Anterior Cruciate Ligament ReconstructionNCT03304561
The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction
A study testing Traditional rehabilitation and Cross-over training in people with Anterior Cruciate Ligament Reconstruction, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Traditional rehabilitation and Cross-over training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2016to 30 Oct 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having surgery of ACL reconstruction on one side
- having no problem at least six month on the nonsrgical side
- recieving the rehabilitation programme at hacettepe university, physiotherapy department
Who cannot join
- refusing to include to the study
- having revision ACL surgery
- addition of PCL or cartilage surgery addition to the ACL surgery
- not participating to the rehabilidation program regularly over 3 month after sugery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contralateral Strength Training Effects on Functional Outcomes in Patients Who Had Undergone ACL Reconstruction: Randomized Controlled Trial
Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps
Read the detailed description
Returning to sport after ACL reconstruction is not at desired level among athletes. Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction. Cross-over training is recomended during rehabilitation after ACL reconstrucion. Yet duration of the training, frequancy and type of exercise interention are not clear for the cross-over training. Ain of the study is to investigate the effects of cross-over training on muscle strenght
- Being tested
- Traditional rehabilitation, Cross-over training
- Keywords
- knee, rehabilitation, ACL, Contralateral training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional rehabilitationOther
Also called Standard post-operative ACL rehabilidation program
traditional ACL rehabilitation program
Cross-over trainingOther
Cross-over training addition to the traditional rehabilidation
| Study group | Role | What they receive |
|---|---|---|
| traditional rehabilitation | Experimental | patients in this groups is going to recieve traditional rehabilitation programme for 3 months after ACL recontsruction Receives: Other: Traditional rehabilitation |
| Cross-over training | Experimental | patients in this programme is going to recieve isokinetic exercise programme targeting unilvolved limb during rehabilitation. for the first 4 weeks after ACL reconstruction traditional rehabiitation programme is going to applied to the subjects. after 4 weeks, isokinetic strenghtening programme at 60˚/second angular velocity, between 0-90 degree knee flexion until 3 months after ACL reconstructon Receives: Other: Cross-over training |
What is being measured
The primary outcome is the main question the study is designed to answer.
quadriceps and hamstring muscle strenght
quadriceps strength change during the first, second and sixth months of the rehabilitation proccess after ACL reconstruction surgery. the strength measurements will conducted on isokinetic dynamometer (isomed 2000)
Measured: 6 month
Secondary outcomes (1)
functional outcomes
one leg hop test, vertical jump test on the sixth month after surgery. the functional outcomes will be measured only at the sixth month after surgery.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Oct 2016
- Primary completion1 Aug 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GULCAN HARPUT, Hacettepe University
- Investigators
- volga tunay, PhD, Study director, volgamel@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304561
- Sponsor's protocol ID
- 123456
- Status last verified
- Jan 2018
- First submitted
- 4 Oct 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralateral Strength Training Effects on Functional Outcomes in Patients Who Had Undergone ACL Reconstruction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03304561
- Acronym / sponsor ID
- 123456
- Keywords
- knee, rehabilitation, ACL, Contralateral training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 9 Oct 2017 (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.
Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps
Detailed description
Returning to sport after ACL reconstruction is not at desired level among athletes. Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction. Cross-over training is recomended during rehabilitation after ACL reconstrucion. Yet duration of the training, frequancy and type of exercise interention are not clear for the cross-over training. Ain of the study is to investigate the effects of cross-over training on muscle strenght
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional rehabilitation | Experimental | Other: Traditional rehabilitationpatients in this groups is going to recieve traditional rehabilitation programme for 3 months after ACL recontsruction |
| Cross-over training | Experimental | Other: Cross-over trainingpatients in this programme is going to recieve isokinetic exercise programme targeting unilvolved limb during rehabilitation. for the first 4 weeks after ACL reconstruction traditional rehabiitation programme is going to applied to the subjects. after 4 weeks, isokinetic strenghtening programme at 60˚/second angular velocity, between 0-90 degree knee flexion until 3 months after ACL reconstructon |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- having surgery of ACL reconstruction on one side
- having no problem at least six month on the nonsrgical side
- recieving the rehabilitation programme at hacettepe university, physiotherapy department
Key exclusion criteria (4 listed)
- refusing to include to the study
- having revision ACL surgery
- addition of PCL or cartilage surgery addition to the ACL surgery
- not participating to the rehabilidation program regularly over 3 month after sugery
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 |
|---|---|---|
| Traditional rehabilitationAlso: Standard post-operative ACL rehabilidation programtraditional ACL rehabilitation program | Other | traditional rehabilitation |
| Cross-over trainingCross-over training addition to the traditional rehabilidation | Other | Cross-over training |
Primary outcome
quadriceps and hamstring muscle strenght
Time frame: 6 month
quadriceps strength change during the first, second and sixth months of the rehabilitation proccess after ACL reconstruction surgery. the strength measurements will conducted on isokinetic dynamometer (isomed 2000)
1 secondary outcome
functional outcomes
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
volga tunay, PhD study director
volgamel@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional rehabilitation and Cross-over training in people with Anterior Cruciate Ligament Reconstruction, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Feb 2018. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
quadriceps and hamstring muscle strenght (time frame: 6 month). 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 5 Feb 2018.