Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approac
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The investigators designed a prospective randomized trial to evaluate whether an app based
      active muscle training program (GenuSport) can improve the postoperative strength by starting
      rehabilitation immediately after primary anterior cruciate ligament (ACL) reconstruction
      surgery as already shown for patients who underwent total knee arthroplasty. To the
      investigators knowledge this is the first study analyzing immediate postoperative serious
      gaming based training with the GenuSport device based on strength improvement.
    

Detailed description: 
      The study is designed as a prospective randomized control trial. Participants awaiting
      primary ACL reconstruction surgery were recruited at a single tertiary healthcare center
      between April 2016 and February 2018. An ethical approval has been given by MHH ethic
      committee and an IRB was involved. Due to different postoperative treatment protocols and
      different surgical approaches we could include participants between 13 and 46 years. A
      computer based randomization was performed by generating a list of randomized numbers which
      have been provided in sealed envelopes by an independent examiner. The postoperative
      treatment protocol was apart from the use of the GenuSport knee trainer identically
      standardized. The pain management was the same for all patients, none of the participants
      received a continuous peripheral nerve block. The postoperative physiotherapy protocol
      included gait training, assisted walking with crutches, active and passive knee mobilization,
      strength exercises and stair climbing. In the training group each participant was
      additionally provided with a GenuSport knee trainer device (prototype plus tablet with
      software application) with the active knee extension training program for 6 weeks. Except of
      that fact the postoperative protocol was identical in both groups. Participant had to train
      five times daily with the knee trainer starting at the day of surgery.
    

Intervention name(s): App based Serious Gaming with the Genu Sport knee trainer
Intervention type(s): Device
Intervention description(s): The Genu Sport knee trainer has a strength monitoring unit with three integrated sensors which is placed in the popliteal area and a tablet with the application which allows to transfer the raised force into the game modus. Each training session in our study takes around 5 minutes and is performed autonomously by the patient in his bed with 45° degrees of upper body evaluation while the patient holds the tablet in both hands. By simply pushing his knee downward onto the measuring unit the patient can apply the force.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ACL rupture; return to sports