve a two-stage study to assess its effectiveness on both healthy individuals and individuals with knee pain disorders with the tehrpautic knee brace and traditionally available knee brace.
Stage 1: Study on Healthy Individuals - Objective: To evaluate knee function in normal individuals under different conditions. - Method: Each participant will be assessed in three scenarios: 1. Without a knee brace (no external support). 2. Using the Conventional Knee Brace(the newly developed device). 3. Using a Therapeutic knee brace (standard brace available on the market).
Stage 2: Study on Individuals with Knee Pain Disorders - Objective: To evaluate the impact of the Therapeutic Knee Brace on individuals with existing knee pain or mobility issues. - Method: Each participant will be assessed under the same three conditions as in Stage 1: 1. Without a knee brace. 2. Using the Conventional Knee Brace. 3. Using a Therapeutic Knee Brace.
Outcome Measures For both stages of the study, the pre- and post-intervention results will be measured immediately after brace use, using the following tools: - Numerical Pain Rating Scale (NPRS): To assess pain levels. - Timed Up and Go (TUG) Test: To evaluate functional mobility and overall movement efficiency.
The results will help determine the effectiveness of the Therapeutic Knee Brace in improving knee function and managing pain, compared to no brace and a conventional brace. |