NCT05266339

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

May 20, 2025

Status Verified

June 1, 2024

Enrollment Period

2.3 years

First QC Date

February 28, 2022

Last Update Submit

May 17, 2025

Conditions

Rotator Cuff TearsPain, ShoulderSurgery

Outcome Measures

Primary Outcomes (1)

  • Constant-Murley Score

    The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.

    Baseline

Secondary Outcomes (17)

  • Constant-Murley Score

    At the end of 8-week intervention

  • Constant-Murley Score

    1-month follow-up after intervention

  • Visual Analogue Scale

    Baseline

  • Visual Analogue Scale

    At the end of 8-week intervention

  • Visual Analogue Scale

    1-month follow-up after intervention

  • +12 more secondary outcomes

Study Arms (2)

Cross-education group

EXPERIMENTAL

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.

Other: Cross-education trainingOther: Standard exercise program

Standard exercise group

ACTIVE COMPARATOR

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

Other: Standard exercise program

Interventions

Cross-education trainingOTHER

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

Cross-education group
Standard exercise programOTHER

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.

Cross-education groupStandard exercise group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tansu Birinci, PT, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 4, 2022

Study Start

May 9, 2022

Primary Completion

August 15, 2024

Study Completion

August 15, 2025

Last Updated

May 20, 2025

Record last verified: 2024-06

Locations

TU(1)