NCT05719974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

2.3 years

First QC Date

January 28, 2023

Last Update Submit

February 8, 2023

Conditions

Knee Ligament InjuryAnterior Cruciate Ligament Injuries

Outcome Measures

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

    6 months

Secondary Outcomes (3)

  • limb symmetry index of hop test battery

    6 months

  • Knee Injury and Osteoarthritis Outcome Score

    6 months

  • knee effusion grading scale

    6 months

Study Arms (2)

criterion-based rehabilitation protocol

EXPERIMENTAL
Other: rehabilitation protocol

conventional physical therapy program

ACTIVE COMPARATOR
Other: rehabilitation protocol

Interventions

rehabilitation protocolOTHER

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.

conventional physical therapy programcriterion-based rehabilitation protocol

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta university

Gamasa, Eldakahlyia, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthopedics

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 9, 2023

Study Start

March 3, 2020

Primary Completion

June 15, 2022

Study Completion

January 7, 2023

Last Updated

February 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)