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Functional Outcomes of an Accelerated Rehabilitation Protocol for ACL Reconstruction in Amateur Athletes (ACL)

Primary Purpose

ACL Injury, Rehabilitation After ACL Reconstruction, Accelerated Protocol

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
rehabilitation protocol
Sponsored by
Delta University for Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Patients were participated in this study if they fulfilled the following criteria: Underwent pre-operative rehabilitation program with minimal knee effusion and full extension, good patellofemoral mobility, and the patient can actively control the quadriceps. Have an ACLR with an autolongous hamstring (HT) graft. Age range from 18-40 years old. Football players or who perform physically demanding work. Have no other ligamentous injury. Have nomeniscectomy previous to or simultaneouswith ACLR. Have no cartilage damage. Exclusion Criteria: • Patients younger than 18 or older than 35 years old Have ACLR with any graft other than hamstring (HT) graft Have ACL revision surgery Have other ligamentous injury Have a meniscectomy previous to or simultaneous with ACLR. Had meniscal repair simultaneously with ACLR Have cartilage damage.

Sites / Locations

  • Delta university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

accelerated rehabilitation protocol

conventional physical therapy program

Arm Description

It's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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

Full Information

First Posted
January 28, 2023
Last Updated
February 8, 2023
Sponsor
Delta University for Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05716529
Brief Title
Functional Outcomes of an Accelerated Rehabilitation Protocol for ACL Reconstruction in Amateur Athletes
Acronym
ACL
Official Title
Functional Outcomes of a Criterion-based Rehabilitation Protocol for Anterior Cruciate Ligament Reconstruction in Amateur Athletes: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main goal of a rehabilitation program after an ACL reconstruction is to regain mobility and muscle function and ultimately to return to sports participation. Purpose of the study: to investigate the effect of the accelerated rehabilitation program on knee pain, and function in patients post ACLR surgery. Fifty adult amateur males athletes who underwent ACLR surgery participated in this study, their age ranged from 18 to 35years.They were randomly assigned into two equal groups. Group (A) received accelerated rehabilitation protocol and group (B) received conventional physical therapy program. Treatment sessions were conducted 5 times per week for 22 weeks for both groups. All patients assessed pre and post treatment for pain intensity using visual analogue scale (VAS), and knee function using knee injury and osteoarthritis outcome score (KOOS), knee effusion, and LSI of Hop test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, Rehabilitation After ACL Reconstruction, Accelerated Protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
accelerated rehabilitation protocol
Arm Type
Experimental
Arm Description
It's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises
Arm Title
conventional physical therapy program
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
rehabilitation protocol
Intervention Description
It's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises
Primary Outcome Measure Information:
Title
visual analogue scale
Description
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
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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)
Time Frame
22 weeks
Title
limb symmetry index of Hop test battery
Description
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
Time Frame
22 weeks
Title
knee effusion grading scale
Description
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
Time Frame
22 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients were participated in this study if they fulfilled the following criteria: Underwent pre-operative rehabilitation program with minimal knee effusion and full extension, good patellofemoral mobility, and the patient can actively control the quadriceps. Have an ACLR with an autolongous hamstring (HT) graft. Age range from 18-40 years old. Football players or who perform physically demanding work. Have no other ligamentous injury. Have nomeniscectomy previous to or simultaneouswith ACLR. Have no cartilage damage. Exclusion Criteria: • Patients younger than 18 or older than 35 years old Have ACLR with any graft other than hamstring (HT) graft Have ACL revision surgery Have other ligamentous injury Have a meniscectomy previous to or simultaneous with ACLR. Had meniscal repair simultaneously with ACLR Have cartilage damage.
Facility Information:
Facility Name
Delta university
City
Gamasa
State/Province
Eldakahlyia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional Outcomes of an Accelerated Rehabilitation Protocol for ACL Reconstruction in Amateur Athletes

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