Rotator Cuff TearNCT07555704
Remote App-based Rehabilitation After Rotator Cuff Repair
A study testing Telerehabilitation and Conventional home exercise program in people with Rotator Cuff Tear and Telemedecine, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear, Telemedecine, Rotator Cuff Injuries
- What is being tested?
- Telerehabilitation and Conventional home exercise program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Demographics: Individuals aged 18 years or older.
- Diagnosis: Confirmed symptomatic rotator cuff tear requiring surgical intervention, specifically involving:
- Clinical Presentation: Persistent shoulder pain and functional deficits (e.g., positive impingement signs or weakness in abduction/external rotation) consistent with rotator cuff pathology.
- Radiological Confirmation: Imaging evidence (MRI or high-resolution ultrasound) of a full-thickness supraspinatus and/or infraspinatus tendon tear.
- Tear Characteristics: Small-to-medium-sized tears (maximum diameter < 5 cm) categorized as reparable by the attending surgeon.
- Surgical Procedure: Patients undergoing primary arthroscopic rotator cuff repair (ARCR) utilizing a standardized double-row suture bridge technique.
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- Rehabilitation Adherence: Commitment to follow the standardized postoperative rehabilitation protocol as prescribed by the study.
- Cognitive and Functional Capacity:
- Absence of cognitive impairment, with the ability to comprehend and execute complex exercise instructions.
- Proficiency in digital literacy, including the regular use of an internet-enabled electronic device (smartphone, tablet, or computer) capable of video-based communication and data transmission.
- Documentation and Consent:
- Availability of comprehensive medical records, including pre- and postoperative clinical and radiological data.
- Provision of written informed consent by the patient or a legal representative prior to enrollment
Who cannot join
- Pre-existing or concomitant upper extremity dysfunction unrelated to the rotator cuff tear, including cervical disc herniation, cerebrovascular accident (stroke), traumatic brain injury, cervical spinal cord injury, rheumatoid arthritis with shoulder involvement, or brachial plexus injury.
- Complex or irreparable rotator cuff tears, defined as large or massive tears (> 5 cm), high-grade fatty infiltration of the rotator cuff muscles (Goutallier grade ≥ 3), or inability to achieve secure tendon repair using sutures during arthroscopic surgery.
- Postoperative complications that significantly interfere with rehabilitation, such as surgical site infection, nerve injury with paralysis, or severe deltoid muscle damage.
- Severe comorbidities that may substantially affect the rehabilitation process or patient safety, including acute coronary syndrome, recent stroke, uncontrolled diabetes mellitus, or other debilitating systemic diseases.
- Inability or unwillingness to comply with the study protocol, including failure to attend scheduled follow-up assessments or voluntary withdrawal from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Hanoi Medical University
Hanoi, 100000
Tu H Nguyen, Prof, 84-2438523798, dhyhn@hmu.edu.vn
About this study
Official title: Effectiveness of a Combined Intervention Incorporating a Remote Rehabilitation Application for Patients After Arthroscopic Repair of Rotator Cuff Tears: A Randomized Controlled Trial
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.
Read the detailed description
Shoulder pain is the third most common medical condition seen in primary care settings, with 65-70% of patients experiencing rotator cuff injuries. Therefore, rotator cuff injuries significantly impact patients' mobility and place a considerable burden on the healthcare system and employers. The majority of patients are treated conservatively; however, approximately 40% of patients with rotator cuff tears, in which the primary injury is a tear of the supraspinatus and infraspinatus tendons, experience persistent pain and require surgical intervention. Effective rehabilitation programs can address disability and functional impairments in patients, such as joint range of motion, muscle strength, and persistent pain.
However, not all patients who have undergone rotator cuff surgery have full access to in-person rehabilitation programs due to geographical, financial, and awareness barriers, or other objective factors such as epidemics. Furthermore, many patients lack the skills and knowledge to perform guided exercises at home, or receive inadequate guidance. In this context, tele-rehabilitation is considered a potential solution to mitigate the drawbacks of in-person and self-training methods.
This study was designed to address gaps in practical implementation by evaluating whether the addition of a culturally adapted smartphone-based telerehabilitation application to standard postoperative physiotherapy could improve clinical outcomes compared to using standard physiotherapy alone.
