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

January 13, 2020 updated by: Clausen, Jan-Dierk Dr., Hannover Medical School
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 48 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional rehabilitation
Normal postoperative treatment protocol with physiotherapy after ACL surgery
Experimental: Serious Gaming
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.
Device: App based Serious Gaming with the Genu Sport knee trainer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weeks
Change in clinical outcome
Time Frame: 6 weeks
KOOS
6 weeks
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
6 weeks
Change in clinical outcome
Time Frame: 6 weeks
Lysholm, Maximum 100 points higher score means better Outcome
6 weeks
Change in clinical outcome
Time Frame: 6 weeks
VAS score, Values 0 to 10 higher values mean a worse outcome
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Thomas Sanjay Weber-Spickschen, MD, Trauma Departement, Hanover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3102-2016 VKB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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