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临床试验/NCT04257409
NCT04257409Unknown不适用

Musculoskeletal Changes Induced by Physiotherapeutic Intervention, and Their Impact on the Induction of Diabetic Foot Syndrome and Psychosocial Status in Type 2 Diabetes Mellitus

Mgr. Eliška Vrátná2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Biomechanics- changes of foot joint angles

研究概览

简要总结

The recurrence of diabetic foot ulcers (DFU) is a key problem in podiatric care. It is very often given by biomechanical abnormalities frequently present in those patients. The aim of our randomized controlled study is to find possible changes as of plantar pressures as of biomechanics of the ankle and small joints in patients with type 2 diabetes mellitus with different degrees of neuropathy. During this project, investigators will examine the possible impact of 12-week lasting intervention program on the distribution of plantar pressures, joint mobility and muscle strength of lower limbs. The incidence of ulcerations / reulcerations and changes of psychosocial characteristics will be evaluated during the study period.

Approximately 60 patients with Type 2 diabetes mellitus will be included into the study. These patients will be randomized into 3 study groups - patients with type 2 DM with mild form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20 subjects). All patients will undergo 12 week lasting active intervention program consisting of recommendations by a physiotherapist focusing on the improvement of physical fitness, muscle strength and foot joint improvement. Control group will be consisted of 20 patients with healed diabetic foot.

The outcomes of this project will try to objectively verify in the randomized controlled trial the impact of exercise on lower limb biomechanics, mobility, self-sufficiency, quality of life in patients with type 2 diabetes mellitus at risk or already developed diabetic foot syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

randomization of diabetic patients with healed diabetic foot according the randomization scheme

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes mellitus
  • sensoric neuropathy (mild - based on VPV 15-30 V or EMG results, severe - based on VPT above 50 V or EMG results)
  • diabetic foot with healed diabetic foot ulcers, inactive Charcot foot

排除标准

  • impossibility to exercise
  • amaurosis
  • non-compliance
  • critical limb ischemia
  • active ulcer, surgical wound
  • active Charcot foot
  • active carcinoma
  • recent stroke (last 8 weeks)
  • recent myocardial infarction (last 8 weeks)
  • recent PTA, PCI, bypass (last 8 weeks)
  • rheumatoid arthritis
  • cox-, gonartrosis of 3rd -4th grade.

结局指标

主要结局

Biomechanics- changes of foot joint angles

时间窗: changes after 12 weeks, 24 weeks

changes of foot joint agles will be evaluated by measurement of X-Rays bones angles - calcaneal pitch, talar-1st metatarsal angle and lateral Talocalcaneal angle

Biomechanics- plantar pressures

时间窗: changes after 12 weeks, 24 weeks

plantar pressures will be evaluated by pedobarograph (in Newtons)

Fitness - senior fitness

时间窗: changes after 12 weeks, 24 weeks

fitness will be assessed by seniorfittest containing 2 minutes step test (steps/2 min) and test of sitting (sits/30 seconds)

Biomechanics- biomechanics of the ankle

时间窗: changes after 12 weeks, 24 weeks

biomechanics of the ankle will be assessed by goniometry in angles

Fitness - physical activity

时间窗: changes after 12 weeks, 24 weeks

The amount of physical activity will be assessed by IPAQ questioners

Fitness - muscle strength

时间窗: changes after 12 weeks, 24 weeks

Muscle strength will be measured by dynamometry in Newtons

次要结局

  • Metabolism - glucose control(changes after 12 weeks, 24 weeks)
  • Metabolism - myokines(changes after 12 weeks, 24 weeks)
  • ulceration/reulceration(changes after 12 weeks, 24 weeks)
  • Psychosocial changes - quality of life(changes after 12 weeks, 24 weeks)
  • Psychosocial changes - depression(changes after 12 weeks, 24 weeks)
  • Metabolism - lipid profile(changes after 12 weeks, 24 weeks)
  • Psychosocial changes - stress readaptation(changes after 12 weeks, 24 weeks)

研究者

发起方
Mgr. Eliška Vrátná
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mgr. Eliška Vrátná

Faculty of Physical Education and Sport

Charles University, Czech Republic

研究点 (2)

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