The primary objective was to determine the effectiveness of combined telerehabilitation intervention on shoulder function, as measured by changes in Constant-Murley and Quick DASH scores 24 weeks after arthroscopic repair of rotator cuff tendon injuries.
Secondary objectives include assessing the impact of the intervention on active range of motion, isotonic shoulder strength, pain intensity, specific functional capacity of the patient, psychological factors (movement anxiety and rehabilitation confidence), treatment adherence, health-related quality of life, return to work status, direct non-medical costs, and caregiver time burden. The study will also assess safety through the rate of rotator cuff re-tear after 24 weeks and investigate factors related to treatment response. The study employs a comprehensive biopsychosocial assessment. Beyond physical recovery, we evaluate the interplay between psychological barriers (kinesiophobia via TSK-11), psychological assets (self-efficacy via SER), and resulting clinical behavior (adherence via EARS) to provide a holistic view of the patient's rehabilitation journey.
This is a randomized, controlled, single-center clinical trial conducted at Viet Duc Friendship Hospital in Hanoi, Vietnam. A total of 102 patients eligible for arthroscopic rotator cuff repair are expected to be recruited and randomized in a 1:1 ratio into either the intervention or control group using a computer-generated block randomization. During the first 6 weeks post-surgery, all patients received direct instruction in physical therapy with a total of 6-8 treatment sessions. After 6 weeks, patients were divided into two groups.
Participants in the intervention group received the hospital's standard surgical physiotherapy protocol along with access to a dedicated smartphone application. This application provided daily exercise instruction videos tailored to each rehabilitation phase, automatic reminders, real-time compliance monitoring, and asynchronous communication with the physiotherapist for remote feedback and progress tracking.
Participants in the control group received only the hospital's standard surgical physiotherapy protocol and were explicitly instructed not to use any additional rehabilitation applications or online exercise programs throughout the 24-week study period.
All participants followed the same standard three-phase rehabilitation protocol developed by the hospital's Department of Rehabilitation based on the Vietnamese Ministry of Health guidelines and Massachusetts General Hospital:
Phase 1 (weeks 0-6): Assisted passive protection and movement. Phase 2 (weeks 6-12): Active movement, starting with light resistance. Phase 3 (weeks 12-24): Gradual strengthening and rehabilitation. Assessment of outcomes was planned at baseline (pre-surgery), 6 weeks, 12 weeks, and 24 weeks post-surgery. The primary endpoint was the change in Constant-Murley and Quick DASH scores from baseline to 24 weeks. Secondary criteria include active range of motion measured by an angle measuring device, isotonic shoulder strength measured by a handheld dynamometer (forward flexion, abduction, external rotation, and internal rotation), visual analog scale (VAS) for pain at rest and during activity, Patient-Specific Functional Scale (PSFS), Tampa Scale of Movement Aversion (TSK-11), Self-Effect Scale of Rehabilitation (SER), Exercise Compliance Scale (EARS), EQ-5D-5L for quality of life, time and extent of return to work, total direct non-medical costs, and number of lost workdays for caregivers. Rotator cuff tendon integrity will be assessed after 24 weeks using ultrasound or MRI.
Data will be collected using a standard electronic case report form. When participants are unable to attend in-person consultations, data collection will be conducted through structured telephone interviews or home visits by trained research staff, with the methodology clearly documented for each assessment to allow for sensitivity analysis.
The study will be conducted in full compliance with the Helsinki Declaration and the ICH Good Clinical Practice guidelines. This study has been approved by the Medical Ethics Committee of Hanoi Medical University. All participants will provide written informed consent before enrollment.
- Conditions
- Rotator Cuff Tear, Telemedecine, Rotator Cuff Injuries
- Being tested
- Telerehabilitation, Conventional home exercise program
- Keywords
- Rotator Cuff Tears, Rotator Cuff Injuries, Telerehabilitation, Mobile Application, Digital Health, Arthroscopic Rotator Cuff Repair
- 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.
TelerehabilitationProcedure or surgery
Also called App-based home exercise program, Mobile Health rehabilitation
High-quality instructional videos on each stage of the personalized exercise program, with AI-assisted observation and correction for post-surgical rotator cuff tendon repair.
Daily automated reminders to keep patients informed of their exercise schedule. Interactive digital log to record completed sessions and pain levels. Asynchronous communication with a physical therapist for guidance and program adjustments.
The program is designed to enhance treatment adherence and track patient progress in real time throughout the 6-month rehabilitation period.
