NCT05733936

Brief Summary

Purpose of the study is to investigate the effects of the criterion rehabilitation protocol versus accelerated rehabilitation protocol on the biomechanical determinants of the quality of performance and risk of reinjury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

January 28, 2023

Last Update Submit

January 20, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Dynamic knee valgus during Single leg landing-jump test using CLINICAL CLIMA 3DMA

    From the coronal plane, dynamic knee valgus is the angle of the knee

    15 minutes

  • Lateral trunk flexion during Single leg landing-jump test using CLINICAL CLIMA 3DMA

    From the coronal plane, trunk lateral flexion angle is the angle of the trunk

    15 minutes

  • knee flexion angle during Single leg landing-jump test using CLINICAL CLIMA 3DMA

    From sagittal plane, knee flexion angle is the angle of the knee

    15 minutes

Study Arms (2)

criterion-based rehabilitation protocol

EXPERIMENTAL

It's a three phases rehabilitation protocol with a goal-based progression which include a three criterion based postoperative phases: (1) impairment phase, (2) sport-specific training phase and (3) return to play phase. Patients can start with the next phase only if specific goals of the previous phase are achieved

Other: rehabilitation protocol

accelerated rehabilitation protocol

ACTIVE COMPARATOR

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

Interventions

rehabilitation protocols after ACLR have been described, aiming to improve muscle strength and knee stability through muscle strengthening exercises in addition to exercises to improve joint proprioception

accelerated rehabilitation protocolcriterion-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

Knee Injuries

Condition Hierarchy (Ancestors)

Leg 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 17, 2023

Study Start

February 20, 2023

Primary Completion

February 1, 2024

Study Completion

December 1, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations