NCT06156423

Brief Summary

The aim of the study is to examine the effect of motor control exercises given through telerehabilitation on shoulder function and quality of life in patients undergoing rotator cuff surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 13, 2026

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

November 26, 2023

Last Update Submit

January 11, 2026

Conditions

Keywords

rotator cuff surgerytelerehabilitationmotor control

Outcome Measures

Primary Outcomes (11)

  • Pain Assessment

    Pain assessment will be evaluated with the Visual Analog Scale (VAS) before surgery, at the 6th week and at the 12th week after surgery, during activity, rest and sleep. As the score increases, it indicates that the pain increases.

    Preoperative, postoperative 6th week and postoperative 12th week

  • Shoulder Range of Motion Assessment

    Range of motion of the shoulder will be evaluated with a electrogoniometer. Evaluations will be made actively for shoulder flexion, abduction, internal and external rotation and active total elevation

    Preoperative, postoperative 6th week and postoperative 12th week

  • Active Internal Rotation Assessment

    In active internal rotation of the shoulder, the distance between the thumb and the T5 spinous process will be measured with a tape measure.

    Preoperative, postoperative 6th week and postoperative 12th week

  • Scapular Dyskinesis Assessment

    Scapular dyskinesis will be evaluated with the lateral scapular glide test.

    Preoperative, postoperative 6th week and postoperative 12th week

  • Shoulder muscle strength assessment

    Shoulder abduction, flexion, internal and external rotation and scaption muscle strength will be measured with a dynamometer.

    Preoperative and postoperative 12th week

  • Grip strength assessment

    Grip strength will be evaluated with a Jamar hand dynamometer.

    Preoperative and postoperative 12th week

  • Shoulder function assessment

    Shoulder function will be evaluated with Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. The total score is 100, with higher scores indicating more disability.

    Preoperative, postoperative 6th week and postoperative 12th week

  • Shoulder function assessment

    Other shoulder function assessment will be evaluated with American Shoulder and Elbow Surgeons Scale (ASES). A combination of these scores will yield an ASES score ranging from 0 (absence of function) to 100 (normal function).

    Preoperative, postoperative 6th week and postoperative 12th week

  • Kinesiophobia Assessment

    Kinesiophobia assessment will be evaluated with Tampa Scale of Kinesiophobia. The total score varies between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia.

    Preoperative, postoperative 6th week and postoperative 12th week

  • Sleep quality assessment

    Sleep quality will be evaluated with Pittsburgh Sleep Quality Index (PSQI). The overall score ranges from 0 to 21. Lower scores indicate better sleep quality.

    Preoperative, postoperative 6th week and postoperative 12th week

  • Quality of Life Assessment

    Quality of life will be evaluated with the Western Ontario Rotator Cuff Index (WORC), specific to rotator cuff injuries. The total score ranges from 0 to 2100, with lower scores indicating higher quality of life.

    Preoperative, postoperative 6th week and postoperative 12th week

Study Arms (2)

Motor Control Rehabilitation

EXPERIMENTAL
Other: Motor control exercise

Standard Rehabilitation

ACTIVE COMPARATOR
Other: Standard exercise

Interventions

Motor control exercises include stabilization exercises for the scapula with external focus by activating the correct alignment and kinetic chain by providing verbal feedback and visual feedback.

Motor Control Rehabilitation

The standard rehabilitation group received a rehabilitation program via video call 3 days a week for 12 weeks.

Standard Rehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergone rotator cuff surgery
  • being 18 years of age
  • agree to participate in the study,
  • allowed early rehabilitation after surgery,
  • can speak and understand Turkish
  • can make video conferences and phone calls.

You may not qualify if:

  • have had previous surgery on the affected shoulder,
  • have neurological deficits and motor control disorders,
  • have systemic rheumatological disease,
  • have developed any complications that may affect rehabilitation in the shoulder,
  • have had revision surgery on the affected shoulder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinem Yenil

Denizli, Denizli, 20060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

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
Investigator

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 5, 2023

Study Start

September 10, 2023

Primary Completion

February 12, 2025

Study Completion

June 1, 2025

Last Updated

January 13, 2026

Record last verified: 2023-12

Locations