Conventional home exercise programProcedure or surgery
The control intervention consists of a conventional home-based exercise program. Patients will receive:
During the first 6 weeks, patients will be trained directly by a physical therapist.
A printed brochure containing static illustrations and written step-by-step instructions for the post-operative rotator cuff rehabilitation protocol.
Standard verbal education from a physiotherapist during the directly training session.
Having digital mobile reminders one time per week; patients are expected to manage their exercise frequency independently.
Communication with the medical team is limited to scheduled follow-up visits at the hospital and when called by mobile.
This group serves as the active comparator to evaluate the added value of the digital mobile application intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients in this group will perform a structured home-based rehabilitation program guided by a mobile application (RehaX, RealPT). The app provides instructional videos for exercises, daily reminders, and a digital diary to track progress. Additionally, patients can communicate with physiotherapists through a built-in messaging system for guidance and adjustments to their exercise protocol. For the first six weeks, patients receive direct instruction from a physiotherapists. After six weeks, patients receive instruction guided by the mobile application. Receives: Procedure: Telerehabilitation |
| Control Group | Active comparator | Patients in this group will follow a standard home rehabilitation program. They will receive a printed booklet with still images and written instructions on the same exercise regimen as the experimental group. For the first six weeks, patients will receive direct instruction from a rehabilitation technician. After six weeks, patients will exercise independently at home. No digital monitoring devices or mobile applications will be provided; patients will monitor their health status with therapists during regular clinic visits. Receives: Procedure: Conventional home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant-Murley score from baseline to 24 weeks post-surgery
The Constant-Murley Shoulder Score is a validated shoulder-specific outcome measure that evaluates pain, activities of daily living, range of motion, and strength (total score 0-100, higher scores indicate better function).
The primary outcome is the mean change in Constant-Murley score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
Measured: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
Change in Quick DASH score from baseline to 24 weeks after arthroscopic rotator cuff repair
The Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) is a patient-reported questionnaire assessing upper extremity physical function and symptoms (score 0-100, lower scores indicate better function).
The primary outcome is the mean change in Quick DASH score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
Measured: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
Secondary outcomes (11)
Change in active range of motion of the operated shoulder from baseline to 24 weeks
Active range of motion (forward flexion, abduction, external rotation, and internal rotation) measured with a goniometer. Change from pre-operative baseline to 24 weeks will be compared between groups.
Measured: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively
Change in isometric shoulder strength from baseline to 24 weeks
Isometric muscle strength of the operated shoulder (forward flexion, abduction, external rotation, and internal rotation) measured with a handheld dynamometer (kg). The mean of three trials is recorded. Change from baseline to 24 weeks will be compared between groups.
Measured: Assessed at baseline (pre-operative), 12 weeks, and 24 weeks post-operatively
Change in pain intensity (VAS) at rest and during activity from baseline to 24 weeks
Pain intensity measured using the Visual Analog Scale (VAS 0-10) at rest and during activity. Change from pre-operative baseline to 24 weeks will be compared between the intervention and control groups.
Measured: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively
Change in Tampa Scale for kinesiophobia (TSK-11) from baseline to 24 weeks
The TSK-11 is a patient-reported questionnaire used to assess fear of movement or injury. It consists of 11 items, each scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 11 to 44. A higher total score indicates a higher degree of kinesiophobia (greater fear of movement).
Measured: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively.
Rotator cuff re-tear rate at 24 weeks post-operatively
Incidence of rotator cuff re-tear confirmed by ultrasound or MRI at 24 weeks after surgery. The proportion of re-tear will be compared between the tele-rehabilitation group and the control group.
Measured: At 24 weeks after arthroscopic rotator cuff repair
Time and level of return to work at 24 weeks
Time (weeks) to return to work and level of return to work (not returned / part-time / full-time same job / full-time heavier duty). These will be compared between groups.
