Carpal Tunnel Syndrome (CTS)NCT07922356
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS) and Postural Assessment, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate static and dynamic postural control in patients with carpal tunnel syndrome (CTS) according to electrophysiological disease severity and to compare their balance performance with that of healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Postural Assessment, Postural Dysfunction
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adults aged 18-65 years recruited from the Physical Medicine and Rehabilitation Department of İzmir Democracy University, Buca Seyfi Demirsoy Training and Research Hospital, Türkiye. Participants with clinically and electrophysiologically confirmed carpal tunnel syndrome (CTS) will be classified into mild (Bland grades 1-2), moderate (Bland grade 3), and severe (Bland grades 4-6) groups according to electrophysiological findings. A healthy control group consisting of adults without clinical symptoms suggestive of CTS or known disorders affecting postural control will also be included. A total of 96 participants, with 24 individuals in each group, will be enrolled.
Who may be able to join
- For participants with CTS:
- Aged 18-65 years.
- Clinical symptoms consistent with CTS.
- Electrophysiologically confirmed median neuropathy at the wrist.
- CTS severity classifiable according to the Bland grading system.
- Ability to stand independently and complete balance assessments.
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- Provision of written informed consent.
- For healthy controls:
- Aged 18-65 years.
- No clinical symptoms suggestive of CTS.
- No known neurological or musculoskeletal condition affecting postural control.
Who cannot join
- Central neurological disorders affecting balance.
- Vestibular disorders or significant vertigo.
- Diabetes mellitus.
- Polyneuropathy or other peripheral neuropathies affecting balance.
- Cervical radiculopathy or brachial plexopathy.
- Significant lower-extremity neurological or musculoskeletal disorders.
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- Recent lower-extremity surgery or major trauma affecting standing or walking.
- Inability to stand independently.
- Visual impairment affecting balance assessment.
- Use of medications significantly affecting balance.
- Pregnancy.
- Previous surgical decompression for CTS.
- Cognitive or communication impairment preventing compliance with assessment procedures.
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
Izmir Democracy University
Izmir, İzmir, 35570
Kadir Songür, 05054529231, kadir.93@gmail.com
About this study
Official title: Evaluation of Static and Dynamic Postural Control According to Electrophysiological Severity of Carpal Tunnel Syndrome: A Controlled Cross-Sectional Observational Study
This observational study aims to evaluate static and dynamic postural control in patients with carpal tunnel syndrome (CTS) according to electrophysiological disease severity and to compare their balance performance with that of healthy controls.
A total of 96 participants will be recruited into four groups: healthy controls and patients with mild, moderate, or severe CTS classified according to the Bland electrophysiological grading system.
Read more
Postural control will be assessed using the TecnoBody ProKin balance system under eyes-open and eyes-closed conditions. Additional assessments will include nerve conduction parameters, the Boston Carpal Tunnel Questionnaire, sensory function, handgrip strength, and pinch strength.
The primary objective is to determine whether the effect of visual condition on center-of-pressure sway area differs across the four study groups.
Read the detailed description
Carpal tunnel syndrome (CTS) is a common entrapment neuropathy of the median nerve characterized by sensory disturbances, pain, and motor dysfunction. Although its effects on hand sensation and motor performance are well established, the potential relationship between CTS-related sensorimotor impairment and postural control remains insufficiently understood.
Postural stability depends on the integration of visual, vestibular, and somatosensory information. Alterations in somatosensory function associated with CTS may influence postural control, particularly when visual information is unavailable.
This single-center, controlled, cross-sectional observational study will include 96 adults aged 18-65 years, distributed across four groups: healthy controls, mild CTS (Bland grades 1-2), moderate CTS (Bland grade 3), and severe CTS (Bland grades 4-6).
Static postural control will be evaluated using the TecnoBody ProKin system during 30-second bipedal standing trials under eyes-open and eyes-closed conditions. Center-of-pressure parameters, including sway area, total path length, and anteroposterior and mediolateral sway velocity, will be recorded. Dynamic balance will be assessed using standardized platform conditions.
