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临床试验/NCT05250999
NCT05250999已完成不适用

Comparative Effects of Skin Stretch Sensory Stimuli and Transcutaneous Electrical Nerve Stimulation on Balance in Patients With Diabetic Neuropathy

Riphah International University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Berg Balance Scale

研究概览

简要总结

The aim of the research was to find and compare the effects of skin stretch sensory stimuli and transcutaneous electrical nerve stimulation (TENS) on balance in diabetic neuropathy. Randomized controlled trial done at District Headquarter hospital Okara. The sample size was 46. The subjects were divided into 3 groups, 15 subjects in skin stretch sensory stimuli group, 15 subjects in TENS group and 16 subjects in control group. Study duration was of 6 month. Sampling technique applied was convenient non-probability sampling. Patients aged range from 45 to 80 years, having moderate peripheral neuropathy, and decrease sensations were included. Tools used in this study were Berg Balance scale and Toronto clinical neuropathy score system. Data was being analyzed through Spss 21.

详细描述

Literature shows that various studies was done on diabetic patients for pain reduction, increase proprioception, improve muscle function and muscle recruitment by using kinesio tape and transcutaneous electrical nerve stimulation. There is particularly limited literature available on the effects of skin stretch sensory stimuli on balance in DN patients. Therefore, based on the literature study, there is crucial need for studying the effects of skin stretch sensory stimuli and TENS as a treatment approach. Thus, the current study will be an attempt to know the results of skin stretch sensory stimuli and TENS in DN patients.

研究设计

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

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants age ranged from 45 to 80 years' old
  • Both genders.
  • patients with moderate peripheral neuropathy 9-11 on Toronto Clinical Neuropathy Scoring system
  • HbA1c levels
  • peripheral neuropathic pain of >6 months' duration involving the lower extremities
  • history of diabetes treated with diet, oral hypoglycemic or insulin therapy
  • lower extremity symptoms such as muscle pain, decrease in sensations, Achilles tendon reflex, joint position sense of thumb
  • Sensory polyneuropathy because of type 2 diabetic diseases
  • Ability to walk household distance without assistance or with the use of assistive device such as cane.

排除标准

  • Considerable musculoskeletal deformity such as fracture, amputation, abnormality of ROM.
  • Previous history of knee or back surgery
  • Lower extremity arthritis that prevents standing
  • History of cardiovascular problems such as angina, MI
  • Symptomatic postural hypotension
  • Foot ulceration.
  • Skin problems such as rashes etc.

结局指标

主要结局

Berg Balance Scale

时间窗: 6th week

Berg balance scale is used to quantitively evaluate functional balance in older patients with balance disorders. It is a reliable, valid and sensitive to change scale, that include 14 items, maximum score 56 and required 20-40 minutes for completion. The score showed the patient's ability to control postural balance in which maximum score showed a good functional balance.

Toronto Clinical Neuropathy scoring system

时间窗: 6th week

TCNS is a sensitive scoring system to diagnose diabetic neuropathy. The Toronto Clinical Neuropathy Score (TCNS) is for the diagnosis and staging of diabetic neuropathy. The score ranges from a minimum of 0 (no neuropathy) to a maximum of 19 points, and incorporates sensory and motor symptoms, as well lower limb sensory and reflex findings, and symptoms such as numbness, tingling, pain, weakness, ataxia and upper limb symptoms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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