Measured: Assessed at 12 weeks and 24 weeks post-operatively
Change in Health-related quality of life (EQ-5D-5L) at 24 weeks
Health-related quality of life is assessed using the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire. It consists of two parts: the EQ-5D descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from 1 (no problems) to 5 (extreme problems/unable to). These levels are converted into a single index score (typically ranging from 0 to 1, where 1 indicates perfect health). The EQ VAS records the patient's self-rated health on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine)
Measured: Assessed at 24 weeks post-operatively
Change in Self-Efficacy for Rehabilitation Scale (SER) at 24 weeks
The SER scale assesses a patient's belief in their ability to perform rehabilitation tasks. It consists of 12 items, each scored from 0 (not confident at all) to 10 (completely confident). The total score ranges from 0 to 120. Higher scores indicate higher self-efficacy and greater confidence in the patient's ability to successfully engage in the rehabilitation process
Measured: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively
Change from baseline in Exercise Adherence Rating Scale (EARS) at 24 weeks.
The EARS measures the level of adherence to prescribed home exercise programs. It consists of 6 items focusing on adherence behavior. Each item is scored on a 4-point Likert scale from 0 (strongly disagree) to 3 (strongly agree). The total score for this section ranges from 0 to 18. Higher scores represent better adherence to the exercise protocol.
Measured: 6 weeks, 12 weeks, 24 weeks post-operatively
Total Direct Non-Medical Costs at 24 weeks.
This measure assesses the economic burden of the treatment process. It includes the total accumulated expenses for transportation, meals, and lodging incurred by the patient and their family during hospital visits and rehabilitation sessions over the 24-week period. Data are collected via a structured cost questionnaire. Results are expressed as the total amount in Vietnam Dong (VND)
Measured: 24 weeks (accumulated from baseline)
Caregiver Productivity Loss at 24 weeks
Caregiver burden is measured by the total number of work-days lost by the primary caregiver due to assisting the patient with hospital visits, rehabilitation sessions, or home care activities related to the recovery process. This is recorded as a cumulative number of days over the 24-week study period
Measured: 24 weeks (accumulated from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- A randomized, two-arm, parallel-group controlled trial. Participants are randomly assigned to either the experimental group (using a remote rehabilitation mobile application) or the control group (receiving conventional paper-based exercise instructions) with a 1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pham Dinh Phuong, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555704
- Sponsor's protocol ID
- 01250212
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780.
PubMed 33935152Agostini F, de Sire A, Finamore N, Savina A, Sveva V, Fisicaro A, Fricano A, Longo UG, Ammendolia A, Bernetti A, Mangone M, Paoloni M. Rehabilitative Good Practices in the Treatment of Patients with Muscle Injuries. J Clin Med. 2025 Jul 29;14(15):5355. doi: 10.3390/jcm14155355.
PubMed 40806982Shim GY, Kim EH, Baek YJ, Chang WK, Kim BR, Oh JH, Lee JI, Hwang JH, Lim JY. A randomized controlled trial of postoperative rehabilitation using digital healthcare system after rotator cuff repair. NPJ Digit Med. 2023 May 23;6(1):95. doi: 10.1038/s41746-023-00842-7.
PubMed 37221303Zhang B, Fang Z, Nian K, Sun B, Ji B. The effects of telemedicine on Rotator cuff-related shoulder function and pain symptoms: a meta-analysis of randomized clinical trials. J Orthop Surg Res. 2024 Aug 14;19(1):478. doi: 10.1186/s13018-024-04986-4.
PubMed 39143625Phuphanich ME, Sinha KR, Truong M, Pham QG. Telemedicine for Musculoskeletal Rehabilitation and Orthopedic Postoperative Rehabilitation. Phys Med Rehabil Clin N Am. 2021 May;32(2):319-353. doi: 10.1016/j.pmr.2020.12.004. Epub 2021 Feb 15.
PubMed 33814061Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal Physical Therapy During the COVID-19 Pandemic: Is Telerehabilitation the Answer? Phys Ther. 2020 Aug 12;100(8):1260-1264. doi: 10.1093/ptj/pzaa093. No abstract available.
PubMed 32386218Shnitzer H, Chan J, Yau T, McIntyre M, Andreoli A, Kua A, Bayley M, Leochico CF, Guo M, Munce S. The Safety of Telerehabilitation: Systematic Review. JMIR Rehabil Assist Technol. 2025 Jul 9;12:e68681. doi: 10.2196/68681.
PubMed 40632682Quigley A, Johnson H, McArthur C. Transforming the Provision of Physiotherapy in the Time of COVID-19: A Call to Action for Telerehabilitation. Physiother Can. 2021 Winter;73(1):1-2. doi: 10.3138/ptc-2020-0031-gee.
