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临床试验/CTRI/2022/06/043564
CTRI/2022/06/043564尚未招募不适用

"Study on the effects of Neural Mobilisation and exercises on Neuromuscular properties in subjects with Diabetic Peripheral Neuropathyâ€

Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Central university2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
2
主要终点
Blood glucose level, Glycosylated haemoglobin (HbA1c),motor and sensory Nerve conduction velocity (tibial and sural nerve),Fatigue of lower limb muscles,TNF-α, NPRS

研究概览

简要总结

NeuralMobilization (NM) techniques are performed to reduce nerve mechano-sensitivityand increase the compliance of nerve tissues by increasing neural flexibility(Schmid et al., 2009). Thetechnique works by improving axonal transport and increasing blood flow byreducing pressure within the nerves (Schmid et al., 2009). The NM techniquesare useful in restoring the normal physiological function through both theintraneural and extra neural effect (Brown et al., 2011; Goyal et al., 2016). Astudy conducted on normal population showed NM increase pain threshold andimprovement in biceps brachii muscle fatigue (M. K. Kim et al., 2016). Endurance isreduced by as much as 45% in type 1 DM and is also related to lowered NCV(Almeida et al., 2008). Astudy conducted to check the feasibilityof NM in DM patients concluded it is safe without any adverse effects (Boyd,Nee, & Smoot, 2017). Although this technique is safe inDM patients, effects of NM as an intervention on various neuromuscularproperties like nerve function, sensorimotor functions and inflammatorybiomarkers in patients with DPN is a place to research. We, therefore, plan this study toexamine the effects of NM plus strengthening exercises in patients with DPN. Inthis study we will screen the patients through MDNS scoring and randomized thepatients into control group, experimental group A and experimental group B. Thecontrol group will receive consultation for usual care and dietary advice. The duration of intervention is 8 weeks. A sample size of 84 will be randomized into the 3 groups. The outcomes measures are Blood glucose level, Glycosylated haemoglobin (HbA1c), motor and sensory Nerve conduction velocity (tibial and sural nerve),Fatigue of lower limb muscles, TNF-α, NPRS.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Subjects diagnosed with diabetes mellitus detected at least 5 years or before the enrolment.
  • •MDNS score ≥ 6 will be included.
  • •Ability to walk independently household distances without assistive device.

排除标准

  • •1.History of neurological symptoms other than that of diabetic peripheral neuropathy (i.e., hemiparesis, myelopathy, cerebellar ataxia, etc.) 2.History of cardiovascular disease (angina, breathlessness, uncontrolled hypertension).
  • •3.Significant musculoskeletal deformity (amputation, scoliosis, severe osteoarthritis).
  • •4.Lower extremity arthritis that limits standing or weight bearing position.
  • •5.Symptomatic postural hypotension (standing up to 5 min).
  • •6.Evidence of vestibular dysfunction.
  • •8.Vascular complications (venous or arterial ulcers) 9.Receiving any physical therapy intervention.

结局指标

主要结局

Blood glucose level, Glycosylated haemoglobin (HbA1c),motor and sensory Nerve conduction velocity (tibial and sural nerve),Fatigue of lower limb muscles,TNF-α, NPRS

时间窗: At baseline (pre-intervention) and at 8 weeks (post-intervention)

次要结局

  • NPRS, Quality of life,(At baseline(pre-intervention) and at 8 weeks (post-intervention))

研究者

发起方
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Central university
申办方类型
Other [Central University]

研究点 (2)

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