Rotator Cuff InjuriesNCT04541953
TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
A study testing Telerehabilitation Therapy and In-person Rehabilitation Therapy in people with Rotator Cuff Injuries, 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 40 to 80 years
- Conditions the study is for
- Rotator Cuff Injuries
- 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2020to 1 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo Rotator Cuff repair
- Age 40-80
- Ability to comply with a standardized postoperative protocol
- Willing and able to provide consent
Who cannot join
- Pregnant patient
- Age <40 years
- Previous shoulder 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 research study is to compare two standard of care rehabilitation methods (telerehabilitation vs in-person rehabilitation) following routine rotator cuff repair. Objectives include assessing range of motion and patient reported functional outcomes.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Telerehabilitation Therapy, In-person Rehabilitation Therapy
- Medical subject headings
- Rotator Cuff 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 - range of motion exercises and stretching.
In-person Rehabilitation TherapyOther
Range of motion exercises and stretching
| 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.
Level of Range of Motion
Active and passive range of motions will be tested in participants: forward flexion, abduction and internal/external rotation at 0° and 90°.
Measured: up to 1 year post-op
Secondary outcomes (2)
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
American Shoulder and Elbow Surgeons (ASES) Questionnaire Score
The ASES score contains a physician-rated and patient-rated section; however, only the pain visual analog scale (VAS) and 10 functional questions will be used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. The final pain score (maximum 50 points) is calculated by subtracting the VAS from 10 and multiplying by five. For the functional portion, each of 10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 points. The raw score is multiplied by 5/3 to make the maximal functional score out of 50 possible points. The pain and functional portions are then summed to obtain the final ASES score. The higher the score, the worse the pain and level of function.
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 start16 Sep 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies 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
- 32 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
- NCT04541953
- Sponsor's protocol ID
- 20-01261
- Status last verified
- Jul 2022
- First submitted
- 2 Sep 2020
- Last updated
- 15 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT04541953
- Acronym / sponsor ID
- 20-01261
- Conditions
- Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (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 research study is to compare two standard of care rehabilitation methods (telerehabilitation vs in-person rehabilitation) following routine rotator cuff repair. Objectives include assessing range of motion 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
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo Rotator Cuff repair
- Age 40-80
- Ability to comply with a standardized postoperative protocol
- Willing and able to provide consent
Key exclusion criteria (4 listed)
- Pregnant patient
- Age <40 years
- Previous shoulder 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 and stretching. | Other | Telerehabilitation |
| In-person Rehabilitation TherapyRange of motion exercises and stretching | Other | In-Person Rehabilitation |
Primary outcome
Level of Range of Motion
Time frame: up to 1 year post-op
Active and passive range of motions will be tested in participants: forward flexion, abduction and internal/external rotation at 0° and 90°.
2 secondary outcomes
Visual Analogue Scale (VAS) Score
Time frame: up to 1 year post-op
American Shoulder and Elbow Surgeons (ASES) Questionnaire 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 15 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.
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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.
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 Rotator Cuff Injuries, 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 15 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?
Level of Range of Motion (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 15 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.