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Efficacy of Balance Training in Patients With Rotator Cuff Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054129
Recruitment Status : Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ertan Sahinoglu, Dokuz Eylul University

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

Condition or disease Intervention/treatment Phase
Rotator Cuff Injury Other: Rehabilitation and balance training Other: Rehabilitation program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Balance Training in Patients With Rotator Cuff Disease: A Randomized Controlled Trial
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : August 6, 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Balance [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of Tetrax Interactive Balance System scores (Stability Index, Fourier Transformation, Weight Distribution Index, Fall Index)


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

  2. Change of quality of life [ Time Frame: Before treatment and 6 weeks (end treatment) ]
    Change of WORC score

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

  4. Cognitive state [ Time Frame: Only before treatment ]
    Cognitive functioning of patients assessed by Mini Mental State Examination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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


Locations
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Turkey
Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
Izmir, Turkey
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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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
Principal Investigator: Serkan ERKUŞ, MD Tepecik Training and Research Hospital
Principal Investigator: Kamil Yamak, MD University of Health Sciences, İzmir Bozyaka Education and Research Hospital

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Responsible Party: Ertan Sahinoglu, Principal Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03054129    
Other Study ID Numbers: 2110-GOA
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries