Rotator Cuff SyndromeTFRCSACNCT06194435
Teleexercise for Rotator Cuff Syndrome: A Comparison
A study testing Remote Monitoring of Participant Progress and Well-being via Video Calls and Face-to-Face Clinic-based Monitoring of Participant Progress and Well-being in people with Rotator Cuff Syndrome, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Rotator Cuff Syndrome (RCS) often lead to shoulder pain and reduced function, creating a demand for alternative treatments. This study examines the effectiveness of remote assessments and tele-exercise compared to traditional in-person methods for treating these injuries. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- Remote Monitoring of Participant Progress and Well-being via Video Calls and Face-to-Face Clinic-based Monitoring of Participant Progress and Well-being
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2023to 24 Jun 2024
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a diagnosis of rotator cuff tendinosis, tendinitis, impingement, or partial muscle rupture confirmed by shoulder MRI,
- Not benefiting from conservative methods such as activity restriction, ice application and analgesics, being referred to physical therapy sessions,
- Having single-sided shoulder problem, possessing the ability to understand and perform prescribed exercises,
- Having the cognitive and psychological capacity to read and interpret brochures, being familiar to smartphones for accessing digital exercise materials,
- Having internet access.
Who cannot join
- Cognitive impairment,
- Bilateral rotator cuff syndrome,
- Total rupture of rotator cuff muscle,
- Previous fractures or surgeries on the same shoulder,
- Shoulder instability,
- Visual impairments,
Show all 12Show fewer
- Extremity amputations,
- Advanced cancer and complicated diabetes,
- Recent injections to the same shoulder within the last 6 months,
- Having received physical therapy or home exercise advice within the last 6 months,
- Lacking personal smartphones or internet access,
- Undergoing cancer treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Teleexercise and Remote Assessments in Rotator Cuff Syndrome: A Comparative Trial
Rotator Cuff Syndrome (RCS) often lead to shoulder pain and reduced function, creating a demand for alternative treatments. This study examines the effectiveness of remote assessments and tele-exercise compared to traditional in-person methods for treating these injuries. The telemedicine group will receive remote consultations and asynchronous exercise videos, while the control group will have face-to-face meetings and comprehensive information. Follow-up assessments will track exercise compliance for both groups. Additionally, a questionnaire will assess functionality, and pain levels will be evaluated using a pain scale, providing a comprehensive evaluation of treatment outcomes.
Read the detailed description
This study employs a randomized controlled clinical trial with a parallel design conducted at a hospital-based Physical Therapy and Rehabilitation Clinic. The study is planned to involve 76 voluntary participants.
Inclusion criteria for participants encompass the following: participants must be within the age range of 30 to 65, diagnosed with conditions such as rotator cuff tendinosis, tendinitis, impingement, or partial rupture, confirmed through shoulder MR imaging, have not experienced improvement through conservative methods (e.g., activity restriction, ice application, and analgesics), and must have been referred for physical therapy sessions.
Participants will be randomly assigned to two groups, with efforts to maintain balance in terms of age and gender distribution. Data collection methods include detailed documentation of participants' clinical diagnoses and demographic information (e.g., age, gender, education level, occupation, dominance of the affected side, and whether the occupation involves physical labor or heavy lifting).
Before the study commences, all participants will receive comprehensive explanations of the study's objectives, provide informed consent by signing consent forms, and share their contact information for communication purposes. Participants will be informed of their rights to discontinue treatment at any point and to reach out to the researcher with questions or concerns during the study.
Participants in the Exercise Group will have face-to-face assessments at the clinic on the first day. This includes completing the Quick- Disabilities of the Arm, Shoulder and Hand (Quick- DASH) questionnaire and the Numeric Visual Analog Scale (VAS) for pain assessment. They will receive information about their condition, a brochure containing a home exercise program, and an exercise diary to record exercise details. Follow-up assessments will occur on the 7th and 15th days at the clinic.
