Knee vs. Ankle Training on Knee Mechanics After ACLR
Primary Purpose
ACL Tear, ACL Sprain, Anterior Cruciate Ligament Rupture
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Knee then Ankle rehabilitation protocol
Ankle then Knee rehabilitation protocol
Sponsored by
About this trial
This is an interventional treatment trial for ACL Tear
Eligibility Criteria
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.
Sites / Locations
- October 6 University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A: Knee exercises then Ankle exercises
Group B: Ankle exercises then Knee exercises
Arm Description
Patients will receive a rehabilitation protocol starting with knee training followed by ankle training.
Patients will receive a rehabilitation protocol starting with ankle training followed by knee training.
Outcomes
Primary Outcome Measures
Change in Knee joint flexion torques (Nm/kg) in the supporting (stance) phase at 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.
Change in Knee joint extension torques (Nm/kg) in the supporting (stance) phase at 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05241795
Brief Title
Knee vs. Ankle Training on Knee Mechanics After ACLR
Official Title
Crossover Effect of Knee and Ankle Joint Training on Knee Mechanics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2022 (Actual)
Primary Completion Date
July 21, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Tear, ACL Sprain, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Knee exercises then Ankle exercises
Arm Type
Active Comparator
Arm Description
Patients will receive a rehabilitation protocol starting with knee training followed by ankle training.
Arm Title
Group B: Ankle exercises then Knee exercises
Arm Type
Experimental
Arm Description
Patients will receive a rehabilitation protocol starting with ankle training followed by knee training.
Intervention Type
Other
Intervention Name(s)
Knee then Ankle rehabilitation protocol
Intervention Description
Patients will start with knee exercise program that includes
Partial Squats: The exercise will be performed as 3 sets of 10 repetitions each day.
Toe Raises: The exercise will be performed as 3 sets of 10 repetitions each day.
Stationary bike will be used (10-15 minutes /day) when the patients can bend their knees at least 100 degrees, as cycling is considered as an excellent conditioning and building exercise for the quadriceps muscles. As the patient's ability to pedal the bike with the operative leg improved, the therapist will increase the resistance.
Hamstring exercises: After 6 weeks, the hamstring muscles will be exercised by the patient pulling the heel back producing a hamstring contraction.
Then, Patients will start ankle exercises program that includes:
Standing calf raises
Foot lift
Ankle eversion exercises
Ankle Plantarflexion exercises
Intervention Type
Other
Intervention Name(s)
Ankle then Knee rehabilitation protocol
Intervention Description
Patients will start ankle exercises program that includes:
Standing calf raises
Foot lift
Ankle eversion exercises
Ankle Plantarflexion exercises
Then, Patients will start with knee exercise program that includes
Partial Squats: The exercise will be performed as 3 sets of 10 repetitions each day.
Toe Raises: The exercise will be performed as 3 sets of 10 repetitions each day.
Stationary bike will be used (10-15 minutes /day) when the patients can bend their knees at least 100 degrees, as cycling is considered as an excellent conditioning and building exercise for the quadriceps muscles. As the patient's ability to pedal the bike with the operative leg improved, the therapist will increase the resistance.
Hamstring exercises: After 6 weeks, the hamstring muscles will be exercised by the patient pulling the heel back producing a hamstring contraction.
Primary Outcome Measure Information:
Title
Change in Knee joint flexion torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
Description
Knee joint flexion torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.
Time Frame
baseline and 6 weeks posttreatment
Title
Change in Knee joint extension torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
Description
Knee joint extension torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.
Time Frame
baseline and 6 weeks posttreatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Ashour, Ph.D
Phone
01001973275
Ext
002
Email
ahmed.ashour.pt@o6u.edu.eg
Facility Information:
Facility Name
October 6 University Hospital
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
12511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Ashour, Ph.D
Phone
01001973275
Ext
002
Email
ahmed.ashour.pt@o6u.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Knee vs. Ankle Training on Knee Mechanics After ACLR
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