Clinical trial NCT03054129: Efficacy of Balance Training in Patients With Rotator Cuff Disease
Official title: Efficacy of Balance Training in Patients With Rotator Cuff Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injury
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether balance training is effective in patients with rotator cuff disease.


Eligibility criteria: Inclusion Criteria:

* Verification of the diagnosis of rotator cuff disease by a medical practitioner via radiological techniques.
* Pain due to unilateral rotator cuff disease at least four weeks.

Exclusion Criteria:

* Systemic pathology including inflammatory joint disease.
* More than %50 restriction of passive range of motion in two or more planes.
* History of major surgery on the lower extremities and shoulder regions.
* Acute or chronic pain in the spine or lower extremities.
* An injury of the lower extremities during the last six months which affected functional capabilities.
* Any kind of neurological complaint.
* Cardiovascular diseases which affect balance.
* Acute dizziness
* Medications which affected balance
* Subjects who performed balance training

Primary outcomes:
measure: Postural Control-Stability Index in Solid Surface - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Stability Index in Solid Surface - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Stability Index in Standing on Pillows - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Stability Index in Standing on Pillows - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Stability Index in Head Turned Right 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Stability Index in Head Turn Left About 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Stability Index in Head Raised Backward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Stability Index in Head Downward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Head Turned Right 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Head Turn Left About 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Head Raised Backward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F5) in Head Downward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Head Turned Right 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Head Turn Left About 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Head Raised Backward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fourier Transformation (F6) in Head Downward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Solid Surface - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Solid Surface - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Open
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Head Turned Right 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Head Turn Left About 45° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Head Raised Backward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Weight Distribution Index in Head Downward 30° - Eyes Closed
timeFrame: Before treatment and 6 weeks (end of the treatment)
measure: Postural Control-Fall Index
timeFrame: Before treatment and 6 weeks (end of the treatment)
Secondary outcomes:
measure: Change of Quality of Life
timeFrame: Before treatment and 6 weeks (end treatment)
measure: Functional Limitations
timeFrame: Before treatment and 6 weeks (end treatment)
measure: Change of Pain
timeFrame: Before treatment and 6 weeks (end treatment)
measure: Cognitive State
timeFrame: Only before treatment
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
Study officials:
affiliation: Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
name: Ertan ŞAHİNOĞLU, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University, School of Physical Therapy and Rehabilitation
name: Bayram ÜNVER, PhD
role: STUDY_DIRECTOR
affiliation: Tepecik Training and Research Hospital
name: Serkan ERKUŞ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences, İzmir Bozyaka Education and Research Hospital
name: Kamil Yamak, MD
role: PRINCIPAL_INVESTIGATOR
References: