Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome

2 listopada 2026 zaktualizowane przez: Kadir Songur, Izmir Democracy University

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

96

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Kadir Songür, Assoc. Prof.
  • Numer telefonu: 05054529231
  • E-mail: kadir.93@gmail.com

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: OTHER
  • Perspektywy czasowe: CROSS_SECTIONAL

Kohorty i interwencje

Grupa / Kohorta
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Center-of-Pressure Sway Area Between Eyes-Open and Eyes-Closed Conditions
Ramy czasowe: 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.
Day 1

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Center-of-Pressure Total Path Length
Ramy czasowe: Day 1

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.
Day 1
Anteroposterior Center-of-Pressure Velocity
Ramy czasowe: Day 1

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.
Day 1
Mediolateral Center-of-Pressure Velocity
Ramy czasowe: Day 1

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.
Day 1
Anteroposterior Stability Index
Ramy czasowe: Day 1

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.
Day 1
Mediolateral Stability Index
Ramy czasowe: Day 1

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.
Day 1
Total Stability Index
Ramy czasowe: Day 1

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.
Day 1
Clinical Symptom Severity and Functional Status
Ramy czasowe: Day 1

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.
Day 1
Median Nerve Electrophysiological Parameters
Ramy czasowe: Day 1

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.
Day 1
Hand Sensory Function
Ramy czasowe: Day 1

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.
Day 1
Handgrip and Pinch Strength
Ramy czasowe: Day 1

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.
Day 1

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Izmir Democracy University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

1 września 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

19 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

6 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026/28

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj