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Completed

NCT Number: NCT04224376

Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approac

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients awaiting primary ACL reconstruction surgery
  • Willingness to participate
  • Ability to work with an app based training device

Exclusion criteria

  • Additional meniscal suturing
  • Additional collateral ligament repair
  • Additional regenerative cartilage treatment
  • Unwillingness to participate in the study

Treatment and study plan

App based Serious Gaming with the Genu Sport knee trainer

Device

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.

Primary outcomes

  1. Absolute and relative change in maximum strength

    Time frame: 6 weeks

    Primarily, change in maximum strength was analyzed both, as an absolute difference between week 6 and pre-surgery value (6 weeks - pre-surgery) and as a relative change (6 weeks / pre-surgery).

Secondary outcomes

  1. Change in clinical outcome

    Time frame: 6 weeks

    IKDC, Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

  2. Change in clinical outcome

    Time frame: 6 weeks

    KOOS

  3. Change in clinical outcome

    Time frame: 6 weeks

    Tegner activity scale, scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer

  4. Change in clinical outcome

    Time frame: 6 weeks

    Lysholm, Maximum 100 points higher score means better Outcome

  5. Change in clinical outcome

    Time frame: 6 weeks

    VAS score, Values 0 to 10 higher values mean a worse outcome

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2020
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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