RehabilitationNCT01821599
Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament.
A study testing Nonaccelerated Rehabilitation and Accelerated Rehabilitation in people with Rehabilitation and Anterior Cruciate Ligament Reconstruction, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The accelerated rehabilitation and early return does not seem to be harmful, but still needs further research to define the rehabilitation time is what shows Kruse and collaborators (2012) in their study of systematic review. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Rehabilitation, Anterior Cruciate Ligament Reconstruction, Knee
- What is being tested?
- Nonaccelerated Rehabilitation and Accelerated Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Apr 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- With diagnosis of injury (primary) anterior cruciate ligament confirmed by magnetic resonance may or may not be associated with a meniscal injury or partial ligament medial collateral ligament (MCL) surgery is not indicated.
- Patients undergo surgery for anterior cruciate ligament reconstruction using patellar tendon.
Who cannot join
- Patients who had changes in diagnosis during surgery.
- Surgical complications
- Patients with More than 30% of lack or abandon physiotherapy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Orthopedics and Traumatology, Faculty of Medicine of São Paulo
São Paulo, São Paulo, 03403-010
About this study
The accelerated rehabilitation and early return does not seem to be harmful, but still needs further research to define the rehabilitation time is what shows Kruse and collaborators (2012) in their study of systematic review. The surgical treatment of anterior cruciate ligament injury is the gold standard in the treatment of these injuries in young and active, the postoperative rehabilitation is extensive and full return to sport occurs only after 6 months postoperatively. Based on this gap, the investigators seek to draw properly through our study methods and more complex techniques, that comparing two rehabilitation programs can achieve high precision early rehabilitation. This will include 32 athletes who had complete ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All subjects will be followed from the pre-surgery, the fourth and sixth month after surgery with: KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a random draw of sealed envelopes, patients will be allocated in their rehabilitation groups: Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to treatment group. This study will have the locus Institute of Orthopaedics and Traumatology, School of Medicine, São Paulo. The comparative results of the two groups are analyzed using specific statistical tests to prove an improved significative without damaging the integrity of the graft.
Read the detailed description
All subjects will be followed for a period of six months. During this period will undergo three stages of evaluation.
- º Preoperative up to two years following injury : assessment will consist KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Hop Test (jumps with one leg); Isokinetic Muscle Strength (Cybex).
- º 4º months pós-surgery KT1000, International Knee Documentation Committee (IKDC 2000); Hop Test; Isokinetic Muscle Strength (Cybex)
- º 6º months postoperatively KT1000, International Knee Documentation Committee (IKDC) + Hop Test; Isokinetic Muscle Strength (Cybex)
- Being tested
- Nonaccelerated Rehabilitation, Accelerated Rehabilitation
- Keywords
- Anterior Cruciate Ligament, Knee, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonaccelerated RehabilitationOther
Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 6 months of recovery.
Accelerated RehabilitationOther
Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 4 months of recovery.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction Receives: Other: Nonaccelerated Rehabilitation |
| Accelerated group | Experimental | Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction Receives: Other: Accelerated Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
KT1000 measures
Measure of anterior knee stability
Measured: Sixth months
Secondary outcomes (3)
International Knee Documentation Committee (IKDC 2000)
Questionnaire function subjective of the knee
Measured: Sixth months
Hop Test measures
Jump with one leg
Measured: sixth months
Isokinetic of the knee measures
Knee Muscle Strength (Cybex).
Measured: sixth months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Carlos Alves Fabrício Júnior, University of Sao Paulo
- Investigators
- José Carlos Fabrício, Principal investigator, University of Sao PauloRoberto Mota, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821599
- Sponsor's protocol ID
- LCA-9090
- Status last verified
- Dec 2014
- First submitted
- 20 Mar 2013
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament.
- ClinicalTrials.gov ID
- NCT01821599
- Acronym / sponsor ID
- LCA-9090
- Keywords
- Anterior Cruciate Ligament, Knee, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Apr 2013 (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.
The accelerated rehabilitation and early return does not seem to be harmful, but still needs further research to define the rehabilitation time is what shows Kruse and collaborators (2012) in their study of systematic review. The surgical treatment of anterior cruciate ligament injury is the gold standard in the treatment of these injuries in young and active, the postoperative rehabilitation is extensive and full return to sport occurs only after 6 months postoperatively. Based on this gap, the investigators seek to draw properly through our study methods and more complex techniques, that comparing two rehabilitation programs can achieve high precision early rehabilitation. This will include 32 athletes who had complete ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All subjects will be followed from the pre-surgery, the fourth and sixth month after surgery with: KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a random draw of sealed envelopes, patients will be allocated in their rehabilitation groups: Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to treatment group. This study will have the locus Institute of Orthopaedics and Traumatology, School of Medicine, São Paulo. The comparative results of the two groups are analyzed using specific statistical tests to prove an improved significative without damaging the integrity of the graft.
Detailed description
All subjects will be followed for a period of six months. During this period will undergo three stages of evaluation.
- º Preoperative up to two years following injury : assessment will consist KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Hop Test (jumps with one leg); Isokinetic Muscle Strength (Cybex).
- º 4º months pós-surgery KT1000, International Knee Documentation Committee (IKDC 2000); Hop Test; Isokinetic Muscle Strength (Cybex)
- º 6º months postoperatively KT1000, International Knee Documentation Committee (IKDC) + Hop Test; Isokinetic Muscle Strength (Cybex)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Other: Nonaccelerated RehabilitationNonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction |
| Accelerated group | Experimental | Other: Accelerated RehabilitationAccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- With diagnosis of injury (primary) anterior cruciate ligament confirmed by magnetic resonance may or may not be associated with a meniscal injury or partial ligament medial collateral ligament (MCL) surgery is not indicated.
- Patients undergo surgery for anterior cruciate ligament reconstruction using patellar tendon.
Key exclusion criteria (3 listed)
- Patients who had changes in diagnosis during surgery.
- Surgical complications
- Patients with More than 30% of lack or abandon physiotherapy.
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 |
|---|---|---|
| Nonaccelerated RehabilitationNonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 6 months of recovery. | Other | Conventional group |
| Accelerated RehabilitationAccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 4 months of recovery. | Other | Accelerated group |
Primary outcome
KT1000 measures
Time frame: Sixth months
Measure of anterior knee stability
3 secondary outcomes
International Knee Documentation Committee (IKDC 2000)
Time frame: Sixth months
Hop Test measures
Time frame: sixth months
Isokinetic of the knee measures
Time frame: sixth 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 14 Apr 2015.
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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.
José Carlos Fabrício principal investigator
University of Sao Paulo
Roberto Mota study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonaccelerated Rehabilitation and Accelerated Rehabilitation in people with Rehabilitation and Anterior Cruciate Ligament Reconstruction, run by University of Sao Paulo at 1 site in Brazil.
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: finished, as of the sponsor's last update on 14 Apr 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 Brazil. 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?
KT1000 measures (time frame: Sixth months). 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 14 Apr 2015.