ShoulderNCT07917689
Device-Assisted Balance Training for People With Shoulder Impingement
A study testing Balance exercise protocol and Conventional exercise protocol in people with Shoulder, run by Istanbul Gedik University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study will examine whether adding device-assisted balance training to conventional physiotherapy improves symptoms related to increased pain sensitivity, shoulder pain, shoulder function, and balance in adults with subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder
- What is being tested?
- Balance exercise protocol and Conventional exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Diagnosis of unilateral subacromial impingement syndrome.
Who cannot join
- History of trauma or surgery within the past six months.
- Physiotherapy within the past six months.
- Intra-articular injection within the past six months.
- Cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Emsey Hospital
Istanbul
Nur Begüm Gül, MD, +905362096276, nurbegum.gul@gmail.com
About this study
Official title: The Effect of Balance Training on Central Sensitization and Clinical Outcomes in Patients With Subacromial Impingement Syndrome: A Single-Blinded Randomized Controlled Trial
This randomized controlled study will examine whether adding device-assisted balance training to conventional physiotherapy improves symptoms related to increased pain sensitivity, shoulder pain, shoulder function, and balance in adults with subacromial impingement syndrome. A total of 78 participants will be randomly assigned to receive either balance training plus conventional physiotherapy or conventional physiotherapy alone for six weeks. Assessments will be performed before and after treatment by an assessor who is unaware of group allocation.
Read the detailed description
This assessor-blinded, two-arm randomized controlled trial compares device-assisted balance training added to conventional physiotherapy with conventional physiotherapy alone in adults with unilateral subacromial impingement syndrome. The treatment period is six weeks. The primary outcome is the change in Central Sensitization Inventory. Secondary outcomes include shoulder pain and disability, fear of movement, pressure pain thresholds, and static and dynamic balance. Outcomes are assessed at baseline and immediately after treatment.
- Conditions
- Shoulder
- Being tested
- Balance exercise protocol, Conventional exercise protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exercise protocolOther
Participants receive balance exercises using a BOBO balance board combined with upper-limb movements, in addition to conventional physiotherapy, for six weeks.
Conventional exercise protocolOther
Participants receive conventional physiotherapy consisting of shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Balance exercise protocol | Experimental | Participants receive BOBO device-assisted balance exercises combined with upper-limb movements in addition to conventional physiotherapy for six weeks. Conventional physiotherapy includes shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician. Receives: Other: Balance exercise protocol; Other: Conventional exercise protocol |
| Conventional exercise protocol | Active comparator | Participants receive conventional physiotherapy alone for six weeks, including shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician. Receives: Other: Conventional exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Sensitization Inventory (CSI)
The Central Sensitization Inventory Part A is a 25-item questionnaire assessing symptoms associated with central sensitization. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity. Change from baseline to the end of the six-week treatment period will be evaluated.
Measured: Baseline and immediately after the six-week treatment period.
Secondary outcomes (7)
Change in Shoulder Pain and Disability Index (SPADI) Total Score
The SPADI is a 13-item questionnaire assessing shoulder pain and disability. The total score ranges from 0 to 100, with higher scores indicating greater pain and disability. Change from baseline to the end of treatment will be evaluated.
Measured: Baseline and immediately after the six-week treatment period.
Change in Shoulder Pain
Shoulder pain is assessed using a 10-cm Visual Analog Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Baseline and immediately after the six-week treatment period.
Change in Tampa Scale for Kinesiophobia Score
The 17-item Tampa Scale for Kinesiophobia assesses fear of movement and reinjury. Total scores range from 17 to 68, with higher scores indicating greater kinesiophobia.
Measured: Baseline and immediately after the six-week treatment period.
Change in Pressure Pain Threshold
Pressure pain threshold is assessed using a manual algometer at the deltoid, upper trapezius, supraspinatus, and infraspinatus muscles. Pressure is gradually increased until the participant first reports pain. Three measurements are obtained at each site with 30-second rest intervals. Each measurement site is evaluated separately. Higher thresholds indicate lower pressure pain sensitivity.
Measured: Baseline and immediately after the six-week treatment period.
Change in Y Balance Test Performance
Dynamic balance is assessed using the lower-quarter Y Balance Test in the anterior, posteromedial, and posterolateral directions. Three trials are performed in each direction. Mean reach distances are normalized to limb length and expressed as percentages. The composite score is calculated as the sum of the three directional mean reach distances divided by three times limb length, multiplied by 100. Higher scores indicate better performance.
Measured: Baseline and immediately after the six-week treatment period.
Change in BOBO Balance Scores
Static balance is assessed using the BOBO balance board during a 20-second single-leg stance task. Participants maintain an on-screen indicator within a target area. Three trials are performed, and the highest score is recorded. Scores range from 0 to 100%, with higher scores indicating better performance. Dynamic balance is assessed using the BOBO balance board during a 20-second single-leg task. Participants control an on-screen indicator to follow a target moving in a figure-eight pattern. Three trials are performed, and the highest score is recorded. Scores range from 0 to 100%, with higher scores indicating better performance.
Measured: Baseline and immediately after the six-week treatment period.
