| CTRI Number |
CTRI/2025/04/084983 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Does Blood Flow Restriction Therapy Reduce Pain and Improve Mobility and Muscle Strength After ACL Surgery? |
|
Scientific Title of Study
|
Effectiveness of Practical Blood flow restriction training on Muscle strength, pain and Physical functionality in ACL reconstruction rehabilitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Bhal |
| Designation |
Student |
| Affiliation |
Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun |
| Address |
Shri Guru Ram Rai Institute of Medical and Health Sciences, Department of Physiotherapy, North Block, Basement, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7505088869 |
| Fax |
|
| Email |
bhalprachi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Niraj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun |
| Address |
Shri Guru Ram Rai Institute of Medical and Health Sciences, Department of Physiotherapy, North Block, Basement, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tabassum PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun |
| Address |
Shri Guru Ram Rai Institute of Medical and Health Sciences, Department of Physiotherapy, North Block, Basement, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
drtabassumazm22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun, 248001, India |
|
|
Primary Sponsor
|
| Name |
Prachi Bhal |
| Address |
40 Rispana Road, Workshop wali gali, Karanpur, Dehradun |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prachi Bhal |
Shri Mahant Indresh Hospital, Patelnagar, Dehradun, 248001 |
Shri Mahant Indresh Hospital, Department of Physiotherapy, North Block, Basement, 248001
Dehradun
UTTARANCHAL |
7505088869
bhalprachi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional resistance training |
Conventional resistance training at moderate intensity, 70 percent of 1RM |
| Intervention |
Practical Blood flow restriction training |
Exercise based training protocol involving application of external compression on the exercising limb with non pneumatic bands while performing low intensity exercise |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
underwent ACL reconstruction
autologous tendon graft
1-4 months post surgery
unsupported unilateral weight bear without pain for at least 5 secs
repeated straight leg raise without knee extension muscle lag
No contralateral leg injury in at least 12 months
Minimum active ROM of 100 degrees in operated knee
|
|
| ExclusionCriteria |
| Details |
Pregnancy
History of deep vein thrombosis
Congenital heart disease
varicose veins
Rheumatoid arthritis
COPD
Hypothyroidism |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Handheld dyanamometer
2.IKDC
3.Lysholm score
4.NPRS |
baseline, week 4th, week 8th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
29/04/2025 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
This study aims to determine the therapeutic benefits of Practical Blood Flow Restriction (pBFR) training as an intervention for improved strength development combined with reduced pain symptoms and enhanced physical abilities for patients doing post-ACL reconstruction rehabilitation. The research evaluates how pBFR affects pain scores and functional outcomes and measures knee muscle strength in comparison to basic exercises without BFR usage. The study addresses existing problems with BFR methods because they contain high costs and restricted availability by offering practical and economic alternatives through elastic band usage. The study proposes that Practical Blood Flow Restriction (pBFR) delivers substantial pain relief and muscle strength improvement (H1) versus the negative statement that claims no substantial benefits (H0). |