Functional Outcomes of a Criterion-based Rehabilitation Protocol for ACL Reconstruction in Amateur Athlete

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Functional Outcomes of a Criterion-based Rehabilitation Protocol for Anterior Cruciate Ligament Reconstruction in Amateur Athlete: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719974
• Other study ID #: Deltau
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: January 7, 2023

Study information

• Verified date: January 2023
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 7, 2023
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft.

• Ranging in age from 18 to 35 years.

• Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility

• Ability to actively control the quadriceps.

Exclusion Criteria:

• ACLR with any graft other than a hamstring graft

• ACL revision surgery

• associated medial or lateral ligamentous injuries

• previous meniscectomy or meniscal repair

• simultaneous meniscectomy or meniscus repair with the ACLR

• cartilage damage.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Knee Ligament Injury
• Wounds and Injuries

Intervention

Other:
• rehabilitation protocol
Current conventional protocols were based mainly on biological tissue healing time frames. These protocols emphasize pain reduction, full passive knee extension, quadriceps strength training, immediate motion, immediate par¬tial weight bearing (only if there is a correct gait pattern without any complications), and functional exercises The criterion-based rehabilitation protocol is relatively new. It was developed and recommended in 2016 by the Royal Dutch Society for Physical Therapy (KNGF), aiming to assure a more patient-tailored rehabilitation and to maximize the speed of a patient's progress. It's a three phases protocol with a criterion-based progression.

Locations

Country	Name	City	State
Egypt	Delta university	Gamasa	Eldakahlyia

Sponsors (1)

Lead Sponsor	Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	It is a 100-mm horizontal line anchored by word descriptors at each end by "no pain" on the left and "worst imaginable pain" on the right	6 months
Secondary	limb symmetry index of hop test battery	The mean score of the results of each item of hop test battery of the injured limb was divided by the corresponding mean score of the uninjured limb and the result was multiplied by 100. Hop test battery consists of the following: (1) vertical jump, (2) hop for distance, (3) drop jump followed by a double hop for distance, (4) square hop and (5) side hop.	6 months
Secondary	Knee Injury and Osteoarthritis Outcome Score	it is a 42-item self-questionnaire with five subscales. A five-point scale ranging from 0 (no problem) to 4 (extreme problems) was used to score each item and the scores of each subscale were individually transformed into a 0-100 scale (0 = extreme knee problems, 100 = no knee problem)	6 months
Secondary	knee effusion grading scale	It"s a reliable and valid method which Based on a stroke test, where effusion of the knee joint is quantified using a 5-point scale. A 0 grade means no wave is produced with the downward stroke	6 months