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临床试验/CTRI/2024/06/068657
CTRI/2024/06/068657招募中2/3 期

Effect of Upper limb Peripheral Nerve Mobilization on Motor Abilities, Nerve conduction, and Cortical activity in subjects with middle cerebral artery (MCA) Stroke

Surya Vishnuram1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
Functional Magnetic Resonance Imaging (FMRI)

研究概览

简要总结

**Introduction: -**Stroke is a debilitating neurological condition that occurs when the blood supply to the brain is disrupted, leading to a sudden loss of brain function. Stroke can give rise to various complications that further impact the individual’s functional abilities and overall well-being. These complications include muscle contractures, spasticity, joint stiffness, pain, reduced mobility, and a heightened risk of falls and injuries. These factors contribute to long-term disability and reduced quality of life for stroke survivors. Current interventions for stroke rehabilitation typically focus on motor impairments and functional recovery through various rehabilitation approaches. These interventions aim to improve muscle strength, coordination, and relearn functional tasks. While these conventional approaches have shown efficacy, there is a growing recognition that neural factors may play a crucial role in functional recovery after stroke. Peripheral nerve mobilization (PNM) techniques aim to reduce neural tension, enhance nerve gliding, and promote neural tissue mobility. These techniques have been used in various musculoskeletal and neurological conditions, demonstrating promising effects on nerve conduction, functional improvement, and cortical activity.

 **Need of the study: -**This study will contribute to the understanding of the potential benefits of peripheral nerve mobilization as a key rehabilitation approach in stroke care, addressing the neural aspects of recovery that may have been overlooked by conventional therapies. The findings will provide valuable insights for the development of more comprehensive and tailored rehabilitation strategies for stroke survivors, ultimately improving their overall functional outcomes and quality of life.

 Objectives: -

a) To assess the effect of upper limb peripheral nerve mobilization on motor abilities in middle cerebral artery stroke subjects.

b) To examine the effect of upper limb peripheral nerve mobilization on cortical activity in middle cerebral artery stroke subjects.

C) To assess the effect of upper limb peripheral nerve mobilization on median, radial, and ulnar nerve conduction in middle cerebral artery stroke subjects.

    Methodology: - 66 participants will be recruited with middle cerebral artery (MCA) Stroke based on selection criteria. Informed consent and information sheet will be explained and obtained from all participants with their voluntary consent. Included participants will be undergoing pretest such as Fugl Meyer Assessment – upper limb (FMA- UL) for functional performance, Functional Magnetic resonance Imaging (FMRI) for Cortical Activity, and Nerve conduction study for Radial, Median, and Ulnar nerve conduction velocity.

After completion of the pre-test, Participants will be allocated in to two groups by concealed envelope method as Experimental group (n=33) and Control group (n=33). Experimental group will be receiving Peripheral Neural Mobilization (PNM) techniques along with conventional exercises and control group will be receiving conventional exercises alone. Both the groups will be treated for 1 hour session per day, 4 days a week for a period of 8 weeks.

 **Statistical analysis:-**Sample size (66) is estimated assuming 4% population proportion with 5% significance level and 95% confidence interval with 10% drop-out rate. For both experimental and control group samples will be allocated through concealed envelope as 33 in each group. Statistical analysis will be performed using Mann-Whitney U tests for between-group comparisons and Wilcoxon test for within-group comparisons.

Expected outcomes: -

The primary expected outcomes of the study include significant improvements in cortical activity and connectivity patterns of Functional MRI indicating the effectiveness of upper limb peripheral nerve mobilization (PNM). Additionally, enhanced nerve conduction in the Radial, Median, and Ulnar nerves post-intervention is anticipated, reflecting improved nerve functionality. Also improved motor abilities, measured through the wolf motor function test (WMFT) is expected.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Middle cerebral artery (MCA) Stroke subjects aged 40-75 years, 2) Less than 6 months of stroke onset (acute and sub-acute), 3) Subjects with mild to moderate functional impairments assessed using national institute of health stroke scale (NIHSS) scale, 4) Voluntary motor control (VMC) grading more than 3, 5) Modified Ashworth Scale (MAS) less than 1+, 6) Both male and female will be included.

排除标准

  • Severe muscle stiffness with Voluntary motor control (VMC) less than 3
  • Stroke subjects with other artery involvement (Anterior Cerebral Artery, Posterior Cerebral Artery or other)
  • Participants with recurrent stroke and other neurological disorders.
  • Participants with other musculoskeletal disorders.
  • Participants with radiculopathy.
  • Red flag signs as tumour, cancer, severe osteoporosis.
  • Participation in other trials.

结局指标

主要结局

Functional Magnetic Resonance Imaging (FMRI)

时间窗: 8 weeks

次要结局

  • , Nerve Conduction study, Wolf Motor Function Test(8 weeks)

研究者

发起方
Surya Vishnuram
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Surya Vishnuram

Saveetha College of Physiotherapy

研究点 (1)

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