The Effect of Self-rehabilitation Using Communication APP After Arthroscopic Surgery for Rotator Cuff Tear

NCT05102968 | Recruiting DMC

• 1 other identifier: VGHKS 18-CT12-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to assess the clinical effect of a mobile application supporting home-based rehabilitation for the patients after arthroscopic rotator cuff repair. The investigators hypothesized the clinical results of the patients using a mobile application (APP) to support the home-based rehabilitation were comparable to the patients receiving the supervised rehabilitation. 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.

Conditions

Rotator Cuff Tears

Keywords

Rotator cuff tear; Arthroscopic surgery; Telerehabilitation

Outcome Measures

Primary Outcomes (2)

• The modified Constant scores

  The Constant scores (the total score - 100 maximal points) included both physical examination findings of motion and strength (65 points) and patient-reported subjective evaluation of shoulder function (35 points) to analyze the function of normal and diseased shoulders. The scale consisted of several sections: pain (15 points), patient-reported function with activities of daily living (20 points), range of motion (40 points), and strength testing (25 points). Finally, the scores was normalized to the age and sex of the subject as the modified Constant scores. A higher score indicates better shoulder function.

  post-op 6 months

• The modified Constant scores

  The Constant scores (the total score - 100 maximal points) included both physical examination findings of motion and strength (65 points) and patient-reported subjective evaluation of shoulder function (35 points) to analyze the function of normal and diseased shoulders. The scale consisted of several sections: pain (15 points), patient-reported function with activities of daily living (20 points), range of motion (40 points), and strength testing (25 points). Finally, the scores was normalized to the age and sex of the subject as the modified Constant scores. A higher score indicates better shoulder function.

  post-op 24 months

Secondary Outcomes (7)

• The American shoulder and elbow surgeon shoulder (ASES) scores

  post-op 6 months

• The American shoulder and elbow surgeon shoulder (ASES) scores

  post-op 24 months

• The degree of active range of motion (ROM) of shoulder joint

  post-op 6 months

• The degree of active range of motion (ROM) of shoulder joint

  post-op 24 months

• The biceps, subscapularis, Infraspinatus and supraspinatus index

  post-op 6 months

Other Outcomes (3)

• The grade of compliance of post-operative rehabilitation

  post-op 6 weeks

• The grade of compliance of post-operative rehabilitation

  post-op 12 weeks

• The grade of compliance of post-operative rehabilitation

  post-op 24 weeks

Study Arms (2)

Rehabilitation with mobile application

ACTIVE COMPARATOR

Patients self-managed rehab exercise with a supportive mobile application

Behavioral: Home-based rehabilitation supporting with the mobile application

Rehabilitation under supervision

ACTIVE COMPARATOR

Patients received supervised physical therapy

Behavioral: Supervised rehabilitation by the therapist

Interventions

Home-based rehabilitation supporting with the mobile application BEHAVIORAL

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.

Also known as: Home exercise

Rehabilitation with mobile application

Supervised rehabilitation by the therapist BEHAVIORAL

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.

Also known as: Supervised exercise

Rehabilitation under supervision

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients had a small to medium-sized (less than 3 cm) full-thickness rotator cuff tear or, a Lafosse type II or III subscapularis tear diagnosed and repaired by shoulder arthroscope
• patients were willing to consent to post-operative rehabilitation randomization and commit to the two-year clinical follow-up period.

You may not qualify if:

• pre-operative shoulder stiffness (defined as passive forward elevation less than 100 degrees and external rotation loss over 50% comparing to the contralateral side)
• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterns General Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Related Publications (17)

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  PMID: 21624680 BACKGROUND

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  PMID: 26995456 BACKGROUND

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  PMID: 15889027 BACKGROUND

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  PMID: 25364104 RESULT

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  PMID: 20360607 RESULT

• 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.

  PMID: 23523073 RESULT

• 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.

  PMID: 12449254 RESULT

• 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.

  PMID: 22287203 RESULT

• 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.

  PMID: 33330146 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Linda Lin, PhD

  Institute of Physical education, Health & Leisure Studies, National Cheng Kung University

  STUDY DIRECTOR

Central Study Contacts

Futing Huang, MD

CONTACT

886-910775551; fthuang@vghks.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 2, 2021
• Study Start: March 22, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)