跳至主要内容
临床试验/CTRI/2023/01/049324
CTRI/2023/01/049324尚未招募2 期

Effectiveness of Neuromuscular Taping on Balance, Proprioception, Pain andNerve Conduction parameters in patients with Diabetic Peripheral Neuropathy

KANIKA1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月2日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1. Berg Balance Scale (BBS)

研究概览

简要总结

Diabetic Peripheral Neuropathy (DPN) is defined as “the presence of symptoms or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. 60-70% of diabetic population experience mild to severe damage to nervous system which leads to DPN which usually involves distal body parts and is characterised as distal symmetrical sensorimotor neuropathy which is progressive in nature and follows a "glove and stocking pattern". DPN is found to be more associated with Type 1 diabetes mellitus (DM) (90-95%) compared to Type 1 DM. Interaction of metabolic and vascular factors are responsible for peripheral neuropathy. Physiotherapy has been an option for the management of  DPN. There is plenty of literature available in treating DPN using various physiotherapeutic approach but there is scarcity of literature stating the effects of Neuromuscular Taping (NMT) for the management of DPN. NMT has emerged as an effective approach to treat musculoskeletal and neurological conditions but this concept has never been explored to treat balance, proprioception, pain and nerve conduction parameters in patients with DPN, thereby, making it the real need of time to explore.

研究设计

研究类型
Interventional
分配方式
Stratified randomization
盲法
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

  • Referred cases of Type 1 & Type 2 diabetes mellitus induced diabetic peripheral neuropathy of lower limbs diagnosed by physician and score more than 2/13 on MNSI physical appearance section and scored greater than 1/10 on physical examination of Michigan neuropathy screening instrument (MNSI)
  • Diabetes duration: ≥5 years
  • Age between 40 to 70 years 4.Chronic symmetric sensorimotor involvement of bilateral lower limb after excluding all other causes of peripheral neuropathies
  • Leeds Assessment of Neuropathic Symptoms Scale (LANSS) score > 12 6.Berg Balance Scale (BBS)<45
  • HbA1C report ≥6% not older than 3 months
  • Willing to participate
  • BMI <30kg/m2 (According to Asian criterion).

排除标准

  • Allergic to tape
  • Any other diagnosed neuromuscular disease
  • Vestibular system dysfunction in the last one year (complaint of dizziness, vertigo, nausea and loss of balance) 4.Diabetic foot ulcers, neuropathic joint, charcot joint
  • History of any recent injury (soft tissue and bony) in lower limb six months prior to participation in study
  • Patients with rheumatoid arthritis
  • Patients with varicose veins
  • Any other cause of balance and gait disturbance
  • Deformities of lower limb 10.

结局指标

主要结局

1. Berg Balance Scale (BBS)

时间窗: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument

2. Pedalo®-Sensamove Balance Test Pro with Miniboard

时间窗: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument

3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale

时间窗: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument

4.Nerve Conduction Velocity (NCV)

时间窗: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument

5. Michigan Neuropathy Screening Instrument

时间窗: 1. Berg Balance Scale (BBS) | 2. Pedalo®-Sensamove Balance Test Pro with Miniboard | 3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale | 4.Nerve Conduction Velocity (NCV) | 5. Michigan Neuropathy Screening Instrument

次要结局

  • NA(NA)

研究者

发起方
KANIKA
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验