- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05241795
Knee vs. Ankle Training on Knee Mechanics After ACLR
March 16, 2022 updated by: Mohamed Magdy Ali Hassan ElMeligie, October 6 University
Crossover Effect of Knee and Ankle Joint Training on Knee Mechanics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
This study will be conducted to investigate if there is any difference between starting rehabilitation program after ACL reconstruction with knee joint training followed by ankle joint training and starting it with ankle joint training followed by knee joint training (crossover effect) on gait parameters of the knee joint.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
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 Contact
- Name: Ahmed A Ashour, Ph.D
- Phone Number: 002 01001973275
- Email: ahmed.ashour.pt@o6u.edu.eg
Study Locations
-
-
Giza
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Al Ḩayy Ath Thāmin, Giza, Egypt, 12511
- Recruiting
- October 6 university hospital
-
Contact:
- Ahmed A Ashour, Ph.D
- Phone Number: 002 01001973275
- Email: ahmed.ashour.pt@o6u.edu.eg
-
-
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
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- ACL reconstruction with a hamstring tendon autograft participated in this study.
- Score 7 on Tegner activity scale.
Exclusion Criteria:
- Patients with bilateral knee injury
- History of surgery or traumatic injury to the uninvolved lower extremity or to the hip or ankle of the involved lower extremity
- History of ACL reconstruction on the ipsilateral side and other knee ligament injuries requiring surgery.
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group A: Knee exercises then Ankle exercises
Patients will receive a rehabilitation protocol starting with knee training followed by ankle training.
|
Patients will start with knee exercise program that includes
Then, Patients will start ankle exercises program that includes:
|
EXPERIMENTAL: Group B: Ankle exercises then Knee exercises
Patients will receive a rehabilitation protocol starting with ankle training followed by knee training.
|
Patients will start ankle exercises program that includes:
Then, Patients will start with knee exercise program that includes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Knee joint flexion torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
Time Frame: baseline and 6 weeks posttreatment
|
Knee joint flexion torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.
|
baseline and 6 weeks posttreatment
|
Change in Knee joint extension torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
Time Frame: baseline and 6 weeks posttreatment
|
Knee joint extension torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.
|
baseline and 6 weeks posttreatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 13, 2022
Primary Completion (ANTICIPATED)
July 21, 2022
Study Completion (ANTICIPATED)
August 1, 2022
Study Registration Dates
First Submitted
February 5, 2022
First Submitted That Met QC Criteria
February 5, 2022
First Posted (ACTUAL)
February 16, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2022
Last Update Submitted That Met QC Criteria
March 16, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACL2122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Participant data will be shared
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
personal email: mohamed.magdy.pt@o6u.edu.eg
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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