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
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring ACL rupture, return to sports
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
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
NCT ID
NCT04224376
First Posted
January 7, 2020
Last Updated
January 13, 2020
Sponsor
Hannover Medical School
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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