Muscle WeaknessNCT02300636
Resistive Co-contraction Training After Anterior Cruciate Ligament Reconstruction
A study testing Training in people with Muscle Weakness, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates different resistive co-contraction trainings effect on knee strength recovery after ACL reconstruction. Participants will be divided into three groups. Group 1 will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic chain position, Group 2 will receive… Read more about this study
- Who is it for?
- Ages 17 to 40 years, men only
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Mar 2015
- 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 17 to 40 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- ACL reconstruction with hamstring autograft
- starting PT program within one week after surgery
Who cannot join
- Revision surgery
- serious cartilage damage and/or cartilage repair
- ACL reconstruction with allograft and patellar tendon graft
- Having systemic and/or neurological problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Department of Physiotherapy and Rehabilitation
Ankara, 06100
About this study
Official title: Randomized-controlled,Resistive Co-contraction Training Enhances Strength Recovery After Anterior Cruciate Ligament Reconstruction
This study investigates different resistive co-contraction trainings effect on knee strength recovery after ACL reconstruction. Participants will be divided into three groups. Group 1 will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic chain position, Group 2 will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic chain position and Group 3 (control group) will only receive standard ACL rehabilitation.
Read the detailed description
Co-contraction trainings can enhance joint stability via improving proprioceptive ability and stimulates muscle activity after injury and/or surgery. The participants will be assigned to the different groups one month after surgery. They will receive 8-week-treatment. Isometric strength of quadriceps and hamstring muscles will be measured at first,third and sixth months after surgery. Concentric and eccentric strength of quadriceps and hamstring muscles will be measured only at sixth months after surgery.
- Conditions
- Muscle Weakness
- Being tested
- Training
- Keywords
- Knee joint, Muscle strength, anterior cruciate ligament
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Co-contraction training at 60 knee flexion angle by using isokinetic dynamometer
TrainingOther
Co-contraction training at 60 knee flexion angle by using leg press machine
TrainingOther
Standard ACL rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Training: open kinetic | Experimental | Co-contraction training in open kinetic chain position
8 weeks, 3 days in a week Receives: Other: Training |
| Training: closed kinetic | Experimental | Co-contraction training in closed kinetic chain position
8 weeks, 3 days in a week Receives: Other: Training |
| Training: Standard ACL rehabilitation | Active comparator | Standard ACL rehabilitation
8 weeks, 3 days in a week Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee muscle strength recovery
isometric, concentric and eccentric strength
Measured: 8 weeks
Secondary outcomes (1)
hamstring quadriceps ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GULCAN HARPUT, Hacettepe University
- Investigators
- GULCAN HARPUT, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300636
- Sponsor's protocol ID
- 014T03102002
- Status last verified
- Mar 2015
- First submitted
- 21 Nov 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho SH, Bae CH, Gak HB. Effects of closed kinetic chain exercises on proprioception and functional scores of the knee after anterior cruciate ligament reconstruction. J Phys Ther Sci. 2013 Oct;25(10):1239-41. doi: 10.1589/jpts.25.1239. Epub 2013 Nov 20.
PubMed 24259766Lobb R, Tumilty S, Claydon LS. A review of systematic reviews on anterior cruciate ligament reconstruction rehabilitation. Phys Ther Sport. 2012 Nov;13(4):270-8. doi: 10.1016/j.ptsp.2012.05.001. Epub 2012 Jun 7.
PubMed 23068905Begalle RL, Distefano LJ, Blackburn T, Padua DA. Quadriceps and hamstrings coactivation during common therapeutic exercises. J Athl Train. 2012 Jul-Aug;47(4):396-405. doi: 10.4085/1062-6050-47.4.01.
PubMed 22889655Glass R, Waddell J, Hoogenboom B. The Effects of Open versus Closed Kinetic Chain Exercises on Patients with ACL Deficient or Reconstructed Knees: A Systematic Review. N Am J Sports Phys Ther. 2010 Jun;5(2):74-84.
PubMed 21589664Tagesson S, Oberg B, Good L, Kvist J. A comprehensive rehabilitation program with quadriceps strengthening in closed versus open kinetic chain exercise in patients with anterior cruciate ligament deficiency: a randomized clinical trial evaluating dynamic tibial translation and muscle function. Am J Sports Med. 2008 Feb;36(2):298-307. doi: 10.1177/0363546507307867. Epub 2007 Oct 16.
PubMed 17940146Biscarini A, Benvenuti P, Botti FM, Brunetti A, Brunetti O, Pettorossi VE. Voluntary enhanced cocontraction of hamstring muscles during open kinetic chain leg extension exercise: its potential unloading effect on the anterior cruciate ligament. Am J Sports Med. 2014 Sep;42(9):2103-12. doi: 10.1177/0363546514536137. Epub 2014 Jun 10.
PubMed 24918112Palmieri-Smith RM, McLean SG, Ashton-Miller JA, Wojtys EM. Association of quadriceps and hamstrings cocontraction patterns with knee joint loading. J Athl Train. 2009 May-Jun;44(3):256-63. doi: 10.4085/1062-6050-44.3.256.
