Knee vs. Ankle Training on Knee Mechanics After ACLR

Sponsor

October 6 University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05241795

Collaborator

(none)

Enrollment

Location

Arms

5.6

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ACL Tear ACL Sprain Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries	Other: Knee then Ankle rehabilitation protocol Other: Ankle then Knee rehabilitation protocol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Crossover Effect of Knee and Ankle Joint Training on Knee Mechanics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Actual Study Start Date :

Feb 13, 2022

Anticipated Primary Completion Date :

Jul 21, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.	Other: Knee then Ankle rehabilitation protocol 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
Experimental: Group B: Ankle exercises then Knee exercises Patients will receive a rehabilitation protocol starting with ankle training followed by knee training.	Other: Ankle then Knee rehabilitation protocol 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.

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.

Other: Knee then Ankle rehabilitation protocol

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

Experimental: Group B: Ankle exercises then Knee exercises

Patients will receive a rehabilitation protocol starting with ankle training followed by knee training.

Other: Ankle then Knee rehabilitation protocol

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.

Outcome Measures

Primary Outcome Measures

Change in Knee joint flexion torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 University Hospital	Al Ḩayy Ath Thāmin	Giza	Egypt	12511

Sponsors and Collaborators

October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Magdy Ali Hassan ElMeligie, Principal investigator, October 6 University

ClinicalTrials.gov Identifier:

NCT05241795

Other Study ID Numbers:

ACL2122

First Posted:

Feb 16, 2022

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rupture

Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Mar 18, 2022