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CTRI Number  CTRI/2025/08/093301 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
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   Early Physiotherapy exercises to treat the knee joint bleed in individuals with abnormal bleeding disorder in settings with less resources. 
Scientific Title of Study   Early Physical therapy intervention following acute knee joint bleed in persons with Haemophilia in resource limited settings. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Merlyn R 
Designation  Associate Professor 
Affiliation  Christian Medical College Vellore, 
Address  Physiotherapy Department, Christian Medical College, Vellore, 632002.

Vellore
TAMIL NADU
632002
India 
Phone  09444463948  
Fax  0416-2262788  
Email  merlyntilak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Andrew Babu 
Designation  Professor 
Affiliation  Christian Medical College Vellore, 
Address  Physiotherapy Department, Christian Medical College, Vellore, 632002.

Vellore
TAMIL NADU
632002
India 
Phone  09489590360  
Fax  0416-2262788  
Email  andrewb@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Merlyn R 
Designation  Associate Professor 
Affiliation  Christian Medical College Vellore, 
Address  Physiotherapy Department, Christian Medical College, Vellore, 632002.

Vellore
TAMIL NADU
632002
India 
Phone  09444463948  
Fax  0416-2262788  
Email  merlyntilak@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore  
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  The Institutional Review Board, Silver (Research and Ethics Committee) of the Christian Medical College, Vellore - 632 002 
Type of Sponsor  Other [Fluid Research Grant] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aby Abraham  Christian Medical College, Vellore  Haematology Department, Christian Medical College, Vellore, 632002.
Vellore
TAMIL NADU 
09443433024
0416-2262788
aby@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD CHRISTIAN MEDICAL COLLEGE THORAPADI POST BAGAYAM VELLORE Vellore Tamil Nadu - 632012 India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D66||Hereditary factor VIII deficiency, (2) ICD-10 Condition: D67||Hereditary factor IX deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy (Graded Physiotherapy)  Graded PT will include isometric exercises 10 repetitions for 3 sets per session for 6 days a week, multiangled isometrics for 5 seconds hold at every 5 degrees in the available range for 5 repetitions, 6 days a week , concentric and eccentric exercises and closed and open kinematic chain exercises for 10 repetitions with 10 seconds hold progressing from 1 set per week to 2 sets in the second week, 6 days per week, and progressive gait training.  
Intervention  Hold -relax technique  During the Hold-relax intervention, the limb will be taken to the end of the available range and the patient instructed to ‘hold’ the position for 10 seconds whilst the physiotherapist applies resistance to build up a maximal isometric contraction in the muscle group that requires lengthening. Following this maximal contraction the instruction to relax will be given whilst the limb is fully supported to allow maximal relaxation for 10 seconds. The limb will then be taken to the new end of range and the technique repeated 10 times for 3 sets per session and continued for 6 days a week. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Severe Haemophilia A or B,
Patients with a unilateral acute knee joint bleed

 
 
ExclusionCriteria 
Details  Haemophilia A and B with inhibitor
Fixed flexion deformity in the knee joint before the bleed
Previous surgeries including TKR, THR, osteotomies
Muscle haematomas or other joint bleeds on the same lower limb
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Knee Range of motion

 
Pre-bleed
Day of joint bleed
14 days post- bleed
3 month follow-up
 
 
Secondary Outcome  
Outcome  TimePoints 
Muscle power – Modified Oxford scale for Manual Muscle
testing, Dynamometer.
Joint Health – Haemophilia joint health score (HJHS)
Ambulation – Functional Mobility Scale (FMS)
Pain – Visual Analogue Scale (VAS score)
Swelling–Circumferential measurement using inch tape.
 
Pre-bleed
Day of joint bleed
14 days post- bleed
3 month follow-up
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 3 
Date of First Enrollment (India)   01/11/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [merlyntilak@gmail.com].

  6. For how long will this data be available start date provided 01-08-2030 and end date provided 01-08-2040?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Patients with acute knee joint bleed will be assessed for eligibility and included in the study after a written consent. They will be evaluated by the Principal Investigator (PI) for acute joint bleed symptoms. When the patient is clinically diagnosed with acute bleed, they will be given clotting factor replacement therapy following which patient will be sent for Ultrasound for confirmation of diagnosis. Following ultrasound, patients will be taught POLICE protocol (Protection, Optimal Loading, Ice, Compression and Elevation) and asked to come for therapy the following day. They will be evaluated for movement and pain in the affected joint every day. If the patient is able to move the joint in the mid-range without pain and the pain on Visual Analogue Score (VAS) has reduced to less than 4/10, they will be included for graded Physiotherapy (PT). The number of days taken to start the graded PT will be taken as optimal rest period following knee joint bleed.

Before starting graded PT, a baseline assessment will be done by the physical therapist (Outcome assessor) who will be blinded to the group allocation. The assessment will include measurement of pain using VAS scale, swelling using inch tape, knee flexion and extension range using a universal goniometer and an accelerometer, muscle power using Modified Oxford scale for manual muscle testing, joint health using Haemophilia Joint Health Score (HJHS) and ambulatory status using functional mobility scale. Following this, the patients will be randomized using sequentially numbered, opaque, sealed envelope (SNOSE) to two groups. Physical therapy intervention for the two groups will be given by the PI. The interventional group will receive Hold-Relax technique along with 2 weeks of graded PT. The control group will receive only 2 weeks of graded PT. Graded PT will include isometric exercises, multiangled isometrics, static stretching, concentric and eccentric exercises, closed and open kinematic chain exercises and progressive gait training.

At the end of 2 weeks, the outcomes will be re-assessed by the physical therapist (blinded outcome assessor). The data will be analyzed to find out if addition of Hold-relax technique to a 2 – week graded physiotherapy program helped in improving the joint range of motion when compared to the control group. A follow-up assessment will be done at 3 months to re-assess the outcomes and to find out if there were any re-bleeds. In addition, the correlation between clinical and ultrasound diagnosis of acute knee joint bleed; the impact of cryotherapy on pain and duration of rest period; and optimal time for rest following acute knee joint bleed will also be analyzed.

 
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