Rotator Cuff Injury
Conditions
Brief summary
The purpose of the study is to determine whether balance training is effective in patients with rotator cuff disease.
Interventions
OTHERRehabilitation and balance training
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.
OTHERRehabilitation program
Rehabilitation program will be same in this group except balance exercises.
Sponsors
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postural Control-Stability Index in Solid Surface - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Stability Index in Solid Surface - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Stability Index in Standing on Pillows - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Stability Index in Standing on Pillows - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Stability Index in Head Turned Right 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Stability Index in Head Turn Left About 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Stability Index in Head Raised Backward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Stability Index in Head Downward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Stability Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower score indicates better postural stability. |
| Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F5) in Head Turned Right 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F5) in Head Turn Left About 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F5) in Head Raised Backward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F5) in Head Downward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Head Turned Right 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Head Turn Left About 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Head Raised Backward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Fourier Transformation (F6) in Head Downward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Fourier transformation obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability |
| Postural Control-Weight Distribution Index in Solid Surface - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Weight Distribution Index in Solid Surface - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Open | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Weight Distribution Index in Head Turned Right 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Weight Distribution Index in Head Turn Left About 45° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Weight Distribution Index in Head Raised Backward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Weight Distribution Index in Head Downward 30° - Eyes Closed | Before treatment and 6 weeks (end of the treatment) | Weight Distribution Index obtained by Tetrax Interactive Balance System No specified a minimum and maximum value. A lower value indicates higher stability. |
| Postural Control-Fall Index | Before treatment and 6 weeks (end of the treatment) | Fall Index obtained by Tetrax Interactive Balance System Minimum value = 0, Maximum value = 100. A higher value indicating a greater chance of falling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Quality of Life | Before treatment and 6 weeks (end treatment) | Change of Western Ontario Rotator Cuff Index score Total score range 0 (worst) to 2,100 (best). |
| Functional Limitations | Before treatment and 6 weeks (end treatment) | Change of Shoulder Pain and Disability Index score Total score 0-100. A higher score indicates worse pain and disability. |
| Change of Pain | Before treatment and 6 weeks (end treatment) | Change of numeric rating scale score (activity, rest and night) 0 = no pain, 10 = worst possible pain |
| Cognitive State | Only before treatment | Cognitive functioning of patients assessed by Mini Mental State Examination Score range 0 (worst) to 30 (best). |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Rehabilitation program: Rehabilitation program will be same in this group except balance exercises. | 19 |
| 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.
Rehabilitation and balance training: 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. | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Rehabilitation Program | Rehabilitation and Balance Training | Total |
|---|---|---|---|
| Affected shoulder Dominant | 15 participants | 11 participants | 26 participants |
| Affected shoulder Nondominant | 4 participants | 9 participants | 13 participants |
| Age, Continuous | 46 years | 50 years | 49 years |
| Body mass index | 27.54 kg/m^2 | 25.90 kg/m^2 | 25.95 kg/m^2 |
| Comorbidities Diabetes mellitus | 1 participants | 2 participants | 3 participants |
| Comorbidities Hypertension | 0 participants | 5 participants | 5 participants |
| Comorbidities Lung disease | 0 participants | 1 participants | 1 participants |
| Comorbidities No comorbidity | 18 participants | 9 participants | 27 participants |
| Comorbidities Other medical problems | 0 participants | 3 participants | 3 participants |
| Diagnosis Subacromial impingement syndrome | 6 participants | 8 participants | 14 participants |
| Diagnosis Supraspinatus full thickness tear | 3 participants | 1 participants | 4 participants |
| Diagnosis Supraspinatus+infraspinatus partial thickness tear | 2 participants | 0 participants | 2 participants |
| Diagnosis Supraspinatus partial thickness tear | 7 participants | 8 participants | 15 participants |
| Diagnosis Supraspinatus + subscapularis tendinopathy | 0 participants | 1 participants | 1 participants |
| Diagnosis Supraspinatus tendinopathy | 1 participants | 2 participants | 3 participants |
| Education level College graduate | 6 participants | 10 participants | 16 participants |
