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Clinical Trials/NCT03054129
NCT03054129
Completed
N/A

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

Dokuz Eylul University1 site in 1 country42 target enrollmentJune 7, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rotator Cuff Injury
Sponsor
Dokuz Eylul University
Enrollment
42
Locations
1
Primary Endpoint
Postural Control-Fourier Transformation (F6) in Head Downward 30° - Eyes Closed
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 7, 2017
End Date
September 21, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ertan Sahinoglu

Principal Investigator

Dokuz Eylul University

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

Outcomes

Primary Outcomes

Postural Control-Fourier Transformation (F6) in Head Downward 30° - Eyes Closed

Time Frame: 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-Stability Index in Solid Surface - Eyes Closed

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Closed

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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-Stability Index in Solid Surface - Eyes Open

Time Frame: 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

Time Frame: 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

Time Frame: 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 Standing on Pillows - Eyes Open

Time Frame: 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

Time Frame: 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

Time Frame: 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-Stability Index in Head Raised Backward 30° - Eyes Closed

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Closed

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Postural Control-Weight Distribution Index in Standing on Pillows - Eyes Open

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • Change of Quality of Life(Before treatment and 6 weeks (end treatment))
  • Functional Limitations(Before treatment and 6 weeks (end treatment))
  • Change of Pain(Before treatment and 6 weeks (end treatment))
  • Cognitive State(Only before treatment)

Study Sites (1)

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