PubMed 35110818Rogante M, Grigioni M, Cordella D, Giacomozzi C. Ten years of telerehabilitation: A literature overview of technologies and clinical applications. NeuroRehabilitation. 2010;27(4):287-304. doi: 10.3233/NRE-2010-0612.
PubMed 21160118Peretti A, Amenta F, Tayebati SK, Nittari G, Mahdi SS. Telerehabilitation: Review of the State-of-the-Art and Areas of Application. JMIR Rehabil Assist Technol. 2017 Jul 21;4(2):e7. doi: 10.2196/rehab.7511.
PubMed 28733271Ezell DJ, Malcarney HL. Rotator cuff repair rehabilitation considerations and respective guidelines: a narrative review. JSES Rev Rep Tech. 2021 May 13;1(3):179-185. doi: 10.1016/j.xrrt.2021.04.009. eCollection 2021 Aug.
PubMed 37588949Lee J, Griepp DW, Burgess CJ, Petrone B, Bitterman AD, Cohn RM. The AAOS 2019 Clinical Practice Guidelines for the Management of Rotator Cuff Injuries Are Unbiased and Incorporate a Diverse Body of Literature. Arthrosc Sports Med Rehabil. 2022 Mar 1;4(2):e559-e565. doi: 10.1016/j.asmr.2021.11.017. eCollection 2022 Apr.
PubMed 35494298Peltz CD, Sarver JJ, Dourte LM, Wurgler-Hauri CC, Williams GR, Soslowsky LJ. Exercise following a short immobilization period is detrimental to tendon properties and joint mechanics in a rat rotator cuff injury model. J Orthop Res. 2010 Jul;28(7):841-5. doi: 10.1002/jor.21059.
PubMed 20058271Lv S, Wang Q, Ni Q, Qi C, Ma Y, Li S, Xu Y. Progress of Muscle Chain Theory in Shoulder Pain Rehabilitation: Potential Ideas for Pulmonary Rehabilitation. Evid Based Complement Alternat Med. 2022 Sep 6;2022:2537957. doi: 10.1155/2022/2537957. eCollection 2022.
PubMed 36110187
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Intervention Incorporating a Remote Rehabilitation Application for Patients After Arthroscopic Repair of Rotator Cuff Tears: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07555704
- Acronym / sponsor ID
- 01250212
- Conditions
- Rotator Cuff Tear, Telemedecine, Rotator Cuff Injuries
- Keywords
- Rotator Cuff Tears, Rotator Cuff Injuries, Telerehabilitation, Mobile Application, Digital Health, Arthroscopic Rotator Cuff Repair
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Apr 2026 (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.
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.
Detailed description
Shoulder pain is the third most common medical condition seen in primary care settings, with 65-70% of patients experiencing rotator cuff injuries. Therefore, rotator cuff injuries significantly impact patients' mobility and place a considerable burden on the healthcare system and employers. The majority of patients are treated conservatively; however, approximately 40% of patients with rotator cuff tears, in which the primary injury is a tear of the supraspinatus and infraspinatus tendons, experience persistent pain and require surgical intervention. Effective rehabilitation programs can address disability and functional impairments in patients, such as joint range of motion, muscle strength, and persistent pain.
However, not all patients who have undergone rotator cuff surgery have full access to in-person rehabilitation programs due to geographical, financial, and awareness barriers, or other objective factors such as epidemics. Furthermore, many patients lack the skills and knowledge to perform guided exercises at home, or receive inadequate guidance. In this context, tele-rehabilitation is considered a potential solution to mitigate the drawbacks of in-person and self-training methods.
This study was designed to address gaps in practical implementation by evaluating whether the addition of a culturally adapted smartphone-based telerehabilitation application to standard postoperative physiotherapy could improve clinical outcomes compared to using standard physiotherapy alone.
The primary objective was to determine the effectiveness of combined telerehabilitation intervention on shoulder function, as measured by changes in Constant-Murley and Quick DASH scores 24 weeks after arthroscopic repair of rotator cuff tendon injuries.
Secondary objectives include assessing the impact of the intervention on active range of motion, isotonic shoulder strength, pain intensity, specific functional capacity of the patient, psychological factors (movement anxiety and rehabilitation confidence), treatment adherence, health-related quality of life, return to work status, direct non-medical costs, and caregiver time burden. The study will also assess safety through the rate of rotator cuff re-tear after 24 weeks and investigate factors related to treatment response. The study employs a comprehensive biopsychosocial assessment. Beyond physical recovery, we evaluate the interplay between psychological barriers (kinesiophobia via TSK-11), psychological assets (self-efficacy via SER), and resulting clinical behavior (adherence via EARS) to provide a holistic view of the patient's rehabilitation journey.
