The Effect of Self-rehabilitation Using Communication APP After Arthroscopic Surgery for Rotator Cuff Tear
NCT ID: NCT05102968
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2019-03-22
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This prospective randomized case-control study was approved by the institutional review board of the Kaohsiung Veteran General Hospital (IRB No. KSVGH18-CT12-15) prior to enroll any patients. Patients were recruited if they had a small to medium-sized full-thickness rotator cuff tear or, a Lafosse type II or III subscapularis tear diagnosed and then repaired under shoulder arthroscope. After the surgery, patients were randomized either to the home-based rehabilitation (the home group) or the hospital supervised rehabilitation (the supervised group).
In the home group, patients self-managed rehabilitation exercise without supervision. Rehabilitation were supportive with the APP. Patient could communicate with the physician via the APP. In the supervised group, patients attended one-on-one instructions with therapists and exercised under supervision at hospital.
Patients' characters were recorded. Peri-operative factors associated with rotator cuff healing were assessed. The active ROM (forward elevation, abduction, external and internal rotation), the visual analogue scale (VAS) pain scores, the American shoulder and elbow surgeon shoulder (ASES) scores and the modified Constant scores were recorded pre-operatively and post-operatively 3, 6, 12 and 24 months. The isometric shoulder strength was assessed with the hand-held dynamometer. The compliance of post-operative rehabilitation was evaluated not only from patients' self-reported logs but also by physicians at post-operatively 6, 12 and 24 weeks. Tendon integrity was evaluated with MRI scan at least 6 months after the index surgery. In the pilot study, we found a mean difference of 4 points and a standard deviation of 5.5 points in the modified Constant scores. Power analysis revealed a total sample size of 62 patients (31 patients in each group) would achieve a statistical power of 0.8 with a two-tailed level of 0.05 to detect significant differences. Statistical level of significance was defined as p\<0.05.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients Registries- This prospective randomized case-control study was approved by the institutional review board of the Kaohsiung Veteran General Hospital (IRB No. KSVGH18-CT12-15) prior to enroll any patients. Eligible patients were determined by the attending surgeon. After the surgery, a research assistant conducted the informed consent process before the enrollment in the study. Subjects were randomized either to the home-based rehabilitation (the home group) or the hospital supervised rehabilitation (the supervised group). Each patient was assigned a study number in a consecutive sequence. A randomization sequence using two variables was determined by the mobile application. The allocation of two rehabilitation modes according to the randomization sequence was designated to each subject in a sealed envelope. The therapist opened envelopes at the 1st day post-operatively.
Surgical procedures- Arthroscopic rotator cuff repair for all patients were performed by a single senior surgeon (F.H) at Kaohsiung Veteran General Hospital. Under general anesthesia, patients sit on the beach-chair. The posterior, posterolateral, lateral, and anterolateral portals were created. Intra-articular lesions including subscapularis and biceps long-head tendon were evaluated via the posterior viewing portal. For a Lafosse type II or III tear, subscapularis was repaired with one or two anchors under posterior visualization. Tenotomy, tenodesis or labrum repair for biceps lesions was performed according to labrum tear pattern, age, and functional demand. Rotator cuff lesion was addressed while viewing from the lateral portal. The dimension of involved cuff from anterior to posterior was measured with a probe. Single- or double-row repair was performed based on tear size and pattern. Acromioplasty or partial distal clavicle resection was performed if indicated.
Rehabilitation protocol- All patients received the one standard rehabilitation protocol and used the booklet that described the rehabilitation exercise in detail. The 6-month rehabilitation protocol consisted of four stages. The first stage was the immobilization phase that patients wear the arm sling for 2-4 weeks. The second stage was the ROM phase that patients started from passive to assisted-active ROM for 4-6 weeks. The third stage was the low-tensity training phase that patients allowed active ROM and isokinetic elastic-band exercise for 4-8 weeks. The fourth stage was the joint stabilization phase that patients focused on training the muscle for scapular stabilization and continued isokinetic exercise at least 2 months post-operatively. All patients were follow-up in the clinic every 4-6 weeks after the surgery. After the clinical visit, they were instructed by therapists to perform exercise at home while proceeding the next rehabilitation stage. The exercise program was adjusted according to the recovery status of each patient.
