ACL InjuryNCT03243162
Improving ACL Reconstruction Outcomes: CBPT
A study testing CBPT-ACLR and Education in people with ACL Injury and ACL - Anterior Cruciate Ligament Rupture, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
The overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function, return to sport, and quality of life outcomes in patients following ACL reconstruction (ACLR). Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL Sprain
- What is being tested?
- CBPT-ACLR and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 17 Apr 2020
- 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 14 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention);
- 14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and younger are less likely to have symptoms of knee osteoarthritis);
- no previous surgery to either knee;
- time from injury to surgery 12 months or less;
- active participation in a sport on a weekly basis prior to injury
Who cannot join
- bilateral simultaneous ACL reconstructions;
- revision ACLR;
- any concurrent ligament (MCL, LCL, or PCL) surgical procedures;
- concurrent osteotomies or meniscus transplantations;
- surgery secondary to trauma, tumor, or infection;
- having workman's compensation insurance for surgery;
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- on active military duty;
- medical history of schizophrenia or other psychotic disorder; and
- unable to provide stable address and access to a telephone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic
Garfield Heights, Ohio, 44125
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
The overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function, return to sport, and quality of life outcomes in patients following ACL reconstruction (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central hypothesis is that the CBPT-ACLR participants relative to the Education group will demonstrate significantly greater improvement in postoperative outcomes at 12 months following surgery.
- Being tested
- CBPT-ACLR, Education
- 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.
CBPT-ACLRBehavioural
The CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist.
EducationOther
The education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist.
| Study group | Role | What they receive |
|---|---|---|
| CBPT-ACLR | Experimental | CBPT-ACLR program consisting of weekly phone calls. Receives: Behavioral: CBPT-ACLR |
| Education | Active comparator | Education program consisting of weekly phone calls. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
knee function relating to sport/recreation
Measured: Up to 12 months after ACLR surgery
Marx Activity Rating Scale
The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.
Measured: Up to 12 months after ACLR surgery
Secondary outcomes (3)
Subjective Patient Outcome for Return to Sports (SPORTS)
The SPORTS score measures 1) ability to perform the same sport with the same level of effort, 2) ability to reach the same level of performance, and 3) ability to perform with no pain or in spite of the pain.
Measured: Up to 12 months after ACLR surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale
knee function relating to quality of life
Measured: Up to 12 months after ACLR surgery
EQ-5D
The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.
Measured: Up to 12 months after ACLR surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jul 2017
- Primary completion18 Feb 2020
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Kristin Archer, Vanderbilt University Medical Center
- Investigators
- Kristin Archer, PhD, DPT, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243162
- Sponsor's protocol ID
- 161927
- Status last verified
- May 2020
- First submitted
- 4 Aug 2017
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
- ClinicalTrials.gov ID
- NCT03243162
- Acronym / sponsor ID
- 161927
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 8 Aug 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.
The overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function, return to sport, and quality of life outcomes in patients following ACL reconstruction (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central hypothesis is that the CBPT-ACLR participants relative to the Education group will demonstrate significantly greater improvement in postoperative outcomes at 12 months following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBPT-ACLR | Experimental | Behavioral: CBPT-ACLRCBPT-ACLR program consisting of weekly phone calls. |
| Education | Active comparator | Other: EducationEducation program consisting of weekly phone calls. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention);
- 14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and younger are less likely to have symptoms of knee osteoarthritis);
- no previous surgery to either knee;
- time from injury to surgery 12 months or less;
- active participation in a sport on a weekly basis prior to injury
Key exclusion criteria (9 listed)
- bilateral simultaneous ACL reconstructions;
- revision ACLR;
- any concurrent ligament (MCL, LCL, or PCL) surgical procedures;
- concurrent osteotomies or meniscus transplantations;
- surgery secondary to trauma, tumor, or infection;
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 |
|---|---|---|
| CBPT-ACLRThe CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist. | Behavioural | CBPT-ACLR |
| EducationThe education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist. | Other | Education |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
Time frame: Up to 12 months after ACLR surgery
knee function relating to sport/recreation
Marx Activity Rating Scale
Time frame: Up to 12 months after ACLR surgery
The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.
3 secondary outcomes
Subjective Patient Outcome for Return to Sports (SPORTS)
Time frame: Up to 12 months after ACLR surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale
Time frame: Up to 12 months after ACLR surgery
EQ-5D
Time frame: Up to 12 months after ACLR surgery
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 20 May 2020.
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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.
Kristin Archer, PhD, DPT principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBPT-ACLR and Education in people with ACL Injury and ACL - Anterior Cruciate Ligament Rupture, run by Vanderbilt University Medical Center at 2 sites in United States.
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 5 inclusion and 9 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 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale (time frame: Up to 12 months after ACLR surgery). 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 20 May 2020.