This is a randomized, controlled, single-center clinical trial conducted at Viet Duc Friendship Hospital in Hanoi, Vietnam. A total of 102 patients eligible for arthroscopic rotator cuff repair are expected to be recruited and randomized in a 1:1 ratio into either the intervention or control group using a computer-generated block randomization. During the first 6 weeks post-surgery, all patients received direct instruction in physical therapy with a total of 6-8 treatment sessions. After 6 weeks, patients were divided into two groups.
Participants in the intervention group received the hospital's standard surgical physiotherapy protocol along with access to a dedicated smartphone application. This application provided daily exercise instruction videos tailored to each rehabilitation phase, automatic reminders, real-time compliance monitoring, and asynchronous communication with the physiotherapist for remote feedback and progress tracking.
Participants in the control group received only the hospital's standard surgical physiotherapy protocol and were explicitly instructed not to use any additional rehabilitation applications or online exercise programs throughout the 24-week study period.
All participants followed the same standard three-phase rehabilitation protocol developed by the hospital's Department of Rehabilitation based on the Vietnamese Ministry of Health guidelines and Massachusetts General Hospital:
Phase 1 (weeks 0-6): Assisted passive protection and movement. Phase 2 (weeks 6-12): Active movement, starting with light resistance. Phase 3 (weeks 12-24): Gradual strengthening and rehabilitation. Assessment of outcomes was planned at baseline (pre-surgery), 6 weeks, 12 weeks, and 24 weeks post-surgery. The primary endpoint was the change in Constant-Murley and Quick DASH scores from baseline to 24 weeks. Secondary criteria include active range of motion measured by an angle measuring device, isotonic shoulder strength measured by a handheld dynamometer (forward flexion, abduction, external rotation, and internal rotation), visual analog scale (VAS) for pain at rest and during activity, Patient-Specific Functional Scale (PSFS), Tampa Scale of Movement Aversion (TSK-11), Self-Effect Scale of Rehabilitation (SER), Exercise Compliance Scale (EARS), EQ-5D-5L for quality of life, time and extent of return to work, total direct non-medical costs, and number of lost workdays for caregivers. Rotator cuff tendon integrity will be assessed after 24 weeks using ultrasound or MRI.
Data will be collected using a standard electronic case report form. When participants are unable to attend in-person consultations, data collection will be conducted through structured telephone interviews or home visits by trained research staff, with the methodology clearly documented for each assessment to allow for sensitivity analysis.
The study will be conducted in full compliance with the Helsinki Declaration and the ICH Good Clinical Practice guidelines. This study has been approved by the Medical Ethics Committee of Hanoi Medical University. All participants will provide written informed consent before enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, two-arm, parallel-group controlled trial. Participants are randomly assigned to either the experimental group (using a remote rehabilitation mobile application) or the control group (receiving conventional paper-based exercise instructions) with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: TelerehabilitationPatients in this group will perform a structured home-based rehabilitation program guided by a mobile application (RehaX, RealPT). The app provides instructional videos for exercises, daily reminders, and a digital diary to track progress. Additionally, patients can communicate with physiotherapists through a built-in messaging system for guidance and adjustments to their exercise protocol. For the first six weeks, patients receive direct instruction from a physiotherapists. After six weeks, patients receive instruction guided by the mobile application. |
| Control Group | Active comparator | Procedure: Conventional home exercise programPatients in this group will follow a standard home rehabilitation program. They will receive a printed booklet with still images and written instructions on the same exercise regimen as the experimental group. For the first six weeks, patients will receive direct instruction from a rehabilitation technician. After six weeks, patients will exercise independently at home. No digital monitoring devices or mobile applications will be provided; patients will monitor their health status with therapists during regular clinic visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Demographics: Individuals aged 18 years or older.
- Diagnosis: Confirmed symptomatic rotator cuff tear requiring surgical intervention, specifically involving:
- Surgical Procedure: Patients undergoing primary arthroscopic rotator cuff repair (ARCR) utilizing a standardized double-row suture bridge technique.
