MeniscectomyNCT04644640
Telerehabilitation Following Meniscectomy
A study testing Telerehabilitation Therapy and In-person Rehabilitation Therapy in people with Meniscectomy, 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 75 years
- Conditions the study is for
- Meniscectomy
- 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 1 Apr 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for meniscectomy
- Age 18-75
- Ability to comply with a standardized postoperative protocol
- Willing and able to provide consent
Who cannot join
- Pregnant patient
- Age >75 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
Official title: Telerehabilitation Following Meniscectomy: A Randomized Clinical Trial
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. Since telerehabilitation was found to be equally effective as conventional therapy, it was being practiced even before the COVID times, however it was truly valuable during the lockdown. 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 Meniscectomy.
- Conditions
- Meniscectomy
- Being tested
- Telerehabilitation Therapy, In-person Rehabilitation Therapy
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 - range of motion exercises for the knee, proprioception and balance training
In-person Rehabilitation TherapyOther
Range of motion exercises for the knee, proprioception and balance training
| 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.
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
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 posted25 Nov 2020
- Study start11 Nov 2020
- Primary completion30 Aug 2021
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeniscectomyStudies 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
- 60 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, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644640
- Sponsor's protocol ID
- 20-01584
- Status last verified
- May 2023
- First submitted
- 20 Nov 2020
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Following Meniscectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04644640
- Acronym / sponsor ID
- 20-01584
- Conditions
- Meniscectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 25 Nov 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. Since telerehabilitation was found to be equally effective as conventional therapy, it was being practiced even before the COVID times, however it was truly valuable during the lockdown. 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 Meniscectomy.
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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for meniscectomy
- Age 18-75
- Ability to comply with a standardized postoperative protocol
- Willing and able to provide consent
Key exclusion criteria (4 listed)
- Pregnant patient
- Age >75 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 - range of motion exercises for the knee, proprioception and balance training | Other | Telerehabilitation |
| In-person Rehabilitation TherapyRange of motion exercises for the knee, proprioception and balance training | Other | In-Person Rehabilitation |
Primary outcome
Visual Analogue Scale (VAS) Score
Time frame: up to 1 year post-op
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.
International Knee Documentation Committee (IKDC) Score
Time frame: up to 1 year post-op
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).
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 3 May 2023.
- 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 Meniscectomy
RecruitingObservational study
Assessment of the Degree of Regeneration After Partial Meniscectomy Based on Thin-layer MRI Image Segmentation and Reconstruction
Meniscus Regeneration, Partial Meniscectomy
Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Meniscus Tear
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
Recruiting
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Chondral Lesion of the Knee, Meniscal Injuries
Active, not recruitingPhase 4
Corticosteroid Meniscectomy Randomized Trial
Osteoarthritis, Knee, Meniscus Tear
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
NYU Langone Health
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 Meniscectomy, 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 3 May 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?
Visual Analogue Scale (VAS) Score (time frame: up to 1 year post-op). 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 3 May 2023.