Determining the Effects of Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After ACL Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorArcadia University

About this trial

After knee surgery for a torn ACL, many women struggle with weak thigh muscles for years, partly due to reduced brain signals to these muscles. Our research tests a new approach to improve recovery by using low-level brain stimulation to boost these signals. The investigators will study 42 women, aged 18-35, who had ACL surgery. They'll be split into two groups: one receiving real brain stimulation and another getting a placebo, both during thigh-strengthening exercises. Over six sessions, the investigators measure thigh muscle strength, speed, and steadiness, plus two brain signal measures, using special equipment. The investigators will also check if stronger brain signals lead to better muscle performance, especially in women. Our goal is to show that this new method strengthens thigh muscles better than standard rehab, helping women recover better after surgery. If successful, this could improve physical therapy for women recovering from ACL surgery, making daily activities and return to sport easier.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

multiple ligament reconstruction

osteochondral procedures

any previous lower extremity surgery

previous ACL injury

Trial design

Design model

Parallel

Treatments tested in this trial

  • active transcranial direct current stimulation (tDCS)

    Device

    20 minutes of anodal tDCS over the primary motor cortex contralateral to the participants surgical limb during a quadriceps torque matching task

  • sham transcranial direct current stimulation (tDCS)

    Device

    Participants receive sham tDCS in which the device only delivers current during the first and last 30 seconds while participants perform a quadriceps torque matching task

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Active tDCSActive comparator 1 intervention
Group B: Sham tDCSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak quadriceps muscle torque

Peak torque during a 5 second maximal voluntary isometric contraction

Time frame
Pre and post intervention
2

Corticospinal excitability (Slope)

Slope of a TMS induced stimulus-response curve

Time frame
Pre and post intervention

Secondary outcomes

1

Rate of Torque Development (RTD)

RTD of a maximal voluntary isometric contraction from onset to 100ms (RTD100) and from 100 to 200ms (RTD200) will be used.

Time frame
Pre and post intervention
2

Corticospinal excitability (Active Motor Threshold)

The lowest stimulator intensity needed to produce consistent MEPs \>/= 100 microvolts while the participant maintains an isometric contraction at 5% of their MVIC

Time frame
Pre and post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arcadia University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator