Rotator Cuff InjuryNCT03054129

Efficacy of Balance Training in Patients With Rotator Cuff Disease

A study testing Rehabilitation and balance training and Rehabilitation program in people with Rotator Cuff Injury, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rotator Cuff Injury
What is being tested?: Rehabilitation and balance training and Rehabilitation program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 7 Jun 2017to 21 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

Cardiovascular diseases which affect balance.
Acute dizziness
Medications which affected balance
Subjects who performed balance training

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Conditions: Rotator Cuff Injury
Being tested: Rehabilitation and balance training, Rehabilitation program
Medical subject headings: Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03054129
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment and 6 weeks (end of the treatment)

Secondary outcomes (4)

Change of Quality of Life
Change of Western Ontario Rotator Cuff Index score Total score range 0 (worst) to 2,100 (best).
Measured: 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.
Measured: 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
Measured: 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).
Measured: Only before treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201721 Sep 2019

First posted15 Feb 2017
Study start7 Jun 2017
Primary completion6 Aug 2019
Study completion21 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03054129
Sponsor's protocol ID: 2110-GOA
Status last verified: Mar 2023
First submitted: 13 Feb 2017
Last updated: 7 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
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All Rotator Cuff Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Balance Training in Patients With Rotator Cuff Disease: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03054129
Acronym / sponsor ID: 2110-GOA
Conditions: Rotator Cuff Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Dokuz Eylul UniversityUniversity, hospital or other
Study start: 7 Jun 2017 (actual)
Primary completion: 6 Aug 2019 (actual)
Study completion: 21 Sep 2019 (actual)
First posted: 15 Feb 2017 (actual)
Results: Posted 7 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rehabilitation and balance training	Experimental	Other: Rehabilitation and balance trainingEach 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.
Rehabilitation program	Active comparator	Other: Rehabilitation programEach 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rehabilitation and balance trainingStretching 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.	Other	Rehabilitation and balance training
Rehabilitation programRehabilitation program will be same in this group except balance exercises.	Other	Rehabilitation program

Primary outcome

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 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-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 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-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 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 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 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 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 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 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 (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-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 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 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-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-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-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-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 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 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-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.
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.

4 secondary outcomes

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

Results and safety

Results posted to the registry on 7 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rehabilitation Program	21	19
Rehabilitation and Balance Training	21	20

Primary outcome: Postural Control-Stability Index in Solid Surface - Eyes Open

Time frame: Before treatment and 6 weeks (end of the treatment). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Rehabilitation Program n = 19	Rehabilitation and Balance Training n = 20
Value	1.06 (-0.74 to 3)	2.00 (-1.99 to 3.36)

Rehabilitation Program vs Rehabilitation and Balance Training: p = 0.866, Wilcoxon (Mann-Whitney)

Population analysed: In rehabilitation program group, two patients withdrew from study In rehabilitation and balance training group, one patients excluded from the study due to a sytemic disease diagnosed.

Primary outcome: Postural Control-Stability Index in Solid Surface - Eyes Closed

Time frame: Before treatment and 6 weeks (end of the treatment). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Rehabilitation Program n = 19	Rehabilitation and Balance Training n = 20
Value	0.74 (-2.96 to 3.53)	-2.37 (-5.35 to 3.00)

Rehabilitation Program vs Rehabilitation and Balance Training: p = 0.361, Wilcoxon (Mann-Whitney)

Primary outcome: Postural Control-Stability Index in Standing on Pillows - Eyes Open

Time frame: Before treatment and 6 weeks (end of the treatment). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Rehabilitation Program n = 19	Rehabilitation and Balance Training n = 20
Value	1.40 (-2.66 to 3.15)	0.71 (-1.27 to 4.50)

Rehabilitation Program vs Rehabilitation and Balance Training: p = 0.715, Wilcoxon (Mann-Whitney)

Primary outcome: Postural Control-Stability Index in Standing on Pillows - Eyes Closed

Time frame: Before treatment and 6 weeks (end of the treatment). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Rehabilitation Program n = 19	Rehabilitation and Balance Training n = 20
Value	-0.52 (-3.85 to 2.02)	-0.31 (-8.55 to 8.02)

Rehabilitation Program vs Rehabilitation and Balance Training: p = 0.978, Wilcoxon (Mann-Whitney)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse effects were expected in the study; therefore, it adverse events were not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rehabilitation Program	0 of 0	0 of 0	0
Rehabilitation and Balance Training	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ertan ŞAHİNOĞLU, MSc principal investigator

Dr. İsmail Atabek Physical Therapy and Rehabilitation Center

Bayram ÜNVER, PhD study director

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Serkan ERKUŞ, MD principal investigator

Tepecik Training and Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation and balance training and Rehabilitation program in people with Rotator Cuff Injury, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural Control-Stability Index in Solid Surface - Eyes Open (time frame: Before treatment and 6 weeks (end of the treatment)). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03054129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.