Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction

Complete Tear, Knee, Anterior Cruciate Ligament Clinical Trial

Official title:

Early Initiated Gait Rehabilitation Using the Anti-gravity Treadmill Following an Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02930239
• Other study ID #: dnr 2016/25-31
• Status: Recruiting
• Phase: Phase 2
• First received: February 8, 2016
• Last updated: October 11, 2016
• Start date: March 2016
• Est. completion date: February 2018

Study information

• Verified date: October 2016
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Tear, Knee, Anterior Cruciate Ligament

Intervention

Other:
• Gait rehabilitating with reduced bodyweight
Patients will perform 8 sessions of gait rehabilitation with reduced bodyweight using the anti gravity treadmill during week 2-5 post-surgery.
• Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital
Exercises for increased movement and circulation performed on a daily basis.

Locations

Country	Name	City	State
Sweden	Linkoping University	Linkoping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 dimensional gait analysis	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	5 weeks post-surgery	No
Secondary	Knee Injury and Osteoarthritis Outcome Score	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.	5 weeks post-surgery	No
Secondary	International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)	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.	12 weeks post-surgery	No
Secondary	3 dimensional gait analysis	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	12 weeks post-surgery	No