- Rehabilitation Adherence: Commitment to follow the standardized postoperative rehabilitation protocol as prescribed by the study.
- Cognitive and Functional Capacity:
Key exclusion criteria (5 listed)
- Pre-existing or concomitant upper extremity dysfunction unrelated to the rotator cuff tear, including cervical disc herniation, cerebrovascular accident (stroke), traumatic brain injury, cervical spinal cord injury, rheumatoid arthritis with shoulder involvement, or brachial plexus injury.
- Complex or irreparable rotator cuff tears, defined as large or massive tears (> 5 cm), high-grade fatty infiltration of the rotator cuff muscles (Goutallier grade ≥ 3), or inability to achieve secure tendon repair using sutures during arthroscopic surgery.
- Postoperative complications that significantly interfere with rehabilitation, such as surgical site infection, nerve injury with paralysis, or severe deltoid muscle damage.
- Severe comorbidities that may substantially affect the rehabilitation process or patient safety, including acute coronary syndrome, recent stroke, uncontrolled diabetes mellitus, or other debilitating systemic diseases.
- Inability or unwillingness to comply with the study protocol, including failure to attend scheduled follow-up assessments or voluntary withdrawal from the study.
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 |
|---|---|---|
| TelerehabilitationAlso: App-based home exercise program, Mobile Health rehabilitationHigh-quality instructional videos on each stage of the personalized exercise program, with AI-assisted observation and correction for post-surgical rotator cuff tendon repair. Daily automated reminders to keep patients informed of their exercise schedule. Interactive digital log to record completed sessions and pain levels. Asynchronous communication with a physical therapist for guidance and program adjustments. The program is designed to enhance treatment adherence and track patient progress in real time throughout the 6-month rehabilitation period. | Procedure or surgery | Experimental Group |
| Conventional home exercise programThe control intervention consists of a conventional home-based exercise program. Patients will receive: During the first 6 weeks, patients will be trained directly by a physical therapist. A printed brochure containing static illustrations and written step-by-step instructions for the post-operative rotator cuff rehabilitation protocol. Standard verbal education from a physiotherapist during the directly training session. Having digital mobile reminders one time per week; patients are expected to manage their exercise frequency independently. Communication with the medical team is limited to scheduled follow-up visits at the hospital and when called by mobile. This group serves as the active comparator to evaluate the added value of the digital mobile application intervention. | Procedure or surgery | Control Group |
Primary outcome
Change in Constant-Murley score from baseline to 24 weeks post-surgery
Time frame: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
The Constant-Murley Shoulder Score is a validated shoulder-specific outcome measure that evaluates pain, activities of daily living, range of motion, and strength (total score 0-100, higher scores indicate better function). The primary outcome is the mean change in Constant-Murley score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
Change in Quick DASH score from baseline to 24 weeks after arthroscopic rotator cuff repair
Time frame: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
The Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) is a patient-reported questionnaire assessing upper extremity physical function and symptoms (score 0-100, lower scores indicate better function). The primary outcome is the mean change in Quick DASH score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
11 secondary outcomes
Change in active range of motion of the operated shoulder from baseline to 24 weeks
Time frame: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively
Change in isometric shoulder strength from baseline to 24 weeks
Time frame: Assessed at baseline (pre-operative), 12 weeks, and 24 weeks post-operatively
Change in pain intensity (VAS) at rest and during activity from baseline to 24 weeks
Time frame: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively
Change in Tampa Scale for kinesiophobia (TSK-11) from baseline to 24 weeks
Time frame: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively.
Rotator cuff re-tear rate at 24 weeks post-operatively
Time frame: At 24 weeks after arthroscopic rotator cuff repair
Time and level of return to work at 24 weeks
Time frame: Assessed at 12 weeks and 24 weeks post-operatively
Change in Health-related quality of life (EQ-5D-5L) at 24 weeks
Time frame: Assessed at 24 weeks post-operatively
Change in Self-Efficacy for Rehabilitation Scale (SER) at 24 weeks
Time frame: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively
Change from baseline in Exercise Adherence Rating Scale (EARS) at 24 weeks.
Time frame: 6 weeks, 12 weeks, 24 weeks post-operatively
Total Direct Non-Medical Costs at 24 weeks.
Time frame: 24 weeks (accumulated from baseline)
Caregiver Productivity Loss at 24 weeks
Time frame: 24 weeks (accumulated from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Results publication: PubMed 33935152Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780.