Participants in the Telemedicine Group will have a different approach. On the first day of the study, they will have video calls through FaceTime or WhatsApp. The Quick-DASH questionnaire and Numeric VAS scale will be administered and they will receive information about their condition. Subsequently, a pre-recorded video comprising the home exercise program, along with an exercise diary to record exercise details, will be sent to them via WhatsApp. Follow-up assessments will occur on the 7th and 15th days through video calls. Both groups will receive regular follow-up phone calls to collect their VAS scores at the 6th-month mark.
The Quick-DASH questionnaire assesses upper extremity function, including functionality, pain, symptoms, and quality of life. It consists of 11 questions, each scored on a scale. The Numeric VAS pain scale measures pain intensity on a scale of 0 to 10.
The exercise brochure includes exercise descriptions and visual demonstrations aimed at improving joint range of motion, adapted from programs provided by the American Academy of Orthopaedic Surgeons.
The exercise diary provided to participants consists of a table with three columns for each day, spanning 15 days in total. Each day is divided into three time slots: morning, noon, and evening. Participants will be instructed to mark the relevant box when they complete the exercises at the specified times, and if they do not perform the exercises during that particular time slot on a given day, they should leave the box empty.
This methodology aims to assess the impact of telemedicine methods on the treatment outcomes of RCS patients compared to traditional methods, as well as to improve patients' access to treatment and enhance the efficiency of healthcare resources.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- Remote Monitoring of Participant Progress and Well-being via Video Calls, Face-to-Face Clinic-based Monitoring of Participant Progress and Well-being
- Keywords
- rotator cuff syndrome, telemedicine, teleexercise, asynchronous video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring of Participant Progress and Well-being via Video CallsOther
Also called Delivery of Asynchronous Home Exercise Video Through WhatsApp, Monitoring Exercise Adherence Using Exercise Diaries, Evaluating Shoulder Function and Pain Using Questionnaire and Pain Scale After Home Exercise Program
Participants with Rotator Cuff Syndrome undergo remote evaluations via video calls with a physician. On the same day, they receive an asynchronous exercise brochure containing instructions for performing home exercises three times a day. They are also provided with an exercise diary to track their daily exercise sessions. Follow-up assessments and discussions about their condition take place remotely on video calls with the physician on the 7th and 15th days. During the final video call on the 15th day, participants are asked to submit their exercise diaries via WhatsApp for assessment of exercise adherence.
Face-to-Face Clinic-based Monitoring of Participant Progress and Well-beingOther
Also called Hand-Delivery of Home Exercise Brochure, Monitoring Exercise Adherence Using Exercise Diaries, Evaluating Shoulder Function and Pain Using Questionnaire and Pain Scale After Home Exercise Program
Participants with Rotator Cuff Syndrome undergo in-clinic evaluations by a physician, during which they receive an exercise brochure with instructions for performing home exercises three times a day. They are also given an exercise diary to track their daily exercise sessions. On the 7th and 15th days, participants return for follow-up assessments and discussions about their condition. During the final clinic visit, participants are requested to submit their exercise diaries for assessment of exercise adherence.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Group: Remote Assessments and Asynchronous Exercise Guidance | Experimental | For the Telemedicine Group, the study initiates with a video call from the physician on day one via FaceTime or WhatsApp. During these calls, patients will receive guidance and complete Quick-DASH questionnaire and numeric-VAS scale. On the same day, they will also receive an exercise video and an exercise diary via WhatsApp. Follow-up video calls on the 7th day will serve as reminders and allow patients to ask questions. The final video call, scheduled for the 15th day, will involve completing the same questionnaire and scale. After this last remote interaction, patients will send photos of their completed exercise logs to the physician via WhatsApp for adherence tracking. Receives: Other: Remote Monitoring of Participant Progress and Well-being via Video Calls |
| Control Group: In-Person Assessments in Clinic and Exercise Brochure | Active comparator | For the Control Group, the study begins with an in-person visit to the physician on day one. During this visit, patients will receive guidance, complete Quick-DASH questionnaire and numeric-VAS scale, and be provided with an exercise brochure. Additionally, patients will receive an exercise diary on the same day to record their exercise sessions. Follow-up visits to the physician's office at the hospital on the 7th day will serve as reminders and opportunities for patients to ask questions. On the 15th day, patients will revisit the hospital to complete the same questionnaire and scale. We will also assess the time spent and economic burden associated with hospital visits. Furthermore, exercise diaries will be collected for adherence tracking and progress evaluation. Receives: Other: Face-to-Face Clinic-based Monitoring of Participant Progress and Well-being |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels
Assessments of pain intensity using the numeric-Visual Analog Scale (VAS). The numeric-VAS typically ranges from 0 to 10, with 0 representing no pain or symptom and 10 representing the worst imaginable pain or symptom. The highest score on the VAS is 10, indicating the most severe pain or symptom.
