NCT07156734

Brief Summary

A major complication after cruciate ligament injury and surgery is arthrogenic muscle inhibition of the quadriceps, which is characterised by a deficit in voluntary muscle activation in the affected leg. This can hinder rehabilitation processes, lead to impaired knee function, and negatively impact the patients' quality of life. The primary objective of this study is to assess whether voluntary quadriceps activation on the injured side is facilitated by the concomitant application of neuromuscular electrical stimulation (NMES) on the contralateral quadriceps.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2025

Status
not yet 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 Progress68%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

August 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 27, 2025

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • EMG activity

    EMG data will be recorded from the vastus medialis, vastus lateralis and rectus femoris muscles.

    Data will be collected at two time points: after ACL injury (within two weeks prior to surgery) and following ACL reconstruction (within three days post-surgery).

Study Arms (1)

Contralateral NMES

EXPERIMENTAL

Participants receive neuromuscular electrical stimulation (NMES) applied to the quadriceps muscle of the contralateral leg while performing voluntary quadriceps contractions on the injured side. Each participant completes two sessions: one after ACL injury and one after ACL reconstruction surgery.

Device: Neuromuscular Electrical Stimulation

Interventions

Studies in healthy individuals have demonstrated that NMES applied to the quadriceps of one limb induces short-term increases in strength and neural drive in the contralateral homologous muscle. Since these effects have only been observed in healthy individuals, it is essential to investigate whether similar responses occur in ACL patients.

Contralateral NMES

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing ACL surgery with semitendinosus tendon autograft in the Schulthess Clinic
  • Unilateral and primary ACL injury (with/without diagnoses of additional meniscus injury)

You may not qualify if:

  • Previous surgery/ligament rupture in injured or uninjured knee or hip
  • Severe pain in the uninjured-side quadriceps or knee joint
  • Ongoing pregnancy
  • BMI \>30 kg/m²
  • Neuromuscular disease
  • Open wounds or tissue injuries on the anterior aspect of the thigh
  • Additional rupture of other knee ligaments (posterior cruciate ligament, medial collateral ligament, lateral collateral ligament)
  • Implanted metallic/electronic devices (cardiac pacemakers, defibrillators)
  • Patients getting a femoralis block (peripheral nerve block) after surgery will be excluded for the post-surgical appointment
  • Insufficient language comprehension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Nicola Angelo Maffiuletti, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Research Group Human Performance Lab

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 5, 2025

Study Start

September 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 5, 2025

Record last verified: 2025-08