ACL TearNCT05241795
Knee vs. Ankle Training on Knee Mechanics After ACLR
A study testing Knee then Ankle rehabilitation protocol and Ankle then Knee rehabilitation protocol in people with ACL Tear and ACL Sprain, run by October 6 University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men only
- Conditions the study is for
- ACL Tear, ACL Sprain, Anterior Cruciate Ligament Rupture
- What is being tested?
- Knee then Ankle rehabilitation protocol and Ankle then Knee rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Feb 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- ACL reconstruction with a hamstring tendon autograft participated in this study.
- Score 7 on Tegner activity scale.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12511
Ahmed A Ashour, Ph.D, 01001973275 ext. 002, ahmed.ashour.pt@o6u.edu.eg
About this study
Official title: 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.
- Conditions
- ACL Tear, ACL Sprain, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
- Being tested
- Knee then Ankle rehabilitation protocol, Ankle then Knee rehabilitation protocol
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee then Ankle rehabilitation protocolOther
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
Ankle then Knee rehabilitation protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Knee exercises then Ankle exercises | Active comparator | Patients will receive a rehabilitation protocol starting with knee training followed by ankle training. Receives: Other: Knee then Ankle rehabilitation protocol |
| Group B: Ankle exercises then Knee exercises | Experimental | Patients will receive a rehabilitation protocol starting with ankle training followed by knee training. Receives: Other: Ankle then Knee rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 weeks posttreatment
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.
Measured: baseline and 6 weeks posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start13 Feb 2022
- Primary completion21 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Ali Hassan ElMeligie, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241795
- Sponsor's protocol ID
- ACL2122
- Status last verified
- Mar 2022
- First submitted
- 5 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Effect of Knee and Ankle Joint Training on Knee Mechanics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05241795
- Acronym / sponsor ID
- ACL2122
- Conditions
- ACL Tear, ACL Sprain, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 13 Feb 2022 (actual)
- Primary completion
- 21 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Knee exercises then Ankle exercises | Active comparator | Other: Knee then Ankle rehabilitation protocolPatients will receive a rehabilitation protocol starting with knee training followed by ankle training. |
| Group B: Ankle exercises then Knee exercises | Experimental | Other: Ankle then Knee rehabilitation protocolPatients will receive a rehabilitation protocol starting with ankle training followed by knee training. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ACL reconstruction with a hamstring tendon autograft participated in this study.
- Score 7 on Tegner activity scale.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee then Ankle rehabilitation protocolPatients 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 | Other | Group A: Knee exercises then Ankle exercises |
| Ankle then Knee rehabilitation protocolPatients 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. | Other | Group B: Ankle exercises then Knee exercises |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Yes. Participant data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee then Ankle rehabilitation protocol and Ankle then Knee rehabilitation protocol in people with ACL Tear and ACL Sprain, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Ashour, Ph.D (01001973275 ext. 002, ahmed.ashour.pt@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.