Measured: At the first day, the 15th day and the 6th month of the study.
Functional Recovery
Evaluation of upper extremity function using the Quick-Disabilities of Arm, Shoulder, Hand (DASH) questionnaire. The Quick-DASH score can range from 0 to 100, with higher scores indicating more severe disability or symptoms. A score of 0 would mean no disability or symptoms, while a score of 100 would suggest the most severe disability or symptoms. Generally, a lower Quick-DASH score represents better functioning and less disability.
Measured: At the first day and the 15th day of the study.
Exercise Adherence
Monitoring and recording participants' adherence to the prescribed home exercise program through exercise diaries. This would involve tracking the frequency and consistency of exercise performance.
Measured: From the first day till the 15th day of the study (15 days time frame).
Secondary outcomes (2)
Patient Satisfaction with Likert Satisfaction Scale
Gathering feedback from participants on their satisfaction with the assigned treatment approach for shoulder pain using a Likert scale of satisfaction, where they rate their satisfaction level from 1 (Very Dissatisfied) to 5 (Very Satisfied).
Measured: From the first day till the 15th date of the study (15 days time frame).
Evaluating Travel Distance and Time for Control Group In-Person Hospital Visits
Assessing Travel Distance and Time for Control Group Hospital Visits: Participants will provide details of their single-day round-trip travel from home to the hospital and back, including kilometers traveled and minutes spent. This data will be used to calculate the economic burden and time commitment associated with in-person hospital visits.
Measured: Data will be collected on the first day of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start24 Nov 2023
- Primary completion19 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design: This study utilizes a randomized controlled parallel-design approach to evaluate the effectiveness of telemedicine methods in treating RCS compared to traditional in-person methods. Participants: The study will include 76 participants aged 40 to 60 years diagnosed with RCS, confirmed through shoulder MRI, and unresponsive to conservative treatments. They are randomly assigned to two groups. Intervention Group/Telemedicine Group: Remote assessments, video exercise program, and virtual follow-ups. Control Group: In-person assessments, exercise program, and follow-ups. Data Collection: Comprehensive documentation of clinical diagnoses and demographics, informed consent, and outcome measures (Quick-DASH and Numeric-VAS) are collected. Outcome Measures: The study assesses pain levels, functional recovery, and overall treatment outcomes. Analysis: Statistical analysis is conducted to compare treatment effectiveness between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selkin Yılmaz Muluk, Antalya Training and Research Hospital
- Investigators
- Selkin Yılmaz, Principal investigator, Antalya Ataturk Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194435
- Sponsor's protocol ID
- Antalya Ataturk State Hospital
- Acronym
- TFRCSAC
- Status last verified
- Jan 2025
- First submitted
- 30 Nov 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our plan is to share individual participant data collected during this study with qualified researchers and institutions for the purpose of promoting transparency and furthering scientific research.
