NCT06913543

Brief Summary

"Anterior cruciate ligament (ACL) reconstruction is a commonly performed surgical procedure for restoring knee stability in patients following ACL injuries. Despite surgical success, postoperative rehabilitation remains crucial for improving functional outcomes, addressing quadriceps strength deficits, and reducing recovery time.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (2)

  • Lysholm Knee Scoring Scale

    Measures knee function with a maximum score of 100. Scoring Interpretation: 95-100 points: Excellent function. 84-94 points: Good function. 65-83 points: Fair function. \<65 points: Poor function.

    12 Months

  • Universal Goniometer

    Measures ROM (Flexion \& Extension). Interpretation: Knee flexion and extension are assessed against standard angles. Higher reliability and validity in measuring knee movement.

    12 Months

Study Arms (2)

Group 1 (Experimental Group - OKC + NMES)

EXPERIMENTAL
Combination Product: Group 1 (Experimental Group - OKC + NMES)

Group 2 (Control Group - OKC Only

ACTIVE COMPARATOR
Diagnostic Test: Group 2 (Control Group - OKC Only

Interventions

Group 1 (Experimental Group - OKC + NMES)COMBINATION_PRODUCT

OKC Knee Extension Exercises: Seated Knee Extensions: Resistance bands or machine, 10-15 reps, 2-3 sets. Straight Leg Raises: With or without ankle weights, 12-15 reps, 2-3 sets. Quadriceps Isometric Holds: Held for 5-10 seconds, 10 reps, 2-3 sets. Neuromuscular Electrical Stimulation (NMES): Electrode Placement: Over the motor points of the quadriceps. Frequency: 35-50 Hz. Pulse Duration: 200 microseconds. Intensity: Adjusted for strong yet tolerable contractions. On-Off Cycle: 10 seconds on, 20 seconds off.

Group 1 (Experimental Group - OKC + NMES)
Group 2 (Control Group - OKC OnlyDIAGNOSTIC_TEST

Open Kinetic Chain Knee Extension Exercises without NMES. Method \& Details: The same OKC exercises as the experimental group but without NMES. All exercises are supervised by trained physiotherapists.

Group 2 (Control Group - OKC Only

Eligibility Criteria

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

You may qualify if:

  • Both genders aged 18-45 years
  • Subjects who have undergone unilateral primary ACL reconstruction surgery
  • Subjects who are exactly 4 weeks post-surgery at the start of the study
  • Subjects who received a hamstring tendon autograft or patellar tendon graft for ACL reconstruction
  • Subjects cleared by a physician to begin open kinetic chain exercises in their rehabilitation program
  • Subjects who are generally healthy with no significant comorbidities that could interfere with rehabilitation
  • Willingness to provide informed consent and commit to the entire duration of the study

You may not qualify if:

  • Presence of additional knee injuries (e.g., meniscal tears, collateral ligament injuries) that might affect rehabilitation
  • History of prior ACL injury or reconstruction on the same knee
  • Patients who underwent reconstruction of other ligaments along with the ACL
  • Presence of conditions (e.g., rheumatoid arthritis, osteoarthritis, uncontrolled diabetes) that could influence recovery
  • Any significant injury or surgery to the opposite knee within the last six months
  • Factors that indicate a high risk of non-compliance with the rehabilitation protocol, such as poor availability, or lack of commitment to follow the exercise regimen
  • Conditions affecting neuromuscular control that could interfere with exercise performance or rehabilitation response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MOVEBETTER 14-A Koh-e-Noor Road, Basement Salt N Pepper

Faisalābad, Punjab Province, Pakistan

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
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)