Effect of Blood Flow Restriction Technique After Anterior Cruciate Ligament Reconstruction

NCT06437470 | Completed

• 1 other identifier: P.T.REC/012/005176
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study will be to evaluate the effect of adding BFR (using 80% of LOP) to the conventional physical therapy program on knee function, functional test, balance, quadriceps and hamstrings muscles strength, thigh muscle girth and knee effusion in rehabilitation after ACLR.

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (4)

• knee function

  will be assessed by the Arabic version of the knee outcome survey-activities for daily living scale. It encompasses six questions addressing restrictions in daily activities caused by symptoms like pain, swelling, and instability, and eight questions evaluating difficulties in functional tasks such as walking, stair climbing, and sitting or standing up from a chair. Each question is rated on a 6-point Likert scale. Scores range from 0 to 70, with higher scores indicating better functional capacity.

  after 3 months of intervention

• knee functional test

  will be assessed by the single leg hop test

  after 3 months of intervention

• balance

  will be assessed by the Y balance test for the lower quarter

  after 3 months of intervention

• quadriceps and hamstring muscles strength

  will be assessed by the hand held dynamometer

  after 3 months of intervention

Secondary Outcomes (2)

• Thigh muscle girth

  baseline then 3 months after intervention

• Knee effusion

  baseline then 3 months after intervention

Study Arms (2)

conventional physical therapy program

SHAM COMPARATOR

participants will receive the conventional physical therapy program while using non-inflated cuff as a sham treatment during exercising.

Other: blood flow restriction technique

blood flow restriction combined to conventional physical therapy program

EXPERIMENTAL

participants will receive the conventional physical therapy program with the use of BFR cuff which will be inflated to reach 80% of limb occlusive pressure

Other: blood flow restriction technique

Interventions

blood flow restriction technique OTHER

All participants in the control group will receive the conventional physical therapy program with the use non-inflated cuff as a sham treatment during exercising. All participants in the intervention group will receive the conventional physical therapy program combined to blood flow restriction to 80% of limb occlusive pressure by using blood flow restriction cuff.

blood flow restriction combined to conventional physical therapy program; conventional physical therapy program

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged from 18-35 years.
• Underwent an ACLR semitendinosus autograft one-week post-operative
• Willingness to participate in the intervention and subsequent assessment.
• BMI from 18.5 to 29.9 kg/m2.

You may not qualify if:

• Insecure graft fixation (due to bone quality, suspension).
• Active infection.
• Postsurgical excess knee swelling that may limit exercise performance.
• ACLR using bone tendon bone (BTB) graft.
• Any cardiovascular disease such as hypertension.
• Any lower limb trauma.
• Hip and ankle pathology.
• BMI more than 30 kg/m2

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy - Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Enas F Youssef, Professor

  Prof. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University

  STUDY CHAIR

• Dina S Abd Allah, lecturer

  Lec. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University

  STUDY DIRECTOR

• Ahmed S Elkalyoby, Asst. prof

  Asst. prof. of orthopedic surgery, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: a single-blinded design, ensuring that the research assistant (who serves as the examiner for all patients) and the statistician are blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Physical Therapy for Musculoskeletal System Disorders and its Surgery, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: May 31, 2024
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

EG (1)