Publications
Harms S, Kobusingye O. Factors that influence the use of rehabilitation services in an urban Ugandan hospital. Int J Rehabil Res. 2003 Mar;26(1):73-7. doi: 10.1097/00004356-200303000-00012.
PubMed 12601273Amorese AJ, Ryan AS. Home-Based Tele-Exercise in Musculoskeletal Conditions and Chronic Disease: A Literature Review. Front Rehabil Sci. 2022 Feb 24;3:811465. doi: 10.3389/fresc.2022.811465. eCollection 2022.
PubMed 36188988
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Teleexercise and Remote Assessments in Rotator Cuff Syndrome: A Comparative Trial
- ClinicalTrials.gov ID
- NCT06194435
- Acronym / sponsor ID
- TFRCSAC / Antalya Ataturk State Hospital
- Conditions
- Rotator Cuff Syndrome
- Keywords
- rotator cuff syndrome, telemedicine, teleexercise, asynchronous video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 8 Jan 2024 (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.
Rotator Cuff Syndrome (RCS) often lead to shoulder pain and reduced function, creating a demand for alternative treatments. This study examines the effectiveness of remote assessments and tele-exercise compared to traditional in-person methods for treating these injuries. The telemedicine group will receive remote consultations and asynchronous exercise videos, while the control group will have face-to-face meetings and comprehensive information. Follow-up assessments will track exercise compliance for both groups. Additionally, a questionnaire will assess functionality, and pain levels will be evaluated using a pain scale, providing a comprehensive evaluation of treatment outcomes.
Detailed description
This study employs a randomized controlled clinical trial with a parallel design conducted at a hospital-based Physical Therapy and Rehabilitation Clinic. The study is planned to involve 76 voluntary participants.
Inclusion criteria for participants encompass the following: participants must be within the age range of 30 to 65, diagnosed with conditions such as rotator cuff tendinosis, tendinitis, impingement, or partial rupture, confirmed through shoulder MR imaging, have not experienced improvement through conservative methods (e.g., activity restriction, ice application, and analgesics), and must have been referred for physical therapy sessions.
Participants will be randomly assigned to two groups, with efforts to maintain balance in terms of age and gender distribution. Data collection methods include detailed documentation of participants' clinical diagnoses and demographic information (e.g., age, gender, education level, occupation, dominance of the affected side, and whether the occupation involves physical labor or heavy lifting).
Before the study commences, all participants will receive comprehensive explanations of the study's objectives, provide informed consent by signing consent forms, and share their contact information for communication purposes. Participants will be informed of their rights to discontinue treatment at any point and to reach out to the researcher with questions or concerns during the study.
Participants in the Exercise Group will have face-to-face assessments at the clinic on the first day. This includes completing the Quick- Disabilities of the Arm, Shoulder and Hand (Quick- DASH) questionnaire and the Numeric Visual Analog Scale (VAS) for pain assessment. They will receive information about their condition, a brochure containing a home exercise program, and an exercise diary to record exercise details. Follow-up assessments will occur on the 7th and 15th days at the clinic.
Participants in the Telemedicine Group will have a different approach. On the first day of the study, they will have video calls through FaceTime or WhatsApp. The Quick-DASH questionnaire and Numeric VAS scale will be administered and they will receive information about their condition. Subsequently, a pre-recorded video comprising the home exercise program, along with an exercise diary to record exercise details, will be sent to them via WhatsApp. Follow-up assessments will occur on the 7th and 15th days through video calls. Both groups will receive regular follow-up phone calls to collect their VAS scores at the 6th-month mark.
The Quick-DASH questionnaire assesses upper extremity function, including functionality, pain, symptoms, and quality of life. It consists of 11 questions, each scored on a scale. The Numeric VAS pain scale measures pain intensity on a scale of 0 to 10.
The exercise brochure includes exercise descriptions and visual demonstrations aimed at improving joint range of motion, adapted from programs provided by the American Academy of Orthopaedic Surgeons.
