Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction

Phase 2

• Conditions: Complete Tear, Knee, Anterior Cruciate Ligament
• Interventions: Other: Gait rehabilitating with reduced bodyweight; Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital

• 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

Arm && Interventions

Group	Intervention	Description
Gait rehabilitation	Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital	Will perform 2 weeks of gait rehabilitation using the anti gravity treadmill. Intervention will start 2 weeks post-surgery. This rehabilitation will be performed simultaneously as the patient receives the standardized rehabilitation at Linkoping University Hospital.
Control group	Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital	Will only receive the standardized rehabilitation at Linkoping University Hospital.
Gait rehabilitation	Gait rehabilitating with reduced bodyweight	Will perform 2 weeks of gait rehabilitation using the anti gravity treadmill. Intervention will start 2 weeks post-surgery. This rehabilitation will be performed simultaneously as the patient receives the standardized rehabilitation at Linkoping University Hospital.

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