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

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
App based Serious Gaming with the Genu Sport knee trainer
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring ACL rupture, return to sports

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Conventional rehabilitation

    Serious Gaming

    Arm Description

    Normal postoperative treatment protocol with physiotherapy after ACL surgery

    In the training group each patient 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. Other postoperative treatment was identical.

    Outcomes

    Primary Outcome Measures

    Absolute and relative change in maximum strength
    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 Outcome Measures

    Change in clinical outcome
    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)
    Change in clinical outcome
    KOOS
    Change in clinical outcome
    Tegner activity scale, scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer
    Change in clinical outcome
    Lysholm, Maximum 100 points higher score means better Outcome
    Change in clinical outcome
    VAS score, Values 0 to 10 higher values mean a worse outcome

    Full Information

    First Posted
    January 7, 2020
    Last Updated
    January 13, 2020
    Sponsor
    Hannover Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04224376
    Brief Title
    Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approac
    Official Title
    Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approac
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    February 1, 2018 (Actual)
    Study Completion Date
    October 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hannover Medical School

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Rupture
    Keywords
    ACL rupture, return to sports

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional rehabilitation
    Arm Type
    No Intervention
    Arm Description
    Normal postoperative treatment protocol with physiotherapy after ACL surgery
    Arm Title
    Serious Gaming
    Arm Type
    Experimental
    Arm Description
    In the training group each patient 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. Other postoperative treatment was identical.
    Intervention Type
    Device
    Intervention Name(s)
    App based Serious Gaming with the Genu Sport knee trainer
    Intervention Description
    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 Outcome Measure Information:
    Title
    Absolute and relative change in maximum strength
    Description
    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).
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in clinical outcome
    Description
    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)
    Time Frame
    6 weeks
    Title
    Change in clinical outcome
    Description
    KOOS
    Time Frame
    6 weeks
    Title
    Change in clinical outcome
    Description
    Tegner activity scale, scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer
    Time Frame
    6 weeks
    Title
    Change in clinical outcome
    Description
    Lysholm, Maximum 100 points higher score means better Outcome
    Time Frame
    6 weeks
    Title
    Change in clinical outcome
    Description
    VAS score, Values 0 to 10 higher values mean a worse outcome
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Sanjay Weber-Spickschen, MD
    Organizational Affiliation
    Trauma Departement, Hanover Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20660401
    Citation
    Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797. Erratum In: N Engl J Med. 2010 Aug 26;363(9):893.
    Results Reference
    background
    PubMed Identifier
    28097305
    Citation
    Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
    Results Reference
    background
    PubMed Identifier
    23675790
    Citation
    Sims J, Cosby N, Saliba EN, Hertel J, Saliba SA. Exergaming and static postural control in individuals with a history of lower limb injury. J Athl Train. 2013 May-Jun;48(3):314-25. doi: 10.4085/1062-6050-48.2.04. Epub 2013 Feb 20.
    Results Reference
    background
    PubMed Identifier
    29465298
    Citation
    Horstmann H, Krost E, Welke B, Kerling A, Hanke A, Jakubowitz E, Weber-Spickschen TS. The determination of the validity of an application-based knee-training device. Assist Technol. 2019;31(5):259-266. doi: 10.1080/10400435.2018.1441924. Epub 2018 Apr 10.
    Results Reference
    background

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

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