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临床试验/NCT03359772
NCT03359772已完成不适用

Effectiveness of Balance Training With Kinesthetic Ability Trainer-KAT2000 in Patients With Peripheral Neuropathic Pain: a Randomized Controlled Study

Ufuk University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Douleur Neuropathique 4

研究概览

简要总结

Objective: To determine the effectiveness of balance training with Kinesthetic Ability Trainer 2000 (KAT 2000) in patients with peripheral neuropathic pain related balance disorder.

Methods: A total of 60 patients who developed peripheral neuropathic pain-related balance impairment in the chronic phase due to lumber disc herniation, lumber spondylosis and gonarthrosis were included into this randomized controlled prospective study and randomized into either balance exercises groups or KAT 2000 exercises groups. Balance exercises were given all patients in Group 1 (n=30). In addition to balance exercises, KAT 2000 balance exercises were given all patients in group 2 (n=30). All patients received 45-min individualized training session for three times a week for 4 weeks. Patients were evaluated according to pain, static and dynamic balance and quality of life (QoL).

详细描述

Neuropathic pain was determined by the Douleur Neuropathique 4 (DN4) questionnaire. Pain severity was assessed by using a visual analogue scale (VAS). KAT 2000 was used to evaluate static and dynamic balance. Dynamic balance and mobility also was assessed using the Berg Balance Scale (BBS) and Time Up and Go (TUG) test. QoL was assessed by using Nottingham Health Profile (NHP). Patients were evaluated at baseline and the end of the 4-week exercise program.

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
Double (Participant, Investigator)

入排标准

年龄范围
64 Years 至 87 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DN4 scores ≥4 and moderately impaired balance with a score of 21-40 points on the Berg Balance Scale.

排除标准

  • Who had history of previous cerebrovascular events; other neurological, musculoskeletal, inner ear or eye disease that may lead to impaired vision or standing balance.

研究组 & 干预措施

Group 1

No Intervention

Exercise Only Group

Group 2

Active Comparator

Kinesthetic Ability Trainer Group

干预措施: Kinesthetic Ability Trainer (Other)

结局指标

主要结局

Douleur Neuropathique 4

时间窗: 1 months

Neuropathic pain questionnaire, if Douleur Neuropathique 4 value is 4 of more, there is neuropathic pain

次要结局

  • visual analogue scale(1 months)
  • Time Up and Go Test(1 months)
  • Berg Balance Scale(1 months)
  • Nottingham Health Profile(1 months)

研究者

发起方
Ufuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ASLIHAN UZUNKULAOGLU

Ufuk University

Ufuk University

研究点 (2)

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