Intervention- In the home group, patients managed rehabilitation exercise by themselves after the surgery without supervision. Rehabilitation protocol and exercise instruction video were available in the APP. Patient could communicate with the physician and therapist via the APP. In the supervised group, subjects attended one-on-one instructions with a therapist (once a week at post-operative 2nd\~12th week and once two weeks at post-operative 13th\~24th week; totally 16 sessions in the 6-month rehabilitation program) and exercised under supervision at hospital. Subjects would receive additional sessions based on the rehabilitation progress. Subjects could cancel scheduled sessions by personal reasons. We provided telephone consultation without APP communication for subjects in the supervised group.
Outcome evaluation- Patients characters including age, sex, body mass index, arm dominance, trauma history, education background and functional demand were recorded. Peri-operative factors associated with rotator cuff healing were assessed. The active ROM (forward elevation, abduction, external and internal rotation), the visual analogue scale (VAS) pain scores, the American shoulder and elbow surgeon shoulder (ASES) scores and the modified Constant scores were recorded by a research assistant preoperatively and post-operatively 3, 6, 12 and 24 months. Biceps, subscapularis, infraspinatus, and supraspinatus index were measured post-operatively 3, 6, 12 and 24 months. The compliance of post-operative rehabilitation was assessed at post-operatively 6, 12 and 24 weeks. Tendon integrity was evaluated with MRI scan (a 1.5-T unit) at least 6 months after the surgery.
Sample size analysis and statistics methods- In the pilot study, the investigators found a mean difference of 4 points and a standard deviation of 5.5 points in the modified Constant scores. Power analysis revealed a total sample size of 62 patients (31 patients in each group) would achieve a statistical power of 0.8 with a two-tailed level of 0.05 to detect significant differences. All statistical analyses were performed using the SPSS (version 23; IBM, Armonk, NY). Categorical data between groups were compared with the Pearson's chi-squared test or Fisher's exact test. Comparisons of normally distributed continuous data with the independent t-test and non-normally distributed continuous data with the rank sum test were performed. The analysis of covariance was used to compare the subjective scores (the VAS pain scores, ASES scores and modified Constant scores) and objective outcomes (active ROM and muscle index) between two groups. Statistical level of significance was defined as p\<0.05.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rehabilitation with mobile application
Patients self-managed rehab exercise with a supportive mobile application
Home-based rehabilitation supporting with the mobile application
For patients with mobile application supportive rehabilitation, patients managed rehabilitation exercise by themselves after the surgery without supervision. Rehabilitation protocol and exercise instruction video were available in the application. Patient could communicate with the physician and therapist via the application.
Rehabilitation under supervision
Patients received supervised physical therapy
Supervised rehabilitation by the therapist
For patients with therapist supervised rehabilitation, patients attended one-on-one instructions with a therapist (once a week at post-operative 2nd\~12th week and once two weeks at post-operative 13th\~24th week; totally 16 sessions in the 6-month rehabilitation program) and exercised under supervision at hospital. Subjects would receive additional sessions based on the rehabilitation progress. Subjects could cancel scheduled sessions by personal reasons. We provided telephone consultation without APP communication for subjects in the supervised group.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supervised rehabilitation by the therapist
For patients with therapist supervised rehabilitation, patients attended one-on-one instructions with a therapist (once a week at post-operative 2nd\~12th week and once two weeks at post-operative 13th\~24th week; totally 16 sessions in the 6-month rehabilitation program) and exercised under supervision at hospital. Subjects would receive additional sessions based on the rehabilitation progress. Subjects could cancel scheduled sessions by personal reasons. We provided telephone consultation without APP communication for subjects in the supervised group.
Home-based rehabilitation supporting with the mobile application
For patients with mobile application supportive rehabilitation, patients managed rehabilitation exercise by themselves after the surgery without supervision. Rehabilitation protocol and exercise instruction video were available in the application. Patient could communicate with the physician and therapist via the application.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients were willing to consent to post-operative rehabilitation randomization and commit to the two-year clinical follow-up period.
Exclusion Criteria
* an intra-operative irreparable cuff tear
* a prior ipsilateral shoulder surgery
* a history of systemic auto-immune disease or septic arthritis of the ipsilateral shoulder
20 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Futing Huang
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Linda Lin, PhD
Role: STUDY_DIRECTOR
Institute of Physical education, Health & Leisure Studies, National Cheng Kung University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaohsiung Veterns General Hospital
Kaohsiung City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Futing Huang, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Denard PJ, Ladermann A, Burkhart SS. Prevention and management of stiffness after arthroscopic rotator cuff repair: systematic review and implications for rotator cuff healing. Arthroscopy. 2011 Jun;27(6):842-8. doi: 10.1016/j.arthro.2011.01.013.
