Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction

Phase 2

• Conditions: Complete Tear, Knee, Anterior Cruciate Ligament

• Registration Number: NCT02930239
• Lead Sponsor: Linkoeping University

Brief Summary

A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be added to the existing care received at Linkoping University Hospital 2 weeks post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a clinical examination.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-08
• Study Start: 2016-03
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-11
• Last Update Submitted: 2016-10-11
• Study First Posted: 2016-10-12
• Last Update Posted: 2016-10-12
• Primary Completion: 2017-07
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Anterior cruciate ligament injury occurred a minimum of 3 weeks prior to surgery

Exclusion Criteria

• Previous Anterior cruciate ligament injury
• Other knee injury with restrictions that could interfere with rehabilitation
• Other injury or disease that could interfere with rehabilitation
• Inability to understand the information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
3 dimensional gait analysis	5 weeks post-surgery	A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score	5 weeks post-surgery	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire which consists of 42 items which can be sub grouped into five categories. These categories are pain, other disease-specific symptoms, activities of daily living (ADL), sport and recreation function and lastly knee-related quality of life.
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)	12 weeks post-surgery	The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function.
3 dimensional gait analysis	12 weeks post-surgery	A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg

Trial Locations

Locations (1)

Linkoping University; 🇸🇪 Linkoping, Ostergotland, Sweden