- Results publication: PubMed 40806982Agostini F, de Sire A, Finamore N, Savina A, Sveva V, Fisicaro A, Fricano A, Longo UG, Ammendolia A, Bernetti A, Mangone M, Paoloni M. Rehabilitative Good Practices in the Treatment of Patients with Muscle Injuries. J Clin Med. 2025 Jul 29;14(15):5355. doi: 10.3390/jcm14155355.
- Results publication: PubMed 37221303Shim GY, Kim EH, Baek YJ, Chang WK, Kim BR, Oh JH, Lee JI, Hwang JH, Lim JY. A randomized controlled trial of postoperative rehabilitation using digital healthcare system after rotator cuff repair. NPJ Digit Med. 2023 May 23;6(1):95. doi: 10.1038/s41746-023-00842-7.
- Results publication: PubMed 39143625Zhang B, Fang Z, Nian K, Sun B, Ji B. The effects of telemedicine on Rotator cuff-related shoulder function and pain symptoms: a meta-analysis of randomized clinical trials. J Orthop Surg Res. 2024 Aug 14;19(1):478. doi: 10.1186/s13018-024-04986-4.
- Results publication: PubMed 33814061Phuphanich ME, Sinha KR, Truong M, Pham QG. Telemedicine for Musculoskeletal Rehabilitation and Orthopedic Postoperative Rehabilitation. Phys Med Rehabil Clin N Am. 2021 May;32(2):319-353. doi: 10.1016/j.pmr.2020.12.004. Epub 2021 Feb 15.
- Results publication: PubMed 32386218Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal Physical Therapy During the COVID-19 Pandemic: Is Telerehabilitation the Answer? Phys Ther. 2020 Aug 12;100(8):1260-1264. doi: 10.1093/ptj/pzaa093. No abstract available.
- Results publication: PubMed 40632682Shnitzer H, Chan J, Yau T, McIntyre M, Andreoli A, Kua A, Bayley M, Leochico CF, Guo M, Munce S. The Safety of Telerehabilitation: Systematic Review. JMIR Rehabil Assist Technol. 2025 Jul 9;12:e68681. doi: 10.2196/68681.
- Results publication: PubMed 35110818Quigley A, Johnson H, McArthur C. Transforming the Provision of Physiotherapy in the Time of COVID-19: A Call to Action for Telerehabilitation. Physiother Can. 2021 Winter;73(1):1-2. doi: 10.3138/ptc-2020-0031-gee.
- Results publication: PubMed 21160118Rogante M, Grigioni M, Cordella D, Giacomozzi C. Ten years of telerehabilitation: A literature overview of technologies and clinical applications. NeuroRehabilitation. 2010;27(4):287-304. doi: 10.3233/NRE-2010-0612.
- Results publication: PubMed 28733271Peretti A, Amenta F, Tayebati SK, Nittari G, Mahdi SS. Telerehabilitation: Review of the State-of-the-Art and Areas of Application. JMIR Rehabil Assist Technol. 2017 Jul 21;4(2):e7. doi: 10.2196/rehab.7511.
- Results publication: PubMed 37588949Ezell DJ, Malcarney HL. Rotator cuff repair rehabilitation considerations and respective guidelines: a narrative review. JSES Rev Rep Tech. 2021 May 13;1(3):179-185. doi: 10.1016/j.xrrt.2021.04.009. eCollection 2021 Aug.
- Results publication: PubMed 35494298Lee J, Griepp DW, Burgess CJ, Petrone B, Bitterman AD, Cohn RM. The AAOS 2019 Clinical Practice Guidelines for the Management of Rotator Cuff Injuries Are Unbiased and Incorporate a Diverse Body of Literature. Arthrosc Sports Med Rehabil. 2022 Mar 1;4(2):e559-e565. doi: 10.1016/j.asmr.2021.11.017. eCollection 2022 Apr.
- Individual participant dataSharing planned: No
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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.
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 and Conventional home exercise program in people with Rotator Cuff Tear and Telemedecine, run by Hanoi Medical University at 1 site in Vietnam.
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 13 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phuong D Pham, MD (84377072348, phuong.hmu.1992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Constant-Murley score from baseline to 24 weeks post-surgery (time frame: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair). 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?
On the ClinicalTrials.gov record for NCT07555704, which also lists 14 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 22 Sep 2026.