The exercise diary provided to participants consists of a table with three columns for each day, spanning 15 days in total. Each day is divided into three time slots: morning, noon, and evening. Participants will be instructed to mark the relevant box when they complete the exercises at the specified times, and if they do not perform the exercises during that particular time slot on a given day, they should leave the box empty.
This methodology aims to assess the impact of telemedicine methods on the treatment outcomes of RCS patients compared to traditional methods, as well as to improve patients' access to treatment and enhance the efficiency of healthcare resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study Design: This study utilizes a randomized controlled parallel-design approach to evaluate the effectiveness of telemedicine methods in treating RCS compared to traditional in-person methods. Participants: The study will include 76 participants aged 40 to 60 years diagnosed with RCS, confirmed through shoulder MRI, and unresponsive to conservative treatments. They are randomly assigned to two groups. Intervention Group/Telemedicine Group: Remote assessments, video exercise program, and virtual follow-ups. Control Group: In-person assessments, exercise program, and follow-ups. Data Collection: Comprehensive documentation of clinical diagnoses and demographics, informed consent, and outcome measures (Quick-DASH and Numeric-VAS) are collected. Outcome Measures: The study assesses pain levels, functional recovery, and overall treatment outcomes. Analysis: Statistical analysis is conducted to compare treatment effectiveness between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Group: Remote Assessments and Asynchronous Exercise Guidance | Experimental | Other: Remote Monitoring of Participant Progress and Well-being via Video CallsFor the Telemedicine Group, the study initiates with a video call from the physician on day one via FaceTime or WhatsApp. During these calls, patients will receive guidance and complete Quick-DASH questionnaire and numeric-VAS scale. On the same day, they will also receive an exercise video and an exercise diary via WhatsApp. Follow-up video calls on the 7th day will serve as reminders and allow patients to ask questions. The final video call, scheduled for the 15th day, will involve completing the same questionnaire and scale. After this last remote interaction, patients will send photos of their completed exercise logs to the physician via WhatsApp for adherence tracking. |
| Control Group: In-Person Assessments in Clinic and Exercise Brochure | Active comparator | Other: Face-to-Face Clinic-based Monitoring of Participant Progress and Well-beingFor the Control Group, the study begins with an in-person visit to the physician on day one. During this visit, patients will receive guidance, complete Quick-DASH questionnaire and numeric-VAS scale, and be provided with an exercise brochure. Additionally, patients will receive an exercise diary on the same day to record their exercise sessions. Follow-up visits to the physician's office at the hospital on the 7th day will serve as reminders and opportunities for patients to ask questions. On the 15th day, patients will revisit the hospital to complete the same questionnaire and scale. We will also assess the time spent and economic burden associated with hospital visits. Furthermore, exercise diaries will be collected for adherence tracking and progress evaluation. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having a diagnosis of rotator cuff tendinosis, tendinitis, impingement, or partial muscle rupture confirmed by shoulder MRI,
- Not benefiting from conservative methods such as activity restriction, ice application and analgesics, being referred to physical therapy sessions,
- Having single-sided shoulder problem, possessing the ability to understand and perform prescribed exercises,
- Having the cognitive and psychological capacity to read and interpret brochures, being familiar to smartphones for accessing digital exercise materials,
- Having internet access.