| Education level High school graduate | 5 participants | 6 participants | 11 participants |
| Education level Less than high school | 8 participants | 4 participants | 12 participants |
| Employment status Not working | 0 participants | 6 participants | 6 participants |
| Employment status Retired | 4 participants | 3 participants | 7 participants |
| Employment status Working | 15 participants | 11 participants | 26 participants |
| Pain duration | 16 weeks | 22 weeks | 20 weeks |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 23 Participants |
| Smoking habit Nonsmoker | 9 participants | 9 participants | 18 participants |
| Smoking habit Smoker | 10 participants | 11 participants | 21 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fall Index | -2.00 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Fall Index | -1.00 score on a scale |
p-value: 0.508Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Head Downward 30° - Eyes Closed | 0.07 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Head Downward 30° - Eyes Closed | -0.54 Hz |
p-value: 0.129Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Head Raised Backward 30° - Eyes Closed | 0.63 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Head Raised Backward 30° - Eyes Closed | -0.21 Hz |
p-value: 0.152Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Head Turned Right 45° - Eyes Closed | 1.04 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Head Turned Right 45° - Eyes Closed | -0.35 Hz |
p-value: 0.04Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Head Turn Left About 45° - Eyes Closed | 0.19 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Head Turn Left About 45° - Eyes Closed | 0.25 Hz |
p-value: 0.779Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Closed | 0.04 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Closed | -0.72 Hz |
p-value: 0.136Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Open | 0.29 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Solid Surface - Eyes Open | 0.16 Hz |
p-value: 0.933Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Closed | -0.67 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Closed | -1.03 Hz |
p-value: 0.715Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Open | -0.55 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F5) in Standing on Pillows - Eyes Open | 0.07 Hz |
p-value: 0.673Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Head Downward 30° - Eyes Closed | 0.44 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Head Downward 30° - Eyes Closed | -0.25 Hz |
p-value: 0.012Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Head Raised Backward 30° - Eyes Closed | 0.18 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Head Raised Backward 30° - Eyes Closed | -0.23 Hz |
p-value: 0.112Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Head Turned Right 45° - Eyes Closed | -0.02 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Head Turned Right 45° - Eyes Closed | 0.14 Hz |
p-value: 0.933Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Head Turn Left About 45° - Eyes Closed | 0.04 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Head Turn Left About 45° - Eyes Closed | 0.04 Hz |
p-value: 0.684Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Closed | 0.04 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Closed | 0.22 Hz |
p-value: 0.978Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Open | 0.24 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Solid Surface - Eyes Open | 0.14 Hz |
p-value: 0.384Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Closed | -0.42 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Closed | 0.83 Hz |
p-value: 0.546Wilcoxon (Mann-Whitney)
Primary
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
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Open | -0.12 Hz |
| Rehabilitation and Balance Training | Postural Control-Fourier Transformation (F6) in Standing on Pillows - Eyes Open | 0.27 Hz |
p-value: 0.715Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Head Downward 30° - Eyes Closed | 1.88 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Head Downward 30° - Eyes Closed | -0.48 score on a scale |
p-value: 0.016Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Head Raised Backward 30° - Eyes Closed | 2.15 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Head Raised Backward 30° - Eyes Closed | 2.42 score on a scale |
p-value: 0.339Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Head Turned Right 45° - Eyes Closed | 2.42 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Head Turned Right 45° - Eyes Closed | 0.61 score on a scale |
p-value: 0.191Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Head Turn Left About 45° - Eyes Closed | 2.62 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Head Turn Left About 45° - Eyes Closed | -0.33 score on a scale |
p-value: 0.097Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Solid Surface - Eyes Closed | 0.74 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Solid Surface - Eyes Closed | -2.37 score on a scale |
p-value: 0.361Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Solid Surface - Eyes Open | 1.06 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Solid Surface - Eyes Open | 2.00 score on a scale |
p-value: 0.866Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Standing on Pillows - Eyes Closed | -0.52 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Standing on Pillows - Eyes Closed | -0.31 score on a scale |
p-value: 0.978Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Stability Index in Standing on Pillows - Eyes Open | 1.40 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Stability Index in Standing on Pillows - Eyes Open | 0.71 score on a scale |
