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NCT03054129 Clinical Trial

Efficacy of Balance Training in Patients With Rotator Cuff Disease

Rotator Cuff Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03054129
Other study ID # 2110-GOA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2017
Est. completion date September 21, 2019

Study information
Verified date March 2023
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date September 21, 2019
Est. primary completion date August 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Dr. Ismail Atabek Physical Therapy and Rehabilitation Center Izmir

Sponsors (1)
Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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 Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
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. Before treatment and 6 weeks (end of the treatment)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Cognitive State Cognitive functioning of patients assessed by Mini Mental State Examination Score range 0 (worst) to 30 (best). Only before treatment
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