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Efficacy of Balance Training in Patients With Rotator Cuff Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by Dokuz Eylul University
Sponsor:
Information provided by (Responsible Party):
Ertan Sahinoglu, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT03054129
First received: February 13, 2017
Last updated: February 14, 2017
Last verified: February 2017
  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: 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 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 VAS 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
Anticipated Study Start Date: March 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: January 2019 (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, hot pack, stretching, strengthening and postural exercise.

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

Other: Rehabilitation and balance training

Firstly, we will use heat pack as a modality to affected shoulder. Then, stretching will be applied as hold-relax technique in PNF for shoulder flexion, abduction, internal and external rotations. Isotonic exercise will be done with elastic bands for strengthening.

Home exercises will include postural exercise, stretching and strengthening. Balance exercise 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, hot pack, stretching, strengthening and postural exercise.

Patients will also implement home exercise program.

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain due to unilateral rotator cuff disease at least four weeks.

Exclusion Criteria:

  • History of major surgery on the lower extremities
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03054129

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

Locations
Turkey
Dokuz Eylul University, Graduate School of Health Sciences Not yet recruiting
Izmir, Turkey
Principal Investigator: Ertan ŞAHİNOĞLU, MSc         
Sub-Investigator: Bayram ÜNVER, PhD         
Sub-Investigator: İzge Hakan GÜNAL, MD         
Sponsors and Collaborators
Dokuz Eylul University
Investigators
Principal Investigator: Ertan ŞAHİNOĞLU, MSc Dokuz Eylul University, Graduate School of Health Sciences
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
  More Information

Responsible Party: Ertan Sahinoglu, Principal Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03054129     History of Changes
Other Study ID Numbers: 2110-GOA 
Study First Received: February 13, 2017
Last Updated: February 14, 2017

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

ClinicalTrials.gov processed this record on February 24, 2017