Remote App-based Rehabilitation After Rotator Cuff Repair

NCT07555704 | Not Yet Recruiting DMC

• 1 other identifier: 01250212
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Telemedecine; Rotator Cuff Tear; Rotator Cuff Injuries

Keywords

Rotator Cuff Tears; Rotator Cuff Injuries; Telerehabilitation; Mobile Application; Digital Health; Arthroscopic Rotator Cuff Repair

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively

• Change in isometric shoulder strength from baseline to 24 weeks

  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

  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

  Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively.

• Rotator cuff re-tear rate at 24 weeks post-operatively

  At 24 weeks after arthroscopic rotator cuff repair

Study Arms (2)

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.

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.

Procedure: Conventional home exercise program

Interventions

Telerehabilitation PROCEDURE

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.

Also known as: App-based home exercise program, Mobile Health rehabilitation

Experimental Group

Conventional home exercise program PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical University

Hanoi, 100000, Vietnam

Location

Related Publications (14)

• 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.

  PMID: 33935152 RESULT

• Agostini 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.

  PMID: 40806982 RESULT

• Shim 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.

  PMID: 37221303 RESULT

• Zhang 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.

  PMID: 39143625 RESULT

• Phuphanich 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.

  PMID: 33814061 RESULT

• Turolla 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.

  PMID: 32386218 RESULT

• Shnitzer 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.

  PMID: 40632682 RESULT

• Quigley 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.

  PMID: 35110818 RESULT

• Rogante 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.

  PMID: 21160118 RESULT

• Peretti 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.

  PMID: 28733271 RESULT

• Ezell 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.

  PMID: 37588949 RESULT

• Lee 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.

  PMID: 35494298 RESULT

• Peltz 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.

  PMID: 20058271 RESULT

• Lv 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.

  PMID: 36110187 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Phuong D Pham, MD

CONTACT

84377072348; phuong.hmu.1992@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors responsible for evaluating clinical endpoints, such as the Constant-Murley score, Quick DASH score and range of motion, muscle strength, are blinded to the treatment group assignment of the participants to ensure objectivity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)