Anterior Cruciate Ligament ReconstructionNCT02775188
interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction
A study testing interACTION in people with Anterior Cruciate Ligament Reconstruction, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to ascertain if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation following ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks during their outpatient physical therapy treatment. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- interACTION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 19 Jan 2018
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 15 to 30 years of age;
- Have undergone ACL Reconstruction;
- Being referred for post-operative outpatient physical therapy;
- Agree to and able to perform pre-designed exercises that they would normally perform in a physical therapy program after ACL Reconstruction.
Who cannot join
- Patients undergoing concomitant meniscal repair or other surgical procedure requiring modification of post-operative physical therapy program;
- Patients with BMI >40 at the time of surgery;
- Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of physical therapy exercises;
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to ascertain if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation following ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks during their outpatient physical therapy treatment. Subjects will undergo weekly physical therapy or weekly physical therapy paired with InterACTION.
- Being tested
- interACTION, Standard of Care Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interACTIONDevice
Standard of Care Physical TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy with InterACTION | Experimental | After ACL Reconstruction, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device. Receives: Device: interACTION |
| Physical Therapy | Other | After ACL Reconstruction, subjects will undergo physical therapy 1 time per week Receives: Other: Standard of Care Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value evaluated by the ratio of patient outcomes to costs of rehabilitation
Value will be evaluated by the ratio of patient outcomes to costs of rehabilitation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJul 2016
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Why it stopped: Because of technical and feasibility issues with InterACTION, the study to investigate the system for individuals following ACL reconstruction was terminated.
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 University of PittsburghThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James J. Irrgang, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775188
- Sponsor's protocol ID
- PRO16020108
- Status last verified
- Dec 2018
- First submitted
- 14 May 2016
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- interACTION: A Portable Joint Function Monitoring and Training System to Supplement Home Exercise Programs Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02775188
- Acronym / sponsor ID
- PRO16020108
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of technical and feasibility issues with InterACTION, the study to investigate the system for individuals following ACL reconstruction was terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 17 May 2016 (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 purpose of this study is to ascertain if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation following ACL reconstruction. Patients undergoing ACL Reconstruction will be followed for 6 weeks during their outpatient physical therapy treatment. Subjects will undergo weekly physical therapy or weekly physical therapy paired with InterACTION.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy with InterACTION | Experimental | Device: interACTIONAfter ACL Reconstruction, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device. |
| Physical Therapy | Other | Other: Standard of Care Physical TherapyAfter ACL Reconstruction, subjects will undergo physical therapy 1 time per week |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between 15 to 30 years of age;
- Have undergone ACL Reconstruction;
- Being referred for post-operative outpatient physical therapy;
- Agree to and able to perform pre-designed exercises that they would normally perform in a physical therapy program after ACL Reconstruction.
Key exclusion criteria (3 listed)
- Patients undergoing concomitant meniscal repair or other surgical procedure requiring modification of post-operative physical therapy program;
- Patients with BMI >40 at the time of surgery;
- Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of physical therapy exercises;
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 |
|---|---|---|
| interACTION | Device | Physical Therapy with InterACTION |
| Standard of Care Physical Therapy | Other | Physical Therapy |
Primary outcome
Value evaluated by the ratio of patient outcomes to costs of rehabilitation
Time frame: 6 weeks
Value will be evaluated by the ratio of patient outcomes to costs of rehabilitation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
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 interACTION in people with Anterior Cruciate Ligament Reconstruction, run by University of Pittsburgh at 1 site 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 4 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: withdrawn, as of the sponsor's last update on 11 Dec 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Value evaluated by the ratio of patient outcomes to costs of rehabilitation (time frame: 6 weeks). 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 11 Dec 2018.