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临床试验/CTRI/2021/11/038201
CTRI/2021/11/038201已完成不适用

EFFECT OF BALANCE ENHANCED EXERCISE PROGRAM (BEEP) ON BALANCE, BALANCE CONFIDENCE, AND NERVE CONDUCTION IN PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY: A RANDOMIZED CONTROL TRIAL.

Sharvari Samant1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年11月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Balance by using Balance Master

研究概览

简要总结

Diabetes negatively affects the peripheral nervefunction leading to postural instability by altering the balance. The BalanceEnhanced Exercise Program (BEEP) protocol emphasizes on all the systemsaffected in diabetic peripheral neuropathy (DPN) patients - musculoskeletal,somatosensory, vestibular. Since, implementing thisprotocol on older adults have shown effect, there is a need to study the effectof BEEP on balance, balance confidence and nerve conduction in patients withDPN.

AIM:Tostudy the effect of balance enhanced exercise program (BEEP) on balance,balance confidence and nerve conduction in patients with diabetic peripheralneuropathy, with the objectivetostudy the effect of BEEP on balance using balance master (LOS & CTSIB), onbalance confidence using Activities-Specific Balance Confidence (ABC) Scale,and nerve conduction velocity using Nerve conduction velocity study.

NULL HYPOTHESIS: Balance enhanced exercise program (BEEP) doesnot have an effect on balance,balance confidenceand nerve conduction in patientswith diabetic peripheral neuropathy.

ALTERNATIVE HYPOTHESIS: Balance enhanced exercise program (BEEP) has an effect on balance, balanceconfidence and nerve conduction in patients with diabetic peripheral neuropathy.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Type II Diabetes Mellitus Berg Balance Scale Score [21-50] Michigan Diabetic Neuropathy Screening Instrument.

排除标准

  • Diabetic ulcers in either foot Other neurological impairments affecting balance (ataxia, Parkinson’s disease etc. except peripheral neuropathy) Severe lower limb, spinal injury or deformity which makes the patient unable to exercise. Patient with cardiac abnormality with an ejection fraction of <30% Pain in the lower extremities, lower back, lumbar radiculopathy etc.

结局指标

主要结局

Balance by using Balance Master

时间窗: 3 weeks intervention

Activities Specific Balance Confidence Scale (ABC)

时间窗: 3 weeks intervention

Nerve Conduction Velocity (NCV)

时间窗: 3 weeks intervention

次要结局

  • SF 36 Questionnaire for quality of life(3 weeks intervention)

研究者

发起方
Sharvari Samant
申办方类型
Other [self]

研究点 (1)

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