Quality of Life in Hereditary and Inflammatory Peripheral Neuropathies

Официальное название

Cross-sectional Observational Study on the Impact of Neuromuscular Diseases on Quality of Life: Focus on Peripheral Neuropathies (Hereditary vs Inflammatory)

Обзор

Neuromuscular diseases affect the nerves and muscles and can cause weakness, pain, fatigue, and difficulties in daily life. These problems may reduce independence, social participation, and overall quality of life.This observational study aims to evaluate the impact of peripheral neuropathies on quality of life. It focuses on two types of peripheral neuropathies: hereditary neuropathies, caused by genetic factors, and inflammatory neuropathies, caused by immune-related nerve damage. Adult patients with these conditions will be assessed at a single time point, without any change to their usual medical care. Participants will complete questionnaires about daily functioning, well-being, and quality of life. Some questions will also explore the use of assistive devices and supportive tools in everyday life.The study hypothesizes that peripheral neuropathies significantly affect quality of life and that this impact differs between hereditary and inflammatory forms. The results aim to improve understanding of patients' needs and support better, more personalized care."

Вмешательства

• Другое WHODAS 2.0 questionnaire
  WHODAS 2.0: Assesses daily functioning and disability across six domains: understanding, mobility, self-care, interpersonal relationships, domestic activities, and social participation. WHOQOL-BREF: Measures overall quality of life in four domains: physical, psychological, social relationships, and environment. MPT Questionnaire (SOTU and ATD PA): Evaluates participants' attitudes, perceptions, and professional practices in a specific organizational or educational context.

Первичные конечные точки

• Quality of life (WHOQOL-BREF score) [Срок оценки: At the inclusion]

Вторичные конечные точки (7)

• Comparison of perceived quality of life [Срок оценки: At the inclusion]
• Association between functioning and quality of life [Срок оценки: At the inclusion]
• Factors associated with impaired functioning and quality of life [Срок оценки: At the inclusion]
• Role of assistive technologies (MPT) [Срок оценки: At the inclusion]
• Profile of limitations [Срок оценки: At the inclusion]
• Activity restrictions [Срок оценки: At the inclusion]
• Environmental factors [Срок оценки: At the inclusion]

Критерии участия

Критерии включения

• Clinical and paraclinical diagnosis compatible with hereditary or inflammatory peripheral neuropathy, confirmed by the investigating physicians (genetic results for HPN if available; clinical/electrophysiological criteria for IPN).
• Written informed consent.
• Ability to complete the questionnaires (or with the assistance of a caregiver if necessary, specifying the mode of assistance).

Критерии исключения

• Legal incapacity (under guardianship or conservatorship).
• Moderate to severe cognitive impairment (e.g., MMSE < 27) preventing valid comprehension and completion of the questionnaires.
• Active cancer undergoing chemotherapy or radiotherapy (treatment likely to significantly alter quality of life in a non-specific way).
• Other acute serious medical conditions that could interfere with assessment, at the investigator's discretion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• CHU de Nice — Nice

Идентификаторы

NCT: NCT07340749 · 26Neuro01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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