p-value: 0.715Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Head Downward 30° - Eyes Closed | -0.47 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Head Downward 30° - Eyes Closed | -0.81 score on a scale |
p-value: 0.593Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Head Raised Backward 30° - Eyes Closed | -0.71 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Head Raised Backward 30° - Eyes Closed | -0.91 score on a scale |
p-value: 0.715Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Head Turned Right 45° - Eyes Closed | -0.25 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Head Turned Right 45° - Eyes Closed | -0.35 score on a scale |
p-value: 0.844Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Head Turn Left About 45° - Eyes Closed | -1.97 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Head Turn Left About 45° - Eyes Closed | -0.57 score on a scale |
p-value: 0.122Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Solid Surface - Eyes Closed | 0.11 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Solid Surface - Eyes Closed | -0.62 score on a scale |
p-value: 0.736Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Solid Surface - Eyes Open | -0.43 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Solid Surface - Eyes Open | 0.47 score on a scale |
p-value: 0.633Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Closed | -1.57 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Closed | 1.21 score on a scale |
p-value: 0.109Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Before treatment and 6 weeks (end of the treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Open | -1.74 score on a scale |
| Rehabilitation and Balance Training | Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Open | -0.19 score on a scale |
p-value: 0.227Wilcoxon (Mann-Whitney)
Secondary
Change of Pain
Change of numeric rating scale score (activity, rest and night) 0 = no pain, 10 = worst possible pain
Time frame: Before treatment and 6 weeks (end treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rehabilitation Program | Change of Pain | Before treatment-on movement | 5 units on a scale |
| Rehabilitation Program | Change of Pain | Before treatment-at rest | 0 units on a scale |
| Rehabilitation Program | Change of Pain | Before treatment-at night | 6 units on a scale |
| Rehabilitation Program | Change of Pain | After treatment-on movement | 0 units on a scale |
| Rehabilitation Program | Change of Pain | After treatment-at rest | 0 units on a scale |
| Rehabilitation Program | Change of Pain | After treatment-at night | 0 units on a scale |
| Rehabilitation and Balance Training | Change of Pain | After treatment-at rest | 0 units on a scale |
| Rehabilitation and Balance Training | Change of Pain | Before treatment-on movement | 7 units on a scale |
| Rehabilitation and Balance Training | Change of Pain | After treatment-on movement | 1 units on a scale |
| Rehabilitation and Balance Training | Change of Pain | Before treatment-at rest | 0.50 units on a scale |
| Rehabilitation and Balance Training | Change of Pain | After treatment-at night | 0.50 units on a scale |
| Rehabilitation and Balance Training | Change of Pain | Before treatment-at night | 7 units on a scale |
p-value: 0Wilcoxon (Mann-Whitney)
Secondary
Change of Quality of Life
Change of Western Ontario Rotator Cuff Index score Total score range 0 (worst) to 2,100 (best).
Time frame: Before treatment and 6 weeks (end treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Change of Quality of Life | 42.38 score on a scale |
| Rehabilitation and Balance Training | Change of Quality of Life | 36.43 score on a scale |
p-value: 0.565Wilcoxon (Mann-Whitney)
Secondary
Cognitive State
Cognitive functioning of patients assessed by Mini Mental State Examination Score range 0 (worst) to 30 (best).
Time frame: Only before treatment
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rehabilitation Program | Cognitive State | 25 score on a scale |
| Rehabilitation and Balance Training | Cognitive State | 26 score on a scale |
p-value: 0.357Wilcoxon (Mann-Whitney)
Secondary
Functional Limitations
Change of Shoulder Pain and Disability Index score Total score 0-100. A higher score indicates worse pain and disability.
Time frame: Before treatment and 6 weeks (end treatment)
Population: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rehabilitation Program | Functional Limitations | Before treatment-Disability | 47.50 score on a scale |
| Rehabilitation Program | Functional Limitations | After treatment-Pain | 4.00 score on a scale |
| Rehabilitation Program | Functional Limitations | After treatment-Disability | 2.50 score on a scale |
| Rehabilitation Program | Functional Limitations | Before treatment-Total | 60.00 score on a scale |
| Rehabilitation Program | Functional Limitations | After treatment-Total | 5.38 score on a scale |
| Rehabilitation Program | Functional Limitations | Before treatment-Pain | 70.00 score on a scale |
| Rehabilitation and Balance Training | Functional Limitations | After treatment-Total | 15.38 score on a scale |
| Rehabilitation and Balance Training | Functional Limitations | Before treatment-Pain | 76.00 score on a scale |
| Rehabilitation and Balance Training | Functional Limitations | Before treatment-Disability | 53.75 score on a scale |
| Rehabilitation and Balance Training | Functional Limitations | Before treatment-Total | 64.58 score on a scale |
| Rehabilitation and Balance Training | Functional Limitations | After treatment-Pain | 17.00 score on a scale |
| Rehabilitation and Balance Training | Functional Limitations | After treatment-Disability | 10.00 score on a scale |
p-value: 0Wilcoxon (Mann-Whitney)