Key exclusion criteria (12 listed)
- Cognitive impairment,
- Bilateral rotator cuff syndrome,
- Total rupture of rotator cuff muscle,
- Previous fractures or surgeries on the same shoulder,
- Shoulder instability,
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 |
|---|---|---|
| Remote Monitoring of Participant Progress and Well-being via Video CallsAlso: Delivery of Asynchronous Home Exercise Video Through WhatsApp, Monitoring Exercise Adherence Using Exercise Diaries, Evaluating Shoulder Function and Pain Using Questionnaire and Pain Scale After Home Exercise ProgramParticipants with Rotator Cuff Syndrome undergo remote evaluations via video calls with a physician. On the same day, they receive an asynchronous exercise brochure containing instructions for performing home exercises three times a day. They are also provided with an exercise diary to track their daily exercise sessions. Follow-up assessments and discussions about their condition take place remotely on video calls with the physician on the 7th and 15th days. During the final video call on the 15th day, participants are asked to submit their exercise diaries via WhatsApp for assessment of exercise adherence. | Other | Telemedicine Group: Remote Assessments and Asynchronous Exercise Guidance |
| Face-to-Face Clinic-based Monitoring of Participant Progress and Well-beingAlso: Hand-Delivery of Home Exercise Brochure, Monitoring Exercise Adherence Using Exercise Diaries, Evaluating Shoulder Function and Pain Using Questionnaire and Pain Scale After Home Exercise ProgramParticipants with Rotator Cuff Syndrome undergo in-clinic evaluations by a physician, during which they receive an exercise brochure with instructions for performing home exercises three times a day. They are also given an exercise diary to track their daily exercise sessions. On the 7th and 15th days, participants return for follow-up assessments and discussions about their condition. During the final clinic visit, participants are requested to submit their exercise diaries for assessment of exercise adherence. | Other | Control Group: In-Person Assessments in Clinic and Exercise Brochure |
Primary outcome
Pain Levels
Time frame: At the first day, the 15th day and the 6th month of the study.
Assessments of pain intensity using the numeric-Visual Analog Scale (VAS). The numeric-VAS typically ranges from 0 to 10, with 0 representing no pain or symptom and 10 representing the worst imaginable pain or symptom. The highest score on the VAS is 10, indicating the most severe pain or symptom.
Functional Recovery
Time frame: At the first day and the 15th day of the study.
Evaluation of upper extremity function using the Quick-Disabilities of Arm, Shoulder, Hand (DASH) questionnaire. The Quick-DASH score can range from 0 to 100, with higher scores indicating more severe disability or symptoms. A score of 0 would mean no disability or symptoms, while a score of 100 would suggest the most severe disability or symptoms. Generally, a lower Quick-DASH score represents better functioning and less disability.
Exercise Adherence
Time frame: From the first day till the 15th day of the study (15 days time frame).
Monitoring and recording participants' adherence to the prescribed home exercise program through exercise diaries. This would involve tracking the frequency and consistency of exercise performance.
2 secondary outcomes
Patient Satisfaction with Likert Satisfaction Scale
Time frame: From the first day till the 15th date of the study (15 days time frame).
Evaluating Travel Distance and Time for Control Group In-Person Hospital Visits
Time frame: Data will be collected on the first day of the study.
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 23 Jan 2025.
- Background: PubMed 12601273Harms S, Kobusingye O. Factors that influence the use of rehabilitation services in an urban Ugandan hospital. Int J Rehabil Res. 2003 Mar;26(1):73-7. doi: 10.1097/00004356-200303000-00012.
- Background: PubMed 36188988Amorese AJ, Ryan AS. Home-Based Tele-Exercise in Musculoskeletal Conditions and Chronic Disease: A Literature Review. Front Rehabil Sci. 2022 Feb 24;3:811465. doi: 10.3389/fresc.2022.811465. eCollection 2022.
- 'Rotator Cuff and Shoulder Conditioning Program' of American Academy of Orthopaedic Surgeons.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Our plan is to share individual participant data collected during this study with qualified researchers and institutions for the purpose of promoting transparency and furthering scientific research.
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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.
Selkin Yılmaz principal investigator
Antalya Ataturk Devlet Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring of Participant Progress and Well-being via Video Calls and Face-to-Face Clinic-based Monitoring of Participant Progress and Well-being in people with Rotator Cuff Syndrome, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 12 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 23 Jan 2025. 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 Turkey (Türkiye). 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?
Pain Levels (time frame: At the first day, the 15th day and the 6th month of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194435, which also lists 2 linked publications.
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 23 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.