Additional assessments will include median nerve conduction studies, the Boston Carpal Tunnel Questionnaire, Semmes-Weinstein monofilament testing, two-point discrimination, handgrip strength, and pinch strength.
The primary analysis will examine the interaction between study group and visual condition for log-transformed center-of-pressure sway area. Secondary analyses will investigate other posturographic parameters and their relationships with electrophysiological severity, sensory impairment, and clinical function.
- Conditions
- Carpal Tunnel Syndrome (CTS), Postural Assessment, Postural Dysfunction, Balance Assessment, Nerve Conduction Study
- Keywords
- carpal tunnel syndrome, postural assessment, postural dysfunction, balance assessment, balance, nerve conduction study
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Healthy Controls | Adults without clinical symptoms suggestive of CTS | |
| Group 2 - Mild CTS | Electrophysiologically confirmed CTS, Bland grades 1-2 | |
| Group 3 - Moderate CTS | Electrophysiologically confirmed CTS, Bland grade 3 | |
| Group 4 - Severe CTS | Electrophysiologically confirmed CTS, Bland grades 4-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Center-of-Pressure Sway Area Between Eyes-Open and Eyes-Closed Conditions
Center-of-pressure (COP) sway area will be measured in square millimeters (mm²) using the TecnoBody ProKin posturography system during 30-second bipedal static standing assessments under eyes-open and eyes-closed conditions. We will calculate the within-participant difference in log-transformed COP sway area between the two visual conditions. We will compare this difference across four groups: healthy controls and participants with mild, moderate, or severe carpal tunnel syndrome.
Measured: Day 1
Secondary outcomes (10)
Center-of-Pressure Total Path Length
Center-of-pressure (COP) total path length will be measured in millimeters (mm) using the TecnoBody ProKin posturography system during 30-second bipedal static standing assessments under both eyes-open and eyes-closed conditions. Total COP path length represents the cumulative distance traveled by the COP during each assessment. Values obtained under both visual conditions will be recorded separately and compared across healthy controls and mild, moderate, and severe carpal tunnel syndrome groups.
Measured: Day 1
Anteroposterior Center-of-Pressure Velocity
Mean anteroposterior center-of-pressure (COP) velocity will be measured in millimeters per second (mm/s) using the TecnoBody ProKin posturography system during 30-second bipedal static standing assessments under both eyes-open and eyes-closed conditions. This parameter quantifies COP movement velocity along the anteroposterior axis. Values obtained under both visual conditions will be recorded separately and compared across healthy controls and mild, moderate, and severe carpal tunnel syndrome groups.
Measured: Day 1
Mediolateral Center-of-Pressure Velocity
Mean mediolateral center-of-pressure (COP) velocity will be measured in millimeters per second (mm/s) using the TecnoBody ProKin posturography system during 30-second bipedal static standing assessments under both eyes-open and eyes-closed conditions. This parameter quantifies COP movement velocity along the mediolateral axis. Values obtained under both visual conditions will be recorded separately and compared across healthy controls and mild, moderate, and severe carpal tunnel syndrome groups.
Measured: Day 1
Anteroposterior Stability Index
The anteroposterior stability index (APSI) will be measured using the movable platform of the TecnoBody ProKin posturography system during a standardized bipedal dynamic balance assessment. The APSI quantifies postural instability in the anteroposterior direction. Values will be compared across healthy controls and participants with mild, moderate, and severe carpal tunnel syndrome.
Measured: Day 1
Mediolateral Stability Index
The mediolateral stability index (MLSI) will be measured using the movable platform of the TecnoBody ProKin posturography system during a standardized bipedal dynamic balance assessment. The MLSI quantifies postural instability in the mediolateral direction. Values will be compared across healthy controls and participants with mild, moderate, and severe CTS.
