Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial

NCT ID: NCT05266339

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2025-08-15

Brief Summary

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This randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair.

Detailed Description

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Fifty voluntary patients who underwent arthroscopic rotator cuff repair, aged between 35-64 years will be randomly divided into two groups: Cross-education group and standard rehabilitation group. Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline, at the end of the 8-week intervention and 1-month follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status will be evaluated by Constant-Murley Score (CMS) and American Shoulder and Elbow Surgeons (ASES) Score. Health-related quality of life will be assessed with Short Form-12 (SF-12). The Global Rating of Change will be used to evaluate patient satisfaction.

Conditions

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Rotator Cuff Tears Pain, Shoulder Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cross-education group

Each subject in the cross-education group will receive a treatment protocol consisting of cross-education (training of the contralateral limb) and standard exercise program applied after arthroscopic rotator cuff repair.

Group Type EXPERIMENTAL

Cross-education training

Intervention Type OTHER

The strengthening exercises for rotator cuff muscles will be performed in the contralateral side of the affected side.

Standard exercise program

Intervention Type OTHER

The standard exercise program, which prepared according to The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair, will be applied.

Standard exercise group

Each subject in the standard exercise group will receive a treatment protocol consisting of standard exercise program applied after arthroscopic rotator cuff repair.

Group Type ACTIVE_COMPARATOR

Standard exercise program

Intervention Type OTHER

The standard exercise program, which prepared according to The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair, will be applied.

Interventions

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Cross-education training

The strengthening exercises for rotator cuff muscles will be performed in the contralateral side of the affected side.

Intervention Type OTHER

Standard exercise program

The standard exercise program, which prepared according to The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair, will be applied.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Being aged between 35-65 years Having undergone arthroscopic rotator cuff repair surgery Having the ability to read and write Turkish

Exclusion Criteria

Revision surgery or previous shoulder surgery Having undergone subscapularis tendon repair in addition to arthroscopic rotator cuff repair Having scoliosis surgery or a health problem that will cause limitation in spinal mobility Restriction of movement or absence of limb in the opposite upper extremity Having frozen shoulder Presence of glenohumeral instability Having been diagnosed with thoracic outlet syndrome Presence of upper extremity fracture or tumor Having been diagnosed with cervical radiculopathy Having been diagnosed with any malignant condition, systemic, neurological or rheumatological disease Having a skin disease or hearing-vision problem that will affect the evaluation process
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Tansu Birinci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tansu Birinci, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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109

Identifier Type: -

Identifier Source: org_study_id

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