The Effectiveness of Anti-spastic Splint With Added Focal Muscle Vibration (FMV) in Decreasing Hand Spasticity and Improving Hand Functionality Among Individuals With Chronic Stroke: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale (MAS)
研究概览
简要总结
Title: The Effect of Vibrating Splint on Hand Function After Stroke
Summary:
This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.
Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.
The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.
The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.
The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.
This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements.
详细描述
This pilot randomized controlled trial (RCT) aims to assess the clinical effectiveness and efficacy of adding focal muscle vibration (FMV) to anti-spastic splint therapy for individuals with spasticity following a stroke. The study involves multiple centers in the Jenin area of Palestine, utilizing outpatient rehabilitation centers to recruit participants who have chronic spasticity post-stroke.
Study Objectives and Questions:
Determine whether adding FMV to anti-spastic splint therapy provides additional benefit for individuals with spasticity after a stroke.
Compare the outcomes of anti-spastic splint therapy, FMV therapy, and a combination of both interventions in individuals with post-stroke spasticity.
Explore participant perceptions regarding the effectiveness, acceptability, and adherence to the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
In this clinical trial, due to the nature of the interventions, it may not be possible to mask or blind the participants or therapists to the treatment received. However, efforts will be made to blind the outcome assessors who will be responsible for evaluating the participants' hand function, spasticity, and other outcome measures. Blinding the outcome assessors helps minimize potential bias and ensures the objective assessment of the intervention's effectiveness. By keeping the assessors unaware of the participants' group allocations, the integrity and reliability of the study findings can be enhanced.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals affected by chronic (more than one year) spastic ischemic or hemorrhagic stroke
- •Aged above 18 years old
- •Medically stable (has no cardiovascular event in the last 12 months)
- •A score of 1-4 on modified Ashworth scale.
排除标准
- •Cardiovascular event in the past 12 months
- •Received anti-spastic injections drugs into the affected hand in the last 6 months
- •A score of less than 21 on Rowland Universal Dementia Assessment Scale (RUDAS)
- •Upper limb and trunk musculoskeletal injuries
- •A score of 0 on modified Ashworth scale.
结局指标
主要结局
Modified Ashworth Scale (MAS)
时间窗: At day one, and the end of the intervention (after 4 weeks).
Spasticity level will be evaluated using the MAS scale. The MAS measures muscle resistance during passive stretching. The test will be applied for spastic joints of affected upper extremities. The score will be recorded as (0, 1, +1, 2, 3, 4), (0= normal tone, 4 = affected part rigid in flexion or extension). The reliability of the modified Ashworth scale is very good (kappa = .84 for interrater and .83 for intra-rater comparisons). Measurement repetition will be performed by the same assessor to avoid affecting reliability. The test will be conducted in the assessment quiet room, with no distractions. The participants will be supine in a treatment bed, and therapist will assess the affected upper limb spasticity once and record the result in the assessment form. The assessor will be a qualified trained occupational therapist who has worked in a clinical role treating stroke patients with hand spasticity and familiar with MAS.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
时间窗: At day one, and the end of the intervention (after 4 weeks).
The FMA-UE looks at reflex activity, volitional movement within synergies, volitional movement mixing synergies, and volitional movement with little or no synergy. The outcome scale's 33 items are divided into four subscales: shoulder and elbow, wrist, hand, and coordination. On a three-point ordinal scale, each of these items is assessed. 2 points are granted if a movement is completely completed, 1 point is awarded if the movement is half completed, and 0 points are awarded if the movement cannot be completed.
Range of Motion Assessment
时间窗: At day one, and the end of the intervention (after 4 weeks).
The assessment of Range of Motion (ROM) for the affected upper limb in stroke patients will employ the use of a goniometer to precisely measure joint mobility across multiple planes of movement. This comprehensive evaluation entails examining the patient's ability to actively or passively articulate their affected elbow, wrist, and hand joints. The measurement of each movement will be made through the goniometer-based approach.
Numeric pain rating scale (NRS)
时间窗: At day one, and the end of the intervention (after 4 weeks).
Numeric pain scale (NRS) is an essential tool for the assessment of pain intensity. It is widely used by healthcare providers. It consists of a horizontal line where the left end is labeled "no pain" or "0," indicating the absence of pain, while the right end is labeled as "worst pain imaginable" or "10". The participants are required to mark on the line the point that shows the pain level they are experiencing. The distance from the origin of the line, which is the left end, to the participant's symbol mark is the one that is used to present a numerical value. a representation which shows pain intensity, where the higher the value the more pain there is. The NRS is taken into account as a valid and reliable scale and is usually employed in to analyze pain intensity in clinical practice and to conduct research.
次要结局
未报告次要终点
研究者
Amer Jaroshy
Principal Investigator
Arab American University (Palestine)