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

Sponsor
Delta University for Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05716529
Collaborator
(none)
50
1
2
13.8
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: rehabilitation protocol
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Functional Outcomes of a Criterion-based Rehabilitation Protocol for Anterior Cruciate Ligament Reconstruction in Amateur Athletes: a Randomized Clinical Trial
Actual Study Start Date :
Mar 6, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: accelerated rehabilitation protocol

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

Other: rehabilitation protocol
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

Active Comparator: conventional physical therapy program

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

Other: rehabilitation protocol
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

Outcome Measures

Primary Outcome Measures

  1. visual analogue scale [22 weeks]

    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

  1. Knee Injury and Osteoarthritis Outcome Score [22 weeks]

    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)

  2. limb symmetry index of Hop test battery [22 weeks]

    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

  3. knee effusion grading scale [22 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Delta university Gamasa Eldakahlyia Egypt

Sponsors and Collaborators

  • Delta University for Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omar Mohamed Ali Elabd, Lecturer of Orthopedics, Delta University for Science and Technology
ClinicalTrials.gov Identifier:
NCT05716529
Other Study ID Numbers:
  • 004257
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2023