Thigpen CA, Shaffer MA, Gaunt BW, Leggin BG, Williams GR, Wilcox RB 3rd. The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Apr;25(4):521-35. doi: 10.1016/j.jse.2015.12.018.
Ross D, Maerz T, Lynch J, Norris S, Baker K, Anderson K. Rehabilitation following arthroscopic rotator cuff repair: a review of current literature. J Am Acad Orthop Surg. 2014 Jan;22(1):1-9. doi: 10.5435/JAAOS-22-01-1.
Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.
Ramey L, Osborne C, Kasitinon D, Juengst S. Apps and Mobile Health Technology in Rehabilitation: The Good, the Bad, and the Unknown. Phys Med Rehabil Clin N Am. 2019 May;30(2):485-497. doi: 10.1016/j.pmr.2018.12.001. Epub 2019 Mar 5.
Pires IM, Marques G, Garcia NM, Florez-Revuelta F, Ponciano V, Oniani S. A Research on the Classification and Applicability of the Mobile Health Applications. J Pers Med. 2020 Feb 27;10(1):11. doi: 10.3390/jpm10010011.
Alenabi T, Jackson M, Tetreault P, Begon M. Electromyographic activity in the immobilized shoulder musculature during ipsilateral elbow, wrist, and finger movements while wearing a shoulder orthosis. J Shoulder Elbow Surg. 2013 Oct;22(10):1400-7. doi: 10.1016/j.jse.2013.04.007. Epub 2013 Jun 14.
Cools AM, Dewitte V, Lanszweert F, Notebaert D, Roets A, Soetens B, Cagnie B, Witvrouw EE. Rehabilitation of scapular muscle balance: which exercises to prescribe? Am J Sports Med. 2007 Oct;35(10):1744-51. doi: 10.1177/0363546507303560. Epub 2007 Jul 2.
Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
Katolik LI, Romeo AA, Cole BJ, Verma NN, Hayden JK, Bach BR. Normalization of the Constant score. J Shoulder Elbow Surg. 2005 May-Jun;14(3):279-85. doi: 10.1016/j.jse.2004.10.009.
Holmgren T, Oberg B, Sjoberg I, Johansson K. Supervised strengthening exercises versus home-based movement exercises after arthroscopic acromioplasty: a randomized clinical trial. J Rehabil Med. 2012 Jan;44(1):12-8. doi: 10.2340/16501977-0889.
Buker N, Akkaya S, Akkaya N, Gokalp O, Kavlak E, Ok N, Kiter AE, Kitis A. Comparison of effects of supervised physiotherapy and a standardized home program on functional status in patients with total knee arthroplasty: a prospective study. J Phys Ther Sci. 2014 Oct;26(10):1531-6. doi: 10.1589/jpts.26.1531. Epub 2014 Oct 28.
Grant JA, Mohtadi NG. Two- to 4-year follow-up to a comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction. Am J Sports Med. 2010 Jul;38(7):1389-94. doi: 10.1177/0363546509359763. Epub 2010 Apr 1.
Krischak G, Gebhard F, Reichel H, Friemert B, Schneider F, Fisser C, Kaluscha R, Kraus M. A prospective randomized controlled trial comparing occupational therapy with home-based exercises in conservative treatment of rotator cuff tears. J Shoulder Elbow Surg. 2013 Sep;22(9):1173-9. doi: 10.1016/j.jse.2013.01.008. Epub 2013 Mar 22.
Roddey TS, Olson SL, Gartsman GM, Hanten WP, Cook KF. A randomized controlled trial comparing 2 instructional approaches to home exercise instruction following arthroscopic full-thickness rotator cuff repair surgery. J Orthop Sports Phys Ther. 2002 Nov;32(11):548-59. doi: 10.2519/jospt.2002.32.11.548.
Lisinski P, Huber J, Wilkosz P, Witkowska A, Wytrazek M, Samborski W, Zagloba A. Supervised versus uncontrolled rehabilitation of patients after rotator cuff repair-clinical and neurophysiological comparative study. Int J Artif Organs. 2012 Jan;35(1):45-54. doi: 10.5301/ijao.5000037.
Song SJ, Jeong TH, Moon JW, Park HV, Lee SY, Koh KH. Short-term Comparison of Supervised Rehabilitation and Home-based Rehabilitation for Earlier Recovery of Shoulder Motion, Pain, and Function after Rotator Cuff Repair. Clin Shoulder Elb. 2018 Mar 1;21(1):15-21. doi: 10.5397/cise.2018.21.1.15. eCollection 2018 Mar.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VGHKS 18-CT12-15
Identifier Type: -
Identifier Source: org_study_id