Measured: Day 1
Total Stability Index
The total stability index (TSI) will be measured using the movable platform of the TecnoBody ProKin posturography system during a standardized bipedal dynamic balance assessment. The TSI provides an overall measure of dynamic postural instability. Values will be compared across healthy controls and participants with mild, moderate, and severe CTS.
Measured: Day 1
Clinical Symptom Severity and Functional Status
Clinical symptoms and functional impairment will be assessed using the Boston Carpal Tunnel Questionnaire (BCTQ), consisting of the Symptom Severity Scale (BCTQ-SSS; 11 items) and Functional Status Scale (BCTQ-FSS; 8 items). Each item is scored from 1 to 5, and the mean score for each subscale ranges from 1 to 5. Higher scores indicate greater symptom severity or functional impairment. Associations between BCTQ scores and postural control parameters will be evaluated in participants with CTS.
Measured: Day 1
Median Nerve Electrophysiological Parameters
Median nerve function will be assessed using nerve conduction studies. Sensory nerve conduction velocity (m/s), sensory nerve action potential (SNAP) amplitude, distal motor latency (ms), and compound muscle action potential (CMAP) amplitude will be recorded. Electrophysiological CTS severity will be classified according to the Bland grading system. Associations between electrophysiological parameters and postural control measures will be examined in participants with CTS.
Measured: Day 1
Hand Sensory Function
Cutaneous sensory function will be assessed using Semmes-Weinstein monofilament testing and static two-point discrimination. Testing will be performed over the distal pulp of the thumb, index finger, and middle finger. Monofilament testing will determine the lowest reliably perceived mechanical stimulus, while two-point discrimination will measure the minimum distance (mm) at which two simultaneous tactile stimuli can be distinguished. Higher thresholds indicate greater sensory impairment. Associations with postural control parameters will be examined.
Measured: Day 1
Handgrip and Pinch Strength
Handgrip strength will be measured using a hand dynamometer, and pinch strength will be assessed using a hydraulic pinch gauge. Pinch measurements will include tip-to-tip, lateral, and three-point pinch strength. Three measurements will be obtained for each hand, and the mean value will be recorded in kilograms (kg). Associations between hand strength and postural control parameters will be examined in participants with CTS.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Songur, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922356
- Sponsor's protocol ID
- 2026/28
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Static and Dynamic Postural Control According to Electrophysiological Severity of Carpal Tunnel Syndrome: A Controlled Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07922356
- Acronym / sponsor ID
- 2026/28
- Conditions
- Carpal Tunnel Syndrome (CTS), Postural Assessment, Postural Dysfunction, Balance Assessment, Nerve Conduction Study
- Keywords
- carpal tunnel syndrome, postural assessment, postural dysfunction, balance assessment, balance, nerve conduction study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 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 observational study aims to evaluate static and dynamic postural control in patients with carpal tunnel syndrome (CTS) according to electrophysiological disease severity and to compare their balance performance with that of healthy controls.
A total of 96 participants will be recruited into four groups: healthy controls and patients with mild, moderate, or severe CTS classified according to the Bland electrophysiological grading system.
Postural control will be assessed using the TecnoBody ProKin balance system under eyes-open and eyes-closed conditions. Additional assessments will include nerve conduction parameters, the Boston Carpal Tunnel Questionnaire, sensory function, handgrip strength, and pinch strength.
The primary objective is to determine whether the effect of visual condition on center-of-pressure sway area differs across the four study groups.
Detailed description
Carpal tunnel syndrome (CTS) is a common entrapment neuropathy of the median nerve characterized by sensory disturbances, pain, and motor dysfunction. Although its effects on hand sensation and motor performance are well established, the potential relationship between CTS-related sensorimotor impairment and postural control remains insufficiently understood.
Postural stability depends on the integration of visual, vestibular, and somatosensory information. Alterations in somatosensory function associated with CTS may influence postural control, particularly when visual information is unavailable.
