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

Primary Purpose

Knee Ligament Injury, Anterior Cruciate Ligament Injuries

Status
Completed
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 Knee Ligament Injury

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Delta university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

criterion-based rehabilitation protocol

conventional physical therapy program

Arm Description

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

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 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)
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
NCT05719974
Brief Title
Functional Outcomes of a Criterion-based Rehabilitation Protocol for ACL Reconstruction in Amateur Athlete
Official Title
Functional Outcomes of a Criterion-based Rehabilitation Protocol for Anterior Cruciate Ligament Reconstruction in Amateur Athlete: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
January 7, 2023 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Ligament Injury, Anterior Cruciate Ligament Injuries

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
criterion-based rehabilitation protocol
Arm Type
Experimental
Arm Title
conventional physical therapy program
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
rehabilitation protocol
Intervention 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 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.
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
6 months
Secondary Outcome Measure Information:
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
6 months
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
6 months
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
6 months

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: 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.
Facility Information:
Facility Name
Delta university
City
Gamasa
State/Province
Eldakahlyia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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