Efficacy of Balance Training in Patients With Rotator Cuff Disease

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

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injury
• Intervention / Treatment: Other: Rehabilitation program; Other: Rehabilitation and balance training

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Other: Rehabilitation program; Rehabilitation program will be same in this group except balance exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Cognitive State	Cognitive functioning of patients assessed by Mini Mental State Examination Score range 0 (worst) to 30 (best).	Only before treatment

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Ertan ŞAHİNOĞLU, MSc, Dr. İsmail Atabek Physical Therapy and Rehabilitation Center; Study Director: Bayram ÜNVER, PhD, Dokuz Eylul University, School of Physical Therapy and Rehabilitation; Principal Investigator: Serkan ERKUŞ, MD, Tepecik Training and Research Hospital; Principal Investigator: Kamil Yamak, MD, University of Health Sciences, İzmir Bozyaka Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): September 21, 2019

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2110-GOA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No