Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome

2 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

96

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Kadir Songür, Assoc. Prof.
  • Número de teléfono: 05054529231
  • Correo electrónico: kadir.93@gmail.com

Ubicaciones de estudio

  • Turquía (Türkiye)
    • İzmir
      • Izmir, İzmir, Turquía (Türkiye), 35570
        • Izmir Democracy University
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: OTHER
  • Perspectivas temporales: CROSS_SECTIONAL

Cohortes e Intervenciones

Grupo / Cohorte
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Center-of-Pressure Sway Area Between Eyes-Open and Eyes-Closed Conditions
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Center-of-Pressure Total Path Length
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Izmir Democracy University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de diciembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Publicado por primera vez (Actual)

6 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026/28

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir