NCT06863610

Brief Summary

Knee extension loss following an anterior cruciate ligament (ACL) reconstruction is believed to play an important role in quadriceps strength recovery. One of the main goals of the rehabilitation following ACL reconstruction is to restore knee extensor muscle strength. Deficits of more than a five-degree extension range of motion (ROM) could lead to delayed knee functionality and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known. This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (\>5°) in the early postoperative period and those who did not.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2025Jul 2026

First Submitted

Initial submission to the registry

February 22, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

February 22, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

ACLreconstructionkneeextension deficit

Outcome Measures

Primary Outcomes (2)

  • Quadriceps Muscle Strength Recovery

    Isometric, concentric and eccentric quadriceps muscle strength will be measured using an isokinetic dynamometer (IsoMed®2000 D\&R GmbH, Germany).

    Qudriceps muscle strength will be measured at 4th weeks (isometric), 12 th weeks (isometric and concentric), 6th months (isometric, concentric, and eccentric) following a surgery.

  • Hamstring Muscle Strength Recovery

    Isometric, concentric and eccentric hamstring muscle strength will be measured using an isokinetic dynamometer (IsoMed®2000 D\&R GmbH, Germany).

    Hamstring muscle strength will be measured at 4th weeks (isometric), 12 th weeks (isometric and concentric), 6th months (isometric, concentric, and eccentric) following a surgery.

Secondary Outcomes (5)

  • The Y Balance Test. Functional Testing 1

    Assessments will be conducted at 12th weeks and 6th months following a surgery

  • The Vertical Jump Test. Functional Testing 2

    Assessments will be conducted at 12th weeks and 6th months following a surgery

  • The Single Leg Hop Test. Functional Testing 3

    Assessments will be conducted at 12th weeks and 6th months following a surgery

  • The Lysholm score. Patient-reported outcomes measures 1

    Self-reported recovery will be recorded at 12th weeks and 6th months following a surgery

  • The International Knee Documentation Committee subjective knee form (IKDC). Patient-reported outcomes measures 2

    Self-reported recovery will be recorded at 12th weeks and 6th months following a surgery

Study Arms (2)

Extension Deficit (>5 degrees)

EXPERIMENTAL

Patients who had a knee extension ROM deficit of more than 5 degrees in the fourth week will be subject to the rehabilitation program under the supervision of the same physiotherapist 3 days a week for a period of 12 weeks. The rehabilitation program will include cold therapy, electrotherapy, and exercises focusing on improving knee functioning and restoring muscle strength. From 12 weeks to 6 months, a home exercise program will be advised to all patients equally.

Other: Extension Deficit (>5 degrees)

Extension Deficit (<5 degrees)

ACTIVE COMPARATOR

Patients who had a knee extension ROM deficit of less than 5 degrees in the fourth week will be subject to the rehabilitation program under the supervision of the same physiotherapist 3 days a week for a period of 12 weeks. The rehabilitation program will include cold therapy, electrotherapy, and exercises focusing on improving knee functioning and restoring muscle strength. From 12 weeks to 6 months, a home exercise program will be advised to all patients equally.

Other: Extension Deficit (<5 degrees)

Interventions

Patients who had a knee extension ROM deficit of less than 5 degrees will included

Extension Deficit (<5 degrees)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who underwent ACL repair using hamstring tendon autograft
  • volunteered to participate in the study between the ages of 18-45
  • a non-contact injury mechanism
  • a Tegner Activity Score \>5 before the injury
  • regularly attended the rehabilitation program after surgery (not missing more than three sessions)

You may not qualify if:

  • Patients who underwent ACL repair with patellar tendon autograft or allograft, revision surgery
  • underwent meniscus and or cartilage repair in addition to ACL repair
  • a history of previous knee, ankle, or groin injuries
  • concomitant systemic and/or neurological pathologies
  • a history of injury to the contralateral lower extremity
  • do not want to participate in the evaluations that should be done before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Leyla Eraslan, Ph. D.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyla Eraslan, Ph. D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 22, 2025

First Posted

March 7, 2025

Study Start

March 15, 2025

Primary Completion

March 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations