Anterior Cruciate Ligament RuptureNCT04593264
Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
A study testing Self-guided pre-habilitation exercise program and Traditional pre-habilitation in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Tear, run by WellSpan Health at 1 site in United States.
Trial summary
Although the success of physical therapy following surgery has been well-documented and validated in patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) procedures, more recent studies have demonstrated that patient outcomes are the most favorable when surgery is delayed approximately 4 weeks until… Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries
- What is being tested?
- Self-guided pre-habilitation exercise program and Traditional pre-habilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 30 Jun 2022
- 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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Skeletal maturity
- Acute ACL rupture occurring no longer than 4 weeks prior to presentation
- Ability to participate in a pre-habilitation program
- Nature of the injury allows adequate time for pre-habilitation
- Ability to speak, read, and understand English
- Willing and able to provide informed consent
Who cannot join
- Any injuries requiring immediate surgical intervention
- Ipsilateral meniscus tear that preventing participation in a pre-habilitation program
- Ipsilateral MCL tears grade III
- Ipsilateral PCL tears (any grade)
- Concomitant LCL injuries
- Concomitant posterolateral corner injuries
Show all 9Show fewer
- Inflammatory arthritis
- Prior ACL rupture/reconstruction
- Anyone unable to participate in a stretching/strengthening program
Trial locations and contacts
1 site in 1 country.
About this study
Although the success of physical therapy following surgery has been well-documented and validated in patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) procedures, more recent studies have demonstrated that patient outcomes are the most favorable when surgery is delayed approximately 4 weeks until after the patient has completed a preoperative physical therapy program, or "pre-habilitation." The ultimate goal of pre-habilitation is to regain full range of motion in the knee and reach approximately 80% of pre-injury quadricep strength. However, extra physical therapy can stress both time and resources. Thus, we propose a home-based, self-guided pre-habilitation program. We hypothesize that patients participating in self-guided pre-habilitation will experience the same benefits as patients in a traditional office-based physical therapy program.
- Conditions
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries
- Being tested
- Self-guided pre-habilitation exercise program, Traditional pre-habilitation
- 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.
Self-guided pre-habilitation exercise programOther
A set of self-guided exercises developed by an athletic trainer to perform at home in order to optimize the knee for ACL repair surgery
Traditional pre-habilitationOther
Pre-habilitation exercise sessions under the direct supervision of a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Supervised Prehabilitation with a Physical Therapist | Active comparator | Not described Receives: Other: Traditional pre-habilitation |
| Self-guided Home-based Prehabilitation | Experimental | Not described Receives: Other: Self-guided pre-habilitation exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Ready for ACL repair surgery
The surgeon will decide if the patient's knee is optimized and ready for surgery based on quadricep circumference and range of motion.
Measured: Approximately 4 weeks following initiation of a pre-habilitation program
Secondary outcomes (2)
Knee Range of Motion
Difference in knee range of motion from baseline to final pre-operative check-in
Measured: Approximately 4 weeks following initiation of a pre-habilitation program
Thigh circumference
Difference in thigh circumference from baseline to final pre-operative check-in
Measured: Approximately 4 weeks following initiation of a pre-habilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start23 Feb 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Deitch, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593264
- Sponsor's protocol ID
- 1168599
- Status last verified
- Mar 2023
- First submitted
- 13 Oct 2020
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Benefits of Supervised vs. Unsupervised Pre-habilitation for Patients With Acute ACL Tears
- ClinicalTrials.gov ID
- NCT04593264
- Acronym / sponsor ID
- 1168599
- Conditions
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Oct 2020 (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.
Although the success of physical therapy following surgery has been well-documented and validated in patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) procedures, more recent studies have demonstrated that patient outcomes are the most favorable when surgery is delayed approximately 4 weeks until after the patient has completed a preoperative physical therapy program, or "pre-habilitation." The ultimate goal of pre-habilitation is to regain full range of motion in the knee and reach approximately 80% of pre-injury quadricep strength. However, extra physical therapy can stress both time and resources. Thus, we propose a home-based, self-guided pre-habilitation program. We hypothesize that patients participating in self-guided pre-habilitation will experience the same benefits as patients in a traditional office-based physical therapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Supervised Prehabilitation with a Physical Therapist | Active comparator | Other: Traditional pre-habilitation |
| Self-guided Home-based Prehabilitation | Experimental | Other: Self-guided pre-habilitation exercise program |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Skeletal maturity
- Acute ACL rupture occurring no longer than 4 weeks prior to presentation
- Ability to participate in a pre-habilitation program
- Nature of the injury allows adequate time for pre-habilitation
- Ability to speak, read, and understand English
Key exclusion criteria (9 listed)
- Any injuries requiring immediate surgical intervention
- Ipsilateral meniscus tear that preventing participation in a pre-habilitation program
- Ipsilateral MCL tears grade III
- Ipsilateral PCL tears (any grade)
- Concomitant LCL injuries
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 |
|---|---|---|
| Self-guided pre-habilitation exercise programA set of self-guided exercises developed by an athletic trainer to perform at home in order to optimize the knee for ACL repair surgery | Other | Self-guided Home-based Prehabilitation |
| Traditional pre-habilitationPre-habilitation exercise sessions under the direct supervision of a physical therapist. | Other | Traditional Supervised Prehabilitation with a Physical Therapist |
Primary outcome
Number of Participants Ready for ACL repair surgery
Time frame: Approximately 4 weeks following initiation of a pre-habilitation program
The surgeon will decide if the patient's knee is optimized and ready for surgery based on quadricep circumference and range of motion.
2 secondary outcomes
Knee Range of Motion
Time frame: Approximately 4 weeks following initiation of a pre-habilitation program
Thigh circumference
Time frame: Approximately 4 weeks following initiation of a pre-habilitation program
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 27 Mar 2023.
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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 Self-guided pre-habilitation exercise program and Traditional pre-habilitation in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Tear, run by WellSpan Health 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 6 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 27 Mar 2023. 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 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?
Number of Participants Ready for ACL repair surgery (time frame: Approximately 4 weeks following initiation of a pre-habilitation program). 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 27 Mar 2023.