ACL InjuryNCT04541940
TeleRehabilitation Following ACL Reconstruction
A study testing Telerehabilitation Therapy and In-person Rehabilitation Therapy in people with ACL Injury, run by NYU Langone Health at 1 site in United States.
Trial summary
Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Telerehabilitation Therapy and In-person Rehabilitation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Nov 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for ACL reconstruction
- Age 18-40
- Ability to comply with a standardized postoperative protocol
- Willing and able to provide consent
Who cannot join
- Pregnant patient
- Age >40 years, or < 18
- Previous knee surgery
- Unable to speak English or perform informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.
The purpose of the proposed study is to evaluate telerehabilitation vs. in-person rehabilitation following ACL reconstruction. Objectives include assess return to sport and patient reported functional outcomes.
- Conditions
- ACL Injury
- Being tested
- Telerehabilitation Therapy, In-person Rehabilitation Therapy
- 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.
Telerehabilitation TherapyOther
Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.
In-person Rehabilitation TherapyOther
Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Active comparator | Not described Receives: Other: Telerehabilitation Therapy |
| In-Person Rehabilitation | Active comparator | Not described Receives: Other: In-person Rehabilitation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
RTS (Return to Sport)
The day when the participant is able to fully participate in their sport, but not at their desired performance level.
Measured: up to 1 year post-op
Secondary outcomes (4)
ACL-RSI Questionnaire Score
ACL-RSI (anterior cruciate ligament - return to sport) consists of 12 questions. Each question is scored 0-100 with a total range of 0-1200. The higher the score, the more positive psychological outlook a participant has.
Measured: up to 1 year post-op
Visual Analogue Scale (VAS) Score
VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The total score ranges from 0-10. The higher the score, the worse the pain.
Measured: up to 1 year post-op
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a knee-specific instrument, developed to assess the participants' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales. Each subscale is calculated independently. The calculated mean score of the individual items of each subscale will be divided by 4. The total score range is 0-100. The lower the score, the more extreme the problems.
Measured: up to 1 year post-op
International Knee Documentation Committee (IKDC) Score
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: up to 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2021
- Study completion30 Nov 2021
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 NYU Langone HealthThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirk Campbell, MD, Principal investigator, kirk.campbell@nyulangone.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541940
- Sponsor's protocol ID
- 20-01260
- Status last verified
- Jun 2022
- First submitted
- 2 Sep 2020
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleRehabilitation Following ACL Reconstruction
- ClinicalTrials.gov ID
- NCT04541940
- Acronym / sponsor ID
- 20-01260
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 Sep 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.
Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.
The purpose of the proposed study is to evaluate telerehabilitation vs. in-person rehabilitation following ACL reconstruction. Objectives include assess return to sport and patient reported functional outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Active comparator | Other: Telerehabilitation Therapy |
| In-Person Rehabilitation | Active comparator | Other: In-person Rehabilitation Therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Scheduled for ACL reconstruction
- Age 18-40
- Ability to comply with a standardized postoperative protocol
- Willing and able to provide consent
Key exclusion criteria (4 listed)
- Pregnant patient
- Age >40 years, or < 18
- Previous knee surgery
- Unable to speak English or perform informed consent
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 |
|---|---|---|
| Telerehabilitation TherapyRehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - Quadriceps isometrics exercises, straight leg raises, and range of motion exercises. | Other | Telerehabilitation |
| In-person Rehabilitation TherapyQuadriceps isometrics exercises, straight leg raises, and range of motion exercises. | Other | In-Person Rehabilitation |
Primary outcome
RTS (Return to Sport)
Time frame: up to 1 year post-op
The day when the participant is able to fully participate in their sport, but not at their desired performance level.
4 secondary outcomes
ACL-RSI Questionnaire Score
Time frame: up to 1 year post-op
Visual Analogue Scale (VAS) Score
Time frame: up to 1 year post-op
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: up to 1 year post-op
International Knee Documentation Committee (IKDC) Score
Time frame: up to 1 year post-op
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 1 Jul 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
Kirk Campbell, MD principal investigator
kirk.campbell@nyulangone.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Therapy and In-person Rehabilitation Therapy in people with ACL Injury, run by NYU Langone 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 4 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 1 Jul 2022. 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?
RTS (Return to Sport) (time frame: up to 1 year post-op). 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 1 Jul 2022.