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临床试验/CTRI/2024/07/070767
CTRI/2024/07/070767已完成2 期

Effect of unsupervised home exercises on pain, balance, lower limb strength, and functional activity in patients with diabetes polyneuropathy: a pre-post experimental study.

Nitte Institute of Physiotherapy NITTEDeemed to be university1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
1.Douleur neuropathique en 4 questions (dn4)

研究概览

简要总结

20% to 80% of people with type 2 diabetes mellitus (T2DM) experience diabetic polyneuropathy (DPN), a frequent consequence. Patients with DPN are more likely to experience refractory neuropathic pain, limb weakness in both the upper and lower extremities, unstable walking, diminished physical functioning, and a tendency to develop foot ulcers.

Individuals with diabetes polyneuropathy having restricted mobility may find it difficult to attend physiotherapy clinics due to transportation, cost, time and absenteeism at work. However, these difficulties may be met at home with planned, unsupervised exercise programs.

Gaining insight into how home exercises affect people with diabetic polyneuropathy might provide important information on how well, realistically, and consistently patients can complete their activities.

Evaluating the impact of unsupervised home exercises in persons with diabetic polyneuropathy is crucial, considering the costs associated with physiotherapy clinic visits, transportation, and equipment needs.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Documented diagnosis of acute and subacute diabetic polyneuropathy. 2.Participants with the age range of 40-75 years. 3.Intact sensation in both upper and lower limb 4.Patients with medium to low fall risk 5.Numerical Pain Rating Scale (NPRS) with range of (
  • during work or at rest.

排除标准

  • 1.Individuals with significant cognitive impairment.
  • 2.Non documented diagnosis of diabetic polyneuropathy.
  • 3.Impaired sensation in both upper and lower limb.
  • 4.Individuals with foot ulcers.
  • 5.Individuals who have undergone amputation.

结局指标

主要结局

1.Douleur neuropathique en 4 questions (dn4)

时间窗: At baseline and | after 8 weeks of treatment.

2.Berg balance scale

时间窗: At baseline and | after 8 weeks of treatment.

次要结局

  • 1. Hand Held dynamometer(2. Barthel Index)

研究者

发起方
Nitte Institute of Physiotherapy NITTEDeemed to be university
申办方类型
Other [Nitte Institue Of Physiotherapy]
责任方
Principal Investigator
主要研究者

Riddhi Vinay Godhe

Nitte Institute of physiotherapy NITTE(Deemed to be university)

研究点 (1)

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