- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304561
The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction
January 31, 2018 updated by: GULCAN HARPUT, Hacettepe University
Contralateral Strength Training Effects on Functional Outcomes in Patients Who Had Undergone ACL Reconstruction: Randomized Controlled Trial
Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles.
With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Returning to sport after ACL reconstruction is not at desired level among athletes.
Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction.
Cross-over training is recomended during rehabilitation after ACL reconstrucion.
Yet duration of the training, frequancy and type of exercise interention are not clear for the cross-over training.
Ain of the study is to investigate the effects of cross-over training on muscle strenght
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
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
-
-
-
Ankara, Turkey, 06100
- Sports Physiotherapy Unit
-
-
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 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- having surgery of ACL reconstruction on one side
- having no problem at least six month on the nonsrgical side
- recieving the rehabilitation programme at hacettepe university, physiotherapy department
Exclusion Criteria:
- refusing to include to the study
- having revision ACL surgery
- addition of PCL or cartilage surgery addition to the ACL surgery
- not participating to the rehabilidation program regularly over 3 month after sugery
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: traditional rehabilitation
patients in this groups is going to recieve traditional rehabilitation programme for 3 months after ACL recontsruction
|
traditional ACL rehabilitation program
Other Names:
|
Experimental: Cross-over training
patients in this programme is going to recieve isokinetic exercise programme targeting unilvolved limb during rehabilitation.
for the first 4 weeks after ACL reconstruction traditional rehabiitation programme is going to applied to the subjects.
after 4 weeks, isokinetic strenghtening programme at 60˚/second angular velocity, between 0-90 degree knee flexion until 3 months after ACL reconstructon
|
Cross-over training addition to the traditional rehabilidation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quadriceps and hamstring muscle strenght
Time Frame: 6 month
|
quadriceps strength change during the first, second and sixth months of the rehabilitation proccess after ACL reconstruction surgery.
the strength measurements will conducted on isokinetic dynamometer (isomed 2000)
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional outcomes
Time Frame: 6 month
|
one leg hop test, vertical jump test on the sixth month after surgery.
the functional outcomes will be measured only at the sixth month after surgery.
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: volga tunay, PhD, volgamel@yahoo.com
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 (Actual)
October 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
October 30, 2017
Study Registration Dates
First Submitted
October 4, 2017
First Submitted That Met QC Criteria
October 4, 2017
First Posted (Actual)
October 9, 2017
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
January 31, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 123456 (UMMashhad)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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