NCT04224376

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

January 7, 2020

Last Update Submit

January 13, 2020

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACL rupturereturn to sports

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 weeks

Secondary Outcomes (5)

  • Change in clinical outcome

    6 weeks

  • Change in clinical outcome

    6 weeks

  • Change in clinical outcome

    6 weeks

  • Change in clinical outcome

    6 weeks

  • Change in clinical outcome

    6 weeks

Study Arms (2)

Conventional rehabilitation

NO INTERVENTION

Normal postoperative treatment protocol with physiotherapy after ACL surgery

Serious Gaming

EXPERIMENTAL

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

Interventions

App based Serious Gaming with the Genu Sport knee trainerDEVICE

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.

Serious Gaming

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 20660401BACKGROUND

  • 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.

    PMID: 28097305BACKGROUND

  • 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.

    PMID: 23675790BACKGROUND

  • 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.

    PMID: 29465298BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Thomas Sanjay Weber-Spickschen, MD

    Trauma Departement, Hanover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 13, 2020

Study Start

April 1, 2016

Primary Completion

February 1, 2018

Study Completion

October 1, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share