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临床试验/CTRI/2025/06/089393
CTRI/2025/06/089393尚未招募3 期

Comparison of Lagos Neuropathy Protocol, Proprioceptive Neuromuscular Facilitation and Neuromuscular Taping on Sensorimotor Functions in Diabetic Peripheral Neuropathy

Adarsh1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年7月7日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
LANSS Pain Scale

研究概览

简要总结

Introduction: The management of diabetic peripheral neuropathy (DPN) consists of multidirectional interventions. Physiotherapy, in addition to the pharmacological approach, has achieved appreciable popularity in ameliorating the symptoms of DPN. Lagos neuropathy protocol (LNP), proprioceptive neuromuscular facilitation (PNF), and neuromuscular taping (NMT), have shown remarkable improvements in sensorimotor impairments in various neuromuscular and musculoskeletal disorders. Still, no research has been established to compare the effectiveness of LNP, PNF and NMT on sensorimotor functions in individuals with DPN.

Aim: To compare the effectiveness of LNP, PNF and NMT on sensorimotor functions in patients with diabetic peripheral neuropathy.

Materials and Methods: 60 DPN subjects 60-75 years of age both male and female will be divided into 3 groups, scored more than 2/13 on physical appearance and more than 1/10 on physical examination of the Michigan Neuropathy Screening Instrument (MNSI), less than 45 on Berg Balance Scale (BBS) and more than 12 on Leeds Assessment of Neuropathic Symptom and Sign (LANSS) scale) will be included in the study. All three groups (LNP, PNF, and NMT) will receive an intervention for 3 days/week for 10 weeks respectively. Outcome measures will be assessed at baseline and post-intervention, respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Both males and females 60-75 years of age.
  • Referred cases of type 1 and 2 DM-induced sensory and motor lower extremity DPN.
  • Duration of diabetes above 5 years.
  • HbA1c levels 6.5-10 Patients on insulin or OHA drugs.
  • BMI: 18.5-29.9 Michigan neuropathy screening instrument (MNSI) score 2.
  • BBS score less than 45 LANSS Scale more than 12 Patients provided informed consent.
  • MMSE score more than 24.

排除标准

  • Individuals with any systemic manifestations other than diabetes like stroke, SCI, tuberculosis, etc.
  • Diabetic ulcer in either foot.
  • Significant musculoskeletal disorder of lower limbs (amputation, fracture, strain, sprain), any surgery of lower limbs.
  • Diagnosed psychiatric disorders such as schizophrenia, psychosis etc.
  • Patients having advanced knee OA.

结局指标

主要结局

LANSS Pain Scale

时间窗: LANSS Pain Scale (Baseline and 10th week) | Berg Balance Scale (BBS) (Baseline and 10th week) | Position-Reposition Test (Baseline and 10th week) | Lower Limb Matching Test and Sense of Movement Test (Baseline and 10th week)

Berg Balance Scale (BBS)

时间窗: LANSS Pain Scale (Baseline and 10th week) | Berg Balance Scale (BBS) (Baseline and 10th week) | Position-Reposition Test (Baseline and 10th week) | Lower Limb Matching Test and Sense of Movement Test (Baseline and 10th week)

Position-Reposition Test

时间窗: LANSS Pain Scale (Baseline and 10th week) | Berg Balance Scale (BBS) (Baseline and 10th week) | Position-Reposition Test (Baseline and 10th week) | Lower Limb Matching Test and Sense of Movement Test (Baseline and 10th week)

Lower Limb Matching Test and Sense of Movement Test

时间窗: LANSS Pain Scale (Baseline and 10th week) | Berg Balance Scale (BBS) (Baseline and 10th week) | Position-Reposition Test (Baseline and 10th week) | Lower Limb Matching Test and Sense of Movement Test (Baseline and 10th week)

次要结局

  • Gait On Running Gait Analysis Software(Gait On Running Gait Analysis Software (Baseline, 10 weeks))

研究者

发起方
Adarsh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Adarsh

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU)

研究点 (1)

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