Change in Single-Leg Stance Time
Static balance is assessed by measuring the duration of unsupported single-leg stance, up to a maximum of 30 seconds. Longer stance times indicate better balance.
Measured: Baseline and immediately after the six-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start24 Jun 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ShoulderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Gedik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amine Ataç, Istanbul Gedik University
- Investigators
- Amine Ataç, Principal investigator, Istanbul Gedik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917689
- Sponsor's protocol ID
- E-10840098-50.04-3813
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tunca Yılmaz Ö, Yakut Y, Uygur F, Uluğ N. Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon. 2011;22(1):44-49.
Bicer A, Ankarali H. Shoulder pain and disability index: a validation study in Turkish women. Singapore Med J. 2010 Nov;51(11):865-70.
PubMed 21140113Bumin G, Tüzün EH, Tonga E. The Shoulder Pain and Disability Index (SPADI): Cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2008;21(1):57-62. doi:10.3233/BMR-2008-21108.
Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
PubMed 35382371
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Balance Training on Central Sensitization and Clinical Outcomes in Patients With Subacromial Impingement Syndrome: A Single-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07917689
- Acronym / sponsor ID
- E-10840098-50.04-3813
- Conditions
- Shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Istanbul Gedik UniversityUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled study will examine whether adding device-assisted balance training to conventional physiotherapy improves symptoms related to increased pain sensitivity, shoulder pain, shoulder function, and balance in adults with subacromial impingement syndrome. A total of 78 participants will be randomly assigned to receive either balance training plus conventional physiotherapy or conventional physiotherapy alone for six weeks. Assessments will be performed before and after treatment by an assessor who is unaware of group allocation.
Detailed description
This assessor-blinded, two-arm randomized controlled trial compares device-assisted balance training added to conventional physiotherapy with conventional physiotherapy alone in adults with unilateral subacromial impingement syndrome. The treatment period is six weeks. The primary outcome is the change in Central Sensitization Inventory. Secondary outcomes include shoulder pain and disability, fear of movement, pressure pain thresholds, and static and dynamic balance. Outcomes are assessed at baseline and immediately after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance exercise protocol | Experimental | Other: Balance exercise protocol, Other: Conventional exercise protocolParticipants receive BOBO device-assisted balance exercises combined with upper-limb movements in addition to conventional physiotherapy for six weeks. Conventional physiotherapy includes shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician. |
| Conventional exercise protocol | Active comparator | Other: Conventional exercise protocolParticipants receive conventional physiotherapy alone for six weeks, including shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 80 years.
- Diagnosis of unilateral subacromial impingement syndrome.
Key exclusion criteria (4 listed)
- History of trauma or surgery within the past six months.
- Physiotherapy within the past six months.
- Intra-articular injection within the past six months.
- Cognitive impairment.
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 |
|---|---|---|
| Balance exercise protocolParticipants receive balance exercises using a BOBO balance board combined with upper-limb movements, in addition to conventional physiotherapy, for six weeks. | Other | Balance exercise protocol |
| Conventional exercise protocolParticipants receive conventional physiotherapy consisting of shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician for six weeks. | Other | Balance exercise protocol, Conventional exercise protocol |
Primary outcome
Change in Central Sensitization Inventory (CSI)
Time frame: Baseline and immediately after the six-week treatment period.
The Central Sensitization Inventory Part A is a 25-item questionnaire assessing symptoms associated with central sensitization. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity. Change from baseline to the end of the six-week treatment period will be evaluated.
7 secondary outcomes
Change in Shoulder Pain and Disability Index (SPADI) Total Score
Time frame: Baseline and immediately after the six-week treatment period.
Change in Shoulder Pain
Time frame: Baseline and immediately after the six-week treatment period.
Change in Tampa Scale for Kinesiophobia Score
Time frame: Baseline and immediately after the six-week treatment period.
Change in Pressure Pain Threshold
Time frame: Baseline and immediately after the six-week treatment period.
Change in Y Balance Test Performance
Time frame: Baseline and immediately after the six-week treatment period.
Change in BOBO Balance Scores
Time frame: Baseline and immediately after the six-week treatment period.
Change in Single-Leg Stance Time
Time frame: Baseline and immediately after the six-week treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BackgroundTunca Yılmaz Ö, Yakut Y, Uygur F, Uluğ N. Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon. 2011;22(1):44-49.
- Background: PubMed 21140113Bicer A, Ankarali H. Shoulder pain and disability index: a validation study in Turkish women. Singapore Med J. 2010 Nov;51(11):865-70.
- BackgroundBumin G, Tüzün EH, Tonga E. The Shoulder Pain and Disability Index (SPADI): Cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2008;21(1):57-62. doi:10.3233/BMR-2008-21108.
- Background: PubMed 35382371Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
- Individual participant dataSharing planned: Undecided
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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.
Amine Ataç principal investigator
Istanbul Gedik University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance exercise protocol and Conventional exercise protocol in people with Shoulder, run by Istanbul Gedik 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 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nur Begüm Gül, MD (+905362096276, nurbegum.gul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Central Sensitization Inventory (CSI) (time frame: Baseline and immediately after the six-week treatment period.). 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 NCT07917689, which also lists 4 linked publications.
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 4 Nov 2026.