| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - None of the above
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [merlyntilak@gmail.com].
- 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.
- 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. |