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Набор скоро начнётся NCT07100301

Effect of an Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy

Без фазы С лечением Diabetic Peripheral Neuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Proximal/distal protocol, Distal protocol.
Кому может быть актуально
Состояния в реестре: Diabetic Peripheral Neuropathy. Базовые параметры: 45 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

Effect of a Trunk, Hip, Knee, and Ankle Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy: a Randomized Clinical Trial

Обзор

Diabetic Peripheral Neuropathy (DPN) affects approximately half of people with Diabetes Mellitus (DM). Its repercussions on the musculoskeletal system and biomechanics mainly impact balance and locomotor function. Therefore, this study is justified by the need to design effective treatment alternatives for the motor alterations observed in people with DPN. The objective of this study will be to evaluate the effectiveness of an exercise program for the trunk, hip, knee and ankle, consisting of muscle strengthening and sensorimotor training, in the treatment of motor deficits caused by DPN. This will be a single-blind randomized clinical trial in which 64 individuals with type 2 DM and DPN will be randomly distributed between the experimental and control groups. The primary outcome will be the kinematic analysis of gait. The secondary outcomes will be: muscle strength assessed by dynamometry and the 30-second sit-to-stand test (30STS), and functional mobility through the Timed Up and Go (TUG) test. Assessments will be performed before the start of the intervention, at the end of the intervention, and at the one-month follow-up. The experimental group will perform a 12-week proximal/distal exercise program (trunk, hip, knee, and ankle). The control group will perform a distal exercise program (ankle and foot). The proposed exercise program is expected to show consistently positive results compared to the control group.

Вмешательства

  • Другое Proximal/distal protocol
    Proximal/distal exercise program (trunk, hip, knee and ankle) consisting of four stages: warm-up, strengthening, sensorimotor training and relaxation. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.
  • Другое Distal protocol
    Distal exercise program available in the literature and previously tested. This will contain warm-up exercises, intrinsic foot muscle strengthening, extrinsic foot-ankle muscle strengthening, and functional exercises. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.

Первичные конечные точки

  • Gait speed [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
Вторичные конечные точки (4)
  • Joint angles during gait [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
  • Step length and stride [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
  • Muscle strength [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
  • 30 second sit to stand test [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]

Критерии участия

Критерии включения

  • Adult individuals aged between 45 and 75 years, male or female, diagnosed with DM2
  • DPN diagnosis based on vibration sensitivity tests assessed by a 128 Hz tuning fork and tactile sensitivity measured by a 10 g monofilament
  • Sedentary or irregularly active individuals (level A) according to the Physical Activity Level Classification - IPAQ
  • Score of at least 5 points on the Functional Independence Measure (FIM), i.e., requires supervision, but without physical contact
  • Absence of diabetic foot ulcer (DFU) for at least one month
  • No amputation or at most amputation of fingers, except for the hallux

Критерии исключения

  • Individuals involved in physical training programs simultaneously with the intervention
  • History of surgical intervention in the lower limbs or spine
  • Use of walking assistance devices
  • Diagnosis of severe cardiovascular disorder
  • Diagnosis of other neurological impairments in addition to DPN
  • Presence of dementia or inability to provide consistent information
  • Severe retinopathy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07100301 · 79226724.9.0000.0192

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