Efficacy of Balance Training in Patients With Rotator Cuff Disease

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

Official Title
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Efficacy of Balance Training in Patients With Rotator Cuff Disease: A Randomized Controlled Trial

Conditions
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Rotator Cuff Injury

Intervention / Treatment
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* Other: Rehabilitation and balance training
* Other: Rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation and balance training<br>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<br>* Stretching will be applied as hold-relax technique in Proprioceptive Neuromuscular Facilitation 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.<br>|
| Active Comparator: Rehabilitation program<br>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<br>* Rehabilitation program will be same in this group except balance exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Control-Stability Index in Solid Surface - Eyes Open | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Stability Index in Solid Surface - Eyes Closed | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Stability Index in Standing on Pillows - Eyes Open | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Stability Index in Standing on Pillows - Eyes Closed | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Stability Index in Head Turned Right 45° - Eyes Closed | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Stability Index in Head Turn Left About 45° - Eyes Closed | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Stability Index in Head Raised Backward 30° - Eyes Closed | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Stability Index in Head Downward 30° - Eyes Closed | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Open | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Open | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Head Turned Right 45° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Head Turn Left About 45° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Head Raised Backward 30° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F5) in Head Downward 30° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Open | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Open | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Head Turned Right 45° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Head Turn Left About 45° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Head Raised Backward 30° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fourier Transformation (F6) in Head Downward 30° - Eyes Closed | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Solid Surface - Eyes Open | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Solid Surface - Eyes Closed | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Open | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Closed | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Head Turned Right 45° - Eyes Closed | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Head Turn Left About 45° - Eyes Closed | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Head Raised Backward 30° - Eyes Closed | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Weight Distribution Index in Head Downward 30° - Eyes Closed | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. | Before treatment and 6 weeks (end of the treatment) | 
| Postural Control-Fall Index | Fall Index obtained by Tetrax Interactive Balance System Minimum value = 0, Maximum value = 100. A higher value indicating a greater chance of falling. | Before treatment and 6 weeks (end of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Quality of Life | Change of Western Ontario Rotator Cuff Index score Total score range 0 (worst) to 2,100 (best). | Before treatment and 6 weeks (end treatment) | 
| Functional Limitations | Change of Shoulder Pain and Disability Index score Total score 0-100. A higher score indicates worse pain and disability. | Before treatment and 6 weeks (end treatment) | 
| Change of Pain | Change of numeric rating scale score (activity, rest and night) 0 = no pain, 10 = worst possible pain | Before treatment and 6 weeks (end treatment) | 
| Cognitive State | Cognitive functioning of patients assessed by Mini Mental State Examination Score range 0 (worst) to 30 (best). | Only before treatment |