We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Balance Training in Patients With Rotator Cuff Disease

This study is currently recruiting participants.
Verified August 2017 by Ertan Sahinoglu, Dokuz Eylul University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03054129
First Posted: February 15, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ertan Sahinoglu, Dokuz Eylul University
  Purpose
The purpose of the study is to determine whether balance training is effective in patients with rotator cuff disease.

Condition Intervention
Rotator Cuff Injury Other: Rehabilitation and balance training Other: Rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Balance Training in Patients With Rotator Cuff Disease: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ertan Sahinoglu, Dokuz Eylul University:

Primary Outcome Measures:
  • Balance [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of Tetrax Interactive Balance System scores.


Secondary Outcome Measures:
  • Functional limitations [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of SPADI score

  • Quality of life [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of WORC score

  • Pain [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of numeric rating scale score (activity, rest and night)

  • Range of Motion [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of range of motion (with universal goniometer)

  • Strength [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of muscle strength (with hand held dynamometer)


Estimated Enrollment: 42
Actual Study Start Date: June 7, 2017
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation and balance training

Each patient will attend rehabilitation program for three days per week for six weeks. Patients will receive balance training in addition to supervised rehabilitation program which is including patient education, stretching and strengthening exercises.

Patients will also implement home exercise program. Balance training will be non-supervised program.

Other: Rehabilitation and balance training

Stretching will be applied as hold-relax technique in PNF for shoulder flexion, abduction, internal and external rotations. Isotonic exercises will be done with elastic bands for strengthening.

Home exercises will include postural, stretching and strengthening exercises. Balance exercises will receive as non-supervised program.

Active Comparator: Rehabilitation program

Each patient will attend rehabilitation program for three days per week for six weeks.

Patients will receive supervised rehabilitation program which is including patient education, stretching and strengthening exercises.

Patients will also implement home exercise program.

Other: Rehabilitation program
Rehabilitation program will be same in this group except balance exercises.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054129


Contacts
Contact: Ertan ŞAHİNOĞLU, MSc +905326478653 ertan.sahinoglu@hotmail.com

Locations
Turkey
Dr. İsmail Atabek Physical Therapy and Rehabilitation Center Recruiting
Izmir, Turkey
Principal Investigator: Ertan ŞAHİNOĞLU, MSc         
Sub-Investigator: Bayram ÜNVER, PhD         
Sub-Investigator: İzge Hakan GÜNAL, MD         
Sub-Investigator: Serkan ERKUŞ, MD         
Sponsors and Collaborators
Dokuz Eylul University
Investigators
Principal Investigator: Ertan ŞAHİNOĞLU, MSc Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
Study Director: Bayram ÜNVER, PhD Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Study Director: İzge Hakan GÜNAL, MD Dokuz Eylul University, Faculty of Medicine
Study Director: Serkan ERKUŞ, MD Tepecik Training and Research Hospital
  More Information

Responsible Party: Ertan Sahinoglu, Principal Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03054129     History of Changes
Other Study ID Numbers: 2110-GOA
First Submitted: February 13, 2017
First Posted: February 15, 2017
Last Update Posted: November 20, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries