Other Clinical Trial - Improving Maximal Strength in the Initial

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Anterior Cruciate Ligament Rupture
Rupture

Clinical Trial Details

NCT number	NCT04224376
Study type	Interventional
Source	Hannover Medical School
Contact
Status	Completed
Phase	N/A
Start date	April 1, 2016
Completion date	October 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05487768` - Functional Connectivity After Anterior Cruciate Ligament Reconstruction	N/A
Recruiting	`NCT04390035` - BFRT in Adolescents After ACL Reconstruction	N/A
Recruiting	`NCT02740452` - Anterior Cruciate Ligament Rupture	N/A
Not yet recruiting	`NCT02555917` - Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction	N/A
Active, not recruiting	`NCT00529958` - Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction	N/A
Completed	`NCT05109871` - Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque	N/A
Not yet recruiting	`NCT06048874` - FNB in ACL Recon Under SA	N/A
Not yet recruiting	`NCT06048848` - FNB in ACL Recon Under GA	N/A
Terminated	`NCT03529552` - Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.	N/A
Completed	`NCT04285853` - Are Opioids Needed After ACL Reconstruction	Phase 4
Recruiting	`NCT04088227` - Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears	Phase 2
Active, not recruiting	`NCT03671421` - Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon	N/A
Not yet recruiting	`NCT04957706` - Diagnostic Study of ACL Rupture With Anterior Drawer Test at 90° of Hip Flexion
Not yet recruiting	`NCT04953676` - A Clinical Trial of the Round-tunnel and Flat-tunnel Technique of ACL Reconstruction	N/A
Enrolling by invitation	`NCT03365908` - Pain Management of ACL Reconstruction	N/A
Recruiting	`NCT06030791` - BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction
Recruiting	`NCT03950024` - Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma.	N/A
Recruiting	`NCT03229369` - Association of ALL and ACL Reconstruction Versus Isolated ACL Reconstruction in High-risk Population: a RCT.	N/A
Completed	`NCT01267435` - Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament	Phase 2
Recruiting	`NCT06430775` - Exploring Prolonged AMR in ACL Reconstructed Patients

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms