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CompletedNCT05719974Updated Feb 9, 2023

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

An interventional study of rehabilitation protocol in Knee Ligament Injury and Anterior Cruciate Ligament Injuries, sponsored by Delta University for Science and Technology. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by Delta University for Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Mar 2020, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Knee Ligament Injury
  • Anterior Cruciate Ligament Injuries
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In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 50 is close to the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Delta University for Science and Technology is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    criterion-based rehabilitation protocol

    Other: rehabilitation protocol

  • Active comparator
    conventional physical therapy program

    Other: rehabilitation protocol

Interventions

  • Otherrehabilitation 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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)

    Time frame: 6 months

  3. 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

    Time frame: 6 months

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Study locations

1 site
  • Delta university
    Gamasa, Eldakahlyia, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05719974
Lead sponsor
Delta University for Science and Technology
Responsible party
Omar Mohamed Ali Elabd (Lecturer of Orthopedics, Delta University for Science and Technology) — Principal investigator
First posted
Feb 9, 2023
Start date
Mar 3, 2020
Primary completion
Jun 15, 2022
Completion
Jan 7, 2023
Last update
Feb 9, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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