Device-Assisted Balance Training for People With Shoulder Impingement

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder
• Intervention / Treatment: Other: Balance exercise protocol; Other: Conventional exercise protocol

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nur Begüm Gül, MD; Phone Number: +905362096276; Email: nurbegum.gul@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Emsey Hospital
    • Contact: Nur Begüm Gül, MD; Phone Number: +905362096276; Email: nurbegum.gul@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 80 years.
• Diagnosis of unilateral subacromial impingement syndrome.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance exercise protocol; 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.	Other: Balance exercise protocol; Participants receive balance exercises using a BOBO balance board combined with upper-limb movements, in addition to conventional physiotherapy, for six weeks.; Other: Conventional exercise protocol; 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.
Active Comparator: Conventional exercise protocol; 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.	Other: Conventional exercise protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and immediately after the six-week treatment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline and immediately after the six-week treatment period.

Collaborators and Investigators

• Sponsor: Istanbul Gedik University
• Investigators: Principal Investigator: Amine Ataç, Istanbul Gedik University

Publications and helpful links

General Publications

• Bicer A, Ankarali H. Shoulder pain and disability index: a validation study in Turkish women. Singapore Med J. 2010 Nov;51(11):865-70.
• 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.
• 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.
• Bumin 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: October 31, 2026
• First Submitted That Met QC Criteria: October 31, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 31, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: E-10840098-50.04-3813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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