Back to resultsEfficacy of Balance Training in Patients With Rotator Cuff Disease
Primary Purpose
Rotator Cuff Injury
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation and balance training
Rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injury
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
Sites / Locations
- Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehabilitation and balance training
Rehabilitation program
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Balance
Change of Tetrax Interactive Balance System scores (Stability Index, Fourier Transformation, Weight Distribution Index, Fall Index)
Secondary Outcome Measures
Functional limitations
Change of SPADI score
Change of quality of life
Change of WORC score
Change of pain
Change of numeric rating scale score (activity, rest and night)
Cognitive state
Cognitive functioning of patients assessed by Mini Mental State Examination
Full Information
NCT ID
NCT03054129
First Posted
February 13, 2017
Last Updated
September 15, 2020
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT03054129
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
September 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to determine whether balance training is effective in patients with rotator cuff disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation and balance training
Arm Type
Experimental
Arm Description
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.
Arm Title
Rehabilitation program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation and balance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation program
Intervention Description
Rehabilitation program will be same in this group except balance exercises.
Primary Outcome Measure Information:
Title
Balance
Description
Change of Tetrax Interactive Balance System scores (Stability Index, Fourier Transformation, Weight Distribution Index, Fall Index)
Time Frame
Before treatment and 6 weeks (end treatment)
Secondary Outcome Measure Information:
Title
Functional limitations
Description
Change of SPADI score
Time Frame
Before treatment and 6 weeks (end treatment)
Title
Change of quality of life
Description
Change of WORC score
Time Frame
Before treatment and 6 weeks (end treatment)
Title
Change of pain
Description
Change of numeric rating scale score (activity, rest and night)
Time Frame
Before treatment and 6 weeks (end treatment)
Title
Cognitive state
Description
Cognitive functioning of patients assessed by Mini Mental State Examination
Time Frame
Only before treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ertan ŞAHİNOĞLU, MSc
Organizational Affiliation
Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bayram ÜNVER, PhD
Organizational Affiliation
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Serkan ERKUŞ, MD
Organizational Affiliation
Tepecik Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kamil Yamak, MD
Organizational Affiliation
University of Health Sciences, İzmir Bozyaka Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
City
Izmir
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Balance Training in Patients With Rotator Cuff Disease
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