PubMed 19478837
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled,Resistive Co-contraction Training Enhances Strength Recovery After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02300636
- Acronym / sponsor ID
- 014T03102002
- Conditions
- Muscle Weakness
- Keywords
- Knee joint, Muscle strength, anterior cruciate ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Nov 2014 (estimated)
- 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 investigates different resistive co-contraction trainings effect on knee strength recovery after ACL reconstruction. Participants will be divided into three groups. Group 1 will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic chain position, Group 2 will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic chain position and Group 3 (control group) will only receive standard ACL rehabilitation.
Detailed description
Co-contraction trainings can enhance joint stability via improving proprioceptive ability and stimulates muscle activity after injury and/or surgery. The participants will be assigned to the different groups one month after surgery. They will receive 8-week-treatment. Isometric strength of quadriceps and hamstring muscles will be measured at first,third and sixth months after surgery. Concentric and eccentric strength of quadriceps and hamstring muscles will be measured only at sixth months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training: open kinetic | Experimental | Other: TrainingCo-contraction training in open kinetic chain position 8 weeks, 3 days in a week |
| Training: closed kinetic | Experimental | Other: TrainingCo-contraction training in closed kinetic chain position 8 weeks, 3 days in a week |
| Training: Standard ACL rehabilitation | Active comparator | Other: TrainingStandard ACL rehabilitation 8 weeks, 3 days in a week |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ACL reconstruction with hamstring autograft
- starting PT program within one week after surgery
Key exclusion criteria (4 listed)
- Revision surgery
- serious cartilage damage and/or cartilage repair
- ACL reconstruction with allograft and patellar tendon graft
- Having systemic and/or neurological problems
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 |
|---|---|---|
| TrainingCo-contraction training at 60 knee flexion angle by using isokinetic dynamometer | Other | Training: open kinetic |
| TrainingCo-contraction training at 60 knee flexion angle by using leg press machine | Other | Training: closed kinetic |
| TrainingStandard ACL rehabilitation | Other | Training: Standard ACL rehabilitation |
Primary outcome
knee muscle strength recovery
Time frame: 8 weeks
isometric, concentric and eccentric strength
1 secondary outcome
hamstring quadriceps ratio
Time frame: 6 months
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 18 Mar 2015.
- Background: PubMed 24259766Cho SH, Bae CH, Gak HB. Effects of closed kinetic chain exercises on proprioception and functional scores of the knee after anterior cruciate ligament reconstruction. J Phys Ther Sci. 2013 Oct;25(10):1239-41. doi: 10.1589/jpts.25.1239. Epub 2013 Nov 20.
- Background: PubMed 23068905Lobb R, Tumilty S, Claydon LS. A review of systematic reviews on anterior cruciate ligament reconstruction rehabilitation. Phys Ther Sport. 2012 Nov;13(4):270-8. doi: 10.1016/j.ptsp.2012.05.001. Epub 2012 Jun 7.
- Background: PubMed 22889655Begalle RL, Distefano LJ, Blackburn T, Padua DA. Quadriceps and hamstrings coactivation during common therapeutic exercises. J Athl Train. 2012 Jul-Aug;47(4):396-405. doi: 10.4085/1062-6050-47.4.01.
- Background: PubMed 21589664Glass R, Waddell J, Hoogenboom B. The Effects of Open versus Closed Kinetic Chain Exercises on Patients with ACL Deficient or Reconstructed Knees: A Systematic Review. N Am J Sports Phys Ther. 2010 Jun;5(2):74-84.
- Background: PubMed 17940146Tagesson S, Oberg B, Good L, Kvist J. A comprehensive rehabilitation program with quadriceps strengthening in closed versus open kinetic chain exercise in patients with anterior cruciate ligament deficiency: a randomized clinical trial evaluating dynamic tibial translation and muscle function. Am J Sports Med. 2008 Feb;36(2):298-307. doi: 10.1177/0363546507307867. Epub 2007 Oct 16.
- Background: PubMed 24918112Biscarini A, Benvenuti P, Botti FM, Brunetti A, Brunetti O, Pettorossi VE. Voluntary enhanced cocontraction of hamstring muscles during open kinetic chain leg extension exercise: its potential unloading effect on the anterior cruciate ligament. Am J Sports Med. 2014 Sep;42(9):2103-12. doi: 10.1177/0363546514536137. Epub 2014 Jun 10.
- Background: PubMed 19478837Palmieri-Smith RM, McLean SG, Ashton-Miller JA, Wojtys EM. Association of quadriceps and hamstrings cocontraction patterns with knee joint loading. J Athl Train. 2009 May-Jun;44(3):256-63. doi: 10.4085/1062-6050-44.3.256.
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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.
GULCAN HARPUT, MSc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Muscle Weakness, 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 2 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 18 Mar 2015. 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?
knee muscle strength recovery (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02300636, which also lists 7 linked publications.
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 2015.