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临床试验/CTRI/2025/07/091743
CTRI/2025/07/091743尚未招募不适用

Effectiveness Of Lee Silverman Voice Treatment (LSVT) BIG In Improving Balance And Gait In Patients With Diabetic Neuropathy In Dervan: A Randomized Controlled Trial

Dr Maansi Patel1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
• Berg Balance Scale (BBS)

研究概览

简要总结

Title - Effectiveness of Lee Silverman Voice Treatment (LSVT) BIG in Improving Balance and Gait in Patients with Diabetic Neuropathy in Dervan: A Randomized Controlled Trial

INTRODUCTION

Approximately 830 million people, worldwide suffer from diabetes, making it a serious health issue. One of its most complications is Diabetic neuropathy, which affects over 50% of people with diabetes. In India, diabetic neuropathy is common, however, its occurrence differs considerably across multiple populations, with estimates ranging from 9.6% to 78%.

Diabetic neuropathy (DN) condition is one of the leading causes of falls in many people with neurological conditions, considerably affecting balance and gait. Lower limb proprioception, cutaneous sensation and muscle stretch reflexes are greatly affected by this condition. These functions are necessary for detecting balance problems and initiating corrective actions. Therefore, such population are at greater risk of balance problems and falls.

The progression of DPN can have a significant impact on a person’s daily life. In the early stages the symptoms may be mild or barely noticeable. But, as the condition advances, people often struggle with sensory and motor impairments affecting their mobility and overall well-being.

Physiotherapy plays an important role in controlling DN by addressing issues like neuropathic pain, muscle weakness, gait instability, and balance issues. Balance issues due to proprioceptive deficiencies and weak ankle muscles are frequently observed. To enhance postural control and coordination, multisensory training, single-leg stance exercises, and weight-shifting drills are observed to be beneficial.

In a randomized clinical trial, Khashayar(2015) compared LSVT BIG with a general exercise program and found significant improvements in balance, gait speed, and postural stability in PD patients. Enhanced weight-shifting ability, increased stride length, and improved reaction times, were also observed all of which are crucial for preventing falls. In conclusion, LSVT BIG therapy proved to be an effective intervention for managing balance deficits in PD, helping individuals reduce fall risk, improve mobility, and maintain independence.

AIM OF THE STUDY-

To evaluate the effectiveness of LSVT BIG in improving balance and gait in patients with diabetic neuropathy.

OBJECTIVE OF THE STUDY –

To compare the effectiveness of LSVT BIG and Conventional Physiotherapy on balance and gait among DN patients.

NEED OF THE STUDY

LSVT BIG is a high-amplitude movement therapy originally developed to improve motor function, balance, and gait. Given the similarities between Parkinsonian gait disturbances and the gait impairments seen in diabetic neuropathy, such as reduced stride length, slow walking speed, and postural instability, LSVT BIG may offer potential benefits for improving motor control and balance in these patients.

Unlike traditional rehabilitation, which often focuses on isolated muscle groups or balance strategies, LSVT BIG encourages whole-body movements that may contribute to improvements in coordination, step length, and walking speed.

This study can prove essential to evaluate whether LSVT BIG exercises can serve as an effective physiotherapy intervention for improving balance and gait in patients with DN. Findings could contribute to clinical guidelines for DN rehabilitation, helping develop targeted interventions to improve patient outcomes.

Inclusion criteria:

Diabetes diagnosed by physician

Age group- 40 to 70 years

Toronto Clinical Scoring System > 6 /19

Walking independently without walking aids

Exclusion criteria:

Foot ulceration/infection/amputation

Severe retinopathy/ Non operated Cataract

Non-neuropathy related orthopedic, surgical or medical conditions

Alcohol abuse

Vestibular dysfunction

METHODOLOGY:

Study design: Experimental Study: RCT

Study population: Diabetic Neuropathy

Study setting: Physiotherapy OPD (Rural Medical Hospital)

Study duration: 18 Months.

Sampling method: Purposive sampling

Allocation concealment method: SNOSE technique

Sample size: A total of 46 subjects will be taken.

Outcome measures:

Berg Balance Scale (BBS)

10-meter walk test (10mWT)

Materials

128 Hz Tuning Fork

Reflex Hammer

Test tubes

Measuring Tape

Chair

Stopwatch

Marker Cones/ Tape

CLINICAL IMPLICATION-

LSVT BIG can be incorporated into standard physiotherapy regimens for diabetic neuropathy to improve balance and gait.

Improved postural control and gait may reduce the risk of falls in patients with diabetic neuropathy, especially in the elderly population.

The study provides clinicians with evidence to justify the use of LSVT BIG beyond its traditional Parkinson’s population.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Investigator 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

  • Diabetes diagnosed by physician • Both female and male • Age group- 40 to 70 years • Mentally stable • Walking independently without walking aids.

排除标准

  • Foot ulceration/infection/amputation Severe retinopathy/ Non operated Cataract Non-neuropathy related orthopedic, surgical or medical conditions Alcohol abuse Vestibular dysfunction.

结局指标

主要结局

• Berg Balance Scale (BBS)

时间窗: Baseline and 4 weeks

• 10-meter walk test (10mWT)

时间窗: Baseline and 4 weeks

次要结局

未报告次要终点

研究者

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

Dr Maansi Patel

B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde,

研究点 (1)

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