Efficacy of Balance Training in Patients With Rotator Cuff Disease

NCT03054129 | Completed Results

• 1 other identifier: 2110-GOA
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotator Cuff Injury

Outcome Measures

Primary Outcomes (33)

• 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 Outcomes (4)

• 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 Arms (2)

Rehabilitation and balance training

EXPERIMENTAL

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

Rehabilitation program

ACTIVE COMPARATOR

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

Interventions

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 and balance training

Rehabilitation program OTHER

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

Rehabilitation program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Ertan Şahinoğlu, PT, PhD
• Organization: Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

ertan.sahinoglu@hotmail.com

+90 5326478653

Study Officials

• Ertan ŞAHİNOĞLU, MSc

  Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

  PRINCIPAL INVESTIGATOR

• Bayram ÜNVER, PhD

  Dokuz Eylul University, School of Physical Therapy and Rehabilitation

  STUDY DIRECTOR

• Serkan ERKUŞ, MD

  Tepecik Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Kamil Yamak, MD

  University of Health Sciences, İzmir Bozyaka Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: June 7, 2017
• Primary Completion: August 6, 2019
• Study Completion: September 21, 2019
• Last Updated: December 7, 2023
• Results First Posted: December 7, 2023

Record last verified: 2023-03

Locations

TU (1)