Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction

October 11, 2016 updated by: Joanna Kvist, Linkoeping University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Ostergotland
      • Linkoping, Ostergotland, Sweden, 58183
        • Recruiting
        • Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait rehabilitation
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.
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.
Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital
Exercises for increased movement and circulation performed on a daily basis.
Active Comparator: Control group
Will only receive the standardized rehabilitation at Linkoping University Hospital.
Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital
Exercises for increased movement and circulation performed on a daily basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 dimensional gait analysis
Time Frame: 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
5 weeks post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score
Time Frame: 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.
5 weeks post-surgery
International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
Time Frame: 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.
12 weeks post-surgery
3 dimensional gait analysis
Time Frame: 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
12 weeks post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Joanna Kvist, Professor, Linköping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • dnr 2016/25-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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