This single-center, controlled, cross-sectional observational study will include 96 adults aged 18-65 years, distributed across four groups: healthy controls, mild CTS (Bland grades 1-2), moderate CTS (Bland grade 3), and severe CTS (Bland grades 4-6).
Static postural control will be evaluated using the TecnoBody ProKin system during 30-second bipedal standing trials under eyes-open and eyes-closed conditions. Center-of-pressure parameters, including sway area, total path length, and anteroposterior and mediolateral sway velocity, will be recorded. Dynamic balance will be assessed using standardized platform conditions.
Additional assessments will include median nerve conduction studies, the Boston Carpal Tunnel Questionnaire, Semmes-Weinstein monofilament testing, two-point discrimination, handgrip strength, and pinch strength.
The primary analysis will examine the interaction between study group and visual condition for log-transformed center-of-pressure sway area. Secondary analyses will investigate other posturographic parameters and their relationships with electrophysiological severity, sensory impairment, and clinical function.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Healthy Controls | – | –Adults without clinical symptoms suggestive of CTS |
| Group 2 - Mild CTS | – | –Electrophysiologically confirmed CTS, Bland grades 1-2 |
| Group 3 - Moderate CTS | – | –Electrophysiologically confirmed CTS, Bland grade 3 |
| Group 4 - Severe CTS | – | –Electrophysiologically confirmed CTS, Bland grades 4-6 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18-65 years recruited from the Physical Medicine and Rehabilitation Department of İzmir Democracy University, Buca Seyfi Demirsoy Training and Research Hospital, Türkiye. Participants with clinically and electrophysiologically confirmed carpal tunnel syndrome (CTS) will be classified into mild (Bland grades 1-2), moderate (Bland grade 3), and severe (Bland grades 4-6) groups according to electrophysiological findings. A healthy control group consisting of adults without clinical symptoms suggestive of CTS or known disorders affecting postural control will also be included. A total of 96 participants, with 24 individuals in each group, will be enrolled.
Key inclusion criteria (11 listed)
- Aged 18-65 years.
- Clinical symptoms consistent with CTS.
- Electrophysiologically confirmed median neuropathy at the wrist.
- CTS severity classifiable according to the Bland grading system.
- Ability to stand independently and complete balance assessments.
Key exclusion criteria (13 listed)
- Central neurological disorders affecting balance.
- Vestibular disorders or significant vertigo.
- Diabetes mellitus.
- Polyneuropathy or other peripheral neuropathies affecting balance.
- Cervical radiculopathy or brachial plexopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Center-of-Pressure Sway Area Between Eyes-Open and Eyes-Closed Conditions
Time frame: Day 1
Center-of-pressure (COP) sway area will be measured in square millimeters (mm²) using the TecnoBody ProKin posturography system during 30-second bipedal static standing assessments under eyes-open and eyes-closed conditions. We will calculate the within-participant difference in log-transformed COP sway area between the two visual conditions. We will compare this difference across four groups: healthy controls and participants with mild, moderate, or severe carpal tunnel syndrome.
10 secondary outcomes
Center-of-Pressure Total Path Length
Time frame: Day 1
Anteroposterior Center-of-Pressure Velocity
Time frame: Day 1
Mediolateral Center-of-Pressure Velocity
Time frame: Day 1
Anteroposterior Stability Index
Time frame: Day 1
Mediolateral Stability Index
Time frame: Day 1
Total Stability Index
Time frame: Day 1
Clinical Symptom Severity and Functional Status
Time frame: Day 1
Median Nerve Electrophysiological Parameters
Time frame: Day 1
Hand Sensory Function
Time frame: Day 1
Handgrip and Pinch Strength
Time frame: Day 1
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome (CTS) and Postural Assessment, run by Izmir Democracy 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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 6 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 Kadir Songür, Assoc. Prof. (05054529231, kadir.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Center-of-Pressure Sway Area Between Eyes-Open and Eyes-Closed Conditions (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.