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Completed

NCT Number: NCT03054129

Efficacy of Balance Training in Patients With Rotator Cuff Disease

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

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Key information

Conditions

Rotator Cuff Injury Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation and balance training

Other

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

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

Secondary outcomes

  1. Change of Quality of Life

    Time frame: Before treatment and 6 weeks (end treatment)

    Change of Western Ontario Rotator Cuff Index score Total score range 0 (worst) to 2,100 (best).

  2. Functional Limitations

    Time frame: 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.

  3. Change of Pain

    Time frame: Before treatment and 6 weeks (end treatment)

    Change of numeric rating scale score (activity, rest and night) 0 = no pain, 10 = worst possible pain

  4. Cognitive State

    Time frame: Only before treatment

    Cognitive functioning of patients assessed by Mini Mental State Examination Score range 0 (worst) to 30 (best).

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2017
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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