Knee InjuriesNCT05733936
Biomechanical Determinants of Different Rehabilitation Protocols for ACL Reconstruction
A study testing rehabilitation protocol in people with Knee Injuries and Rehabilitation, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Purpose of the study is to investigate the effects of the criterion rehabilitation protocol versus accelerated rehabilitation protocol on the biomechanical determinants of the quality of performance and risk of reinjury. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries, Rehabilitation
- What is being tested?
- rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to Dec 2024
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft.
- Ranging in age from 18 to 35 years.
- Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility
- Ability to actively control the quadriceps.
Who cannot join
- ACLR with any graft other than a hamstring graft
- ACL revision surgery
- associated medial or lateral ligamentous injuries
- previous meniscectomy or meniscal repair
- simultaneous meniscectomy or meniscus repair with the ACLR
- cartilage damage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Biomechanical Determinants of Rehabilitation Protocols for ACL Reconstruction on the Quality of Performance and Risk of Reinjury: Randomized Controlled Trial
Purpose of the study is to investigate the effects of the criterion rehabilitation protocol versus accelerated rehabilitation protocol on the biomechanical determinants of the quality of performance and risk of reinjury.
- Conditions
- Knee Injuries, Rehabilitation
- Being tested
- rehabilitation protocol
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation protocolOther
rehabilitation protocols after ACLR have been described, aiming to improve muscle strength and knee stability through muscle strengthening exercises in addition to exercises to improve joint proprioception
| Study group | Role | What they receive |
|---|---|---|
| criterion-based rehabilitation protocol | Experimental | It's a three phases rehabilitation protocol with a goal-based progression which include a three criterion based postoperative phases: (1) impairment phase, (2) sport-specific training phase and (3) return to play phase. Patients can start with the next phase only if specific goals of the previous phase are achieved Receives: Other: rehabilitation protocol |
| accelerated rehabilitation protocol | Active comparator | It's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises Receives: Other: rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic knee valgus during Single leg landing-jump test using CLINICAL CLIMA 3DMA
From the coronal plane, dynamic knee valgus is the angle of the knee
Measured: 15 minutes
Lateral trunk flexion during Single leg landing-jump test using CLINICAL CLIMA 3DMA
From the coronal plane, trunk lateral flexion angle is the angle of the trunk
Measured: 15 minutes
knee flexion angle during Single leg landing-jump test using CLINICAL CLIMA 3DMA
From sagittal plane, knee flexion angle is the angle of the knee
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start20 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Ali Elabd, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733936
- Sponsor's protocol ID
- 004270
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Biomechanical Determinants of Rehabilitation Protocols for ACL Reconstruction on the Quality of Performance and Risk of Reinjury: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05733936
- Acronym / sponsor ID
- 004270
- Conditions
- Knee Injuries, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Feb 2023 (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.
Purpose of the study is to investigate the effects of the criterion rehabilitation protocol versus accelerated rehabilitation protocol on the biomechanical determinants of the quality of performance and risk of reinjury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| criterion-based rehabilitation protocol | Experimental | Other: rehabilitation protocolIt's a three phases rehabilitation protocol with a goal-based progression which include a three criterion based postoperative phases: (1) impairment phase, (2) sport-specific training phase and (3) return to play phase. Patients can start with the next phase only if specific goals of the previous phase are achieved |
| accelerated rehabilitation protocol | Active comparator | Other: rehabilitation protocolIt's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft.
- Ranging in age from 18 to 35 years.
- Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility
- Ability to actively control the quadriceps.
Key exclusion criteria (6 listed)
- ACLR with any graft other than a hamstring graft
- ACL revision surgery
- associated medial or lateral ligamentous injuries
- previous meniscectomy or meniscal repair
- simultaneous meniscectomy or meniscus repair with the ACLR
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 |
|---|---|---|
| rehabilitation protocolrehabilitation protocols after ACLR have been described, aiming to improve muscle strength and knee stability through muscle strengthening exercises in addition to exercises to improve joint proprioception | Other | accelerated rehabilitation protocol, criterion-based rehabilitation protocol |
Primary outcome
Dynamic knee valgus during Single leg landing-jump test using CLINICAL CLIMA 3DMA
Time frame: 15 minutes
From the coronal plane, dynamic knee valgus is the angle of the knee
Lateral trunk flexion during Single leg landing-jump test using CLINICAL CLIMA 3DMA
Time frame: 15 minutes
From the coronal plane, trunk lateral flexion angle is the angle of the trunk
knee flexion angle during Single leg landing-jump test using CLINICAL CLIMA 3DMA
Time frame: 15 minutes
From sagittal plane, knee flexion angle is the angle of the knee
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Knee Injuries
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation protocol in people with Knee Injuries and Rehabilitation, run by Delta University for Science and Technology 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 4 inclusion and 6 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 23 Jan 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic knee valgus during Single leg landing-jump test using CLINICAL CLIMA 3DMA (time frame: 15 minutes). The study lists 3 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 23 Jan 2024.