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临床试验/NCT07340034
NCT07340034已完成不适用

Effects of Focal Muscle Vibration Versus Whole Upper Limb Vibration on Spasticity and Upper Motor Control Functions in Post-Stroke Patients

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年4月21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
54
试验地点
1
主要终点
Fugl-Meyer assessment of upper limb (FMA-UE)

研究概览

简要总结

This study contributes to the growing body of knowledge on rehabilitation strategies for post-stroke patients, specifically focusing on the efficacy of vibration therapy modalities. By comparing focal muscle vibration therapy and whole upper limb vibration therapy, the research aims to provide empirical evidence that can inform clinical practices and enhance rehabilitation outcomes. The findings are expected to clarify which modality is more effective in reducing spasticity and improving motor control, thereby guiding clinicians in selecting appropriate interventions tailored to individual patient needs, increasing chances of benefits, time management and useful for academic purpose. Furthermore, the study addresses a critical gap in the literature, facilitating further research and discussion on the mechanisms underlying vibration therapy's effects.

Ultimately, this research aims to reduce spasticity and improve community outcomes by enhancing the quality of life for stroke survivors, enabling them to regain independence and participate more fully in daily activities by regaining the motor control functions. By contributing to both theoretical and practical frameworks, the study seeks to advance the field of neurorehabilitation and support informed decision-making among healthcare professionals.

详细描述

Motor impairment post-stroke, which usually affects the movement of the face, arm, and leg on one side of the body, impacts approximately 80% of individuals who have experienced a stroke. Upper limb motor impairments (involving the arm, hand, and/or fingers) are often long-lasting and debilitating; only about half of stroke survivors with an initially paralyzed upper limb recover some useful function within six months.

Recently, mechanical vibrations have been utilized as a form of somatosensory stimulation to enhance motor function and to address muscle spasticity in the upper limbs following a stroke. When applying vibration stimuli during exercise or physical rehabilitation, these can be broadly classified into two categories: (a) vibrations that are directly applied to a specific muscle or tendon, and (b) indirect vibrations that are not limited to a specific muscle, delivered either through the feet while standing on a platform or through the hands using a handheld device. The direct application of vibrations to a muscle or tendon is often referred to as focal muscle vibration (FMV) or segmental vibration (SV), and it may also be called repetitive muscle vibration (rMV). In contrast, indirect vibrations delivered through the hands are typically known as upper limb vibration (ULV), while those aimed at the lower limbs are referred to as whole-body vibration (WBV).

Vibration therapy (VT) is a form of physical therapy that employs mechanical vibration waves to stimulate the human neuromuscular system for therapeutic benefits. It demonstrates promising potential for use in the rehabilitation of dysfunctions part of bosy resulting from a stroke.

Focal muscle vibration (FMV) OR segmental muscle vibration is a relatively new approach used to enhance motor function and reduce spasticity in the hemiplegic upper limb of stroke patients. In FMV, a vibratory stimulus is delivered to a specific muscle tendon via a mechanical device, which activates the muscle spindle primary endings and generates Ia inputs. Vibration applied to a muscle can elevate the motor-evoked potential recorded from that muscle at rest, indicating an increase in corticospinal excitability during the vibration. Additionally, studies have shown that the duration of the cortical silent period in a forearm flexor muscle can increase when the antagonist forearm extensors are vibrated, providing strong evidence that pure sensory stimulation can influence motor cortical excitability.

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, Outcomes Assessor)

盲法说明

outcome assessor will be blind about participants allocation; this will ensure that their evaluations are objective and not influenced by knowledge of which treatment group participants belong to. Participants in both groups will be masked to the treatment of the other group by scheduling their sessions at different times

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of first-ever ischemic stroke
  • Age from 45 to 60 years
  • Both male and female participants
  • Onset of stroke 3 month to 6 months previously
  • Modified Ashworth Scale (MAS) score for the upper limb muscles on the hemiparetic side between 1+ and 3
  • Able to follow verbal commands and sign informed consent forms

排除标准

  • Cardiovascular disease or uncontrolled diabetes
  • Upper limb muscle contracture on the affected side
  • Peripheral neuropathy
  • Uncontrolled hypertension
  • Malignant tumors
  • Uncontrolled seizures

研究组 & 干预措施

Focal muscle vibration through focal muscle vibrator along with conventional neurorehabilitation

Experimental

Group A will receive the Focal muscle vibration in the major group of muscle such as Elbow flexors and wrist flexors along with the conventional neurorehabilitation.

干预措施: Focal muscle vibration through focal muscle vibrator along with conventional neurorehabilitation (Other)

Upper limb vibration through whole body vibrator along with conventional neurorehabilitation

Active Comparator

Group B will receive the upper limb vibration which will include all muscles of effected limb along with the conventional neurorehabilitation.

干预措施: Upper limb vibration through whole body vibrator along with conventional neurorehabilitation (Other)

结局指标

主要结局

Fugl-Meyer assessment of upper limb (FMA-UE)

时间窗: baseline, after 2 weeks and 4 weeks

The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a commonly utilized tool for measuring motor impairment in stroke rehabilitation. The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity in acute and subacute populations have been widely reported. The UE section of the FMA consists of 33 items and is scored on a 3-point ordinal scale with 0 meaning cannot perform, 1 meaning can partially perform, and 2 meaning can perform fully. Scores are summed with a maximum potential score of 66 points.

Modified Ashworth scale (MAS)

时间窗: baseline, after 4 weeks and 8 weeks

The Modified Ashworth Scale (MAS) is the most widely used clinical tool for measuring increased muscle tone or spasticity The MAS has demonstrated excellent test-retest and inter- and intra-rater reliability, The inter-rater reliability of the scale has been reported to vary significantly depending on the muscle group being assessed, the examiner's experience, and methodological inconsistencies in applying the scale. The scale is as follows: 0: No increase in muscle tone 1. Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion 2. A marked increase in muscle tone throughout most of the range of motion 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

次要结局

未报告次要终点

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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