Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke (DESC-Glove)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 6
- 主要终点
- Device malfunctioning: number and types of device malfunctions
研究概览
简要总结
The goal of this clinical trial is to evaluate the DESC-Glove, an instrumented glove developed for sensorimotor rehabilitation in individuals recovering from a stroke, utilizing non-invasive vibrational feedback. The primary objective is to assess the technical functionality, safety, and reliability of the device during post-stroke rehabilitation, providing insights for future technical and functional improvements.
The secondary objectives are:
- To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals;
- To assess the short-term effects of the DESC-Glove on sensorimotor performance and manual dexterity in post-stroke individuals.
To meet the second objective, researchers will compare three groups:
an experimental treatment group (using the DESC-Glove during hand rehabilitation), a sham control group (using the DESC-Glove without vibration), and a conventional control group (receiving hand rehabilitation without the device).
详细描述
The study is divided into two phases:
Phase 1: Preliminary Investigation of Device Functionality. This phase involves testing the DESC-Glove on 5 patients to assess its initial functionality. Each patient will complete four treatment sessions using the device, focusing on both fine motor exercises for the hand and gross motor exercises for the upper limb. This phase will also help evaluate patient compliance with the rehabilitation treatment on a smaller scale, allowing for a better understanding of the recovery process's duration. During the treatment, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli synchronized with the exercises, following the device's operational guidelines.
Phase 2: Multicenter Randomized Controlled Trial (RCT).
In this phase, 42 participants will be recruited and randomly assigned to one of three parallel groups (1:1:1):
The experimental treatment group (using the DESC-Glove), The sham control group (using the DESC-Glove without vibration), and The conventional control group (not using the DESC-Glove). The sample size of 42 (14 participants per group) was chosen following Julious et al. [doi: 10.1002/pst.185], which recommends a minimum of 12 subjects per group for pilot studies. This number was increased to 42 to account for potential dropouts, ensuring robust data collection and analysis.
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
- Single (Outcomes Assessor)
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
- •Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI);
- •Time from the acute event between 1 and 6 months;
- •Mild to moderate impairment of the upper limb, assessed using the Motricity Index (item score for "pinch grip" ≥ 19 and scores for "elbow flexion" and "shoulder abduction" ≥ 14).
排除标准
- •Severe behavioral and cognitive disorders (Montreal Cognitive Assessment (MoCA) ≤ 15 ) and/or decreased compliance;
- •Spasticity or hypertonia (Modified Ashworth Scale (MAS) > 3) in the affected limb;
- •Concurrent participation in a rehabilitation trial that includes treatment training for the upper limb following a stroke;
- •Refusal to sign informed consent.
结局指标
主要结局
Device malfunctioning: number and types of device malfunctions
时间窗: For both the first and second phase of the study: within one day after each rehabilitation session.
This outcome measure is designed to systematically document and analyze any malfunctions of the DESC-Glove device throughout the study. All malfunctions will be recorded in detail, including the frequency and type of malfunction. Each issue will be categorized based on the nature of the malfunction, such as hardware failures (e.g., sensor or vibration issues), software, or connectivity problems. This data will be used to assess the overall reliability and functionality of the device, guiding future improvements and treatment efficacy.
Device malfunctioning: number of dropouts device-related
时间窗: For both the first and second phase of the study: within one day after each rehabilitation session.
This outcome measure aims to document the number of participants who withdraw from the study specifically due to issues related to the device.
次要结局
- Clinical outcome: Box and Blocks test(For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).)
- Clinical outcome: Frenchay Arm Test(For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).)
- Clinical outcome: Thumb Localizing Test(For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).)
- Clinical outcome: 5-level EQ-5D(For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).)
- Instrumental Outcome: Pick and Lift test(For both the first and second phase of the study: Baseline (within 3 days before the first rehabilitation session); Weekly assessment (within 3 days after the last rehab session of each week).)
- Instrumental Outcome: Pick and Place test(For both the first and second phase of the study: baseline assessment (within 3 days before the first rehabilitation session) and final assessment (within 3 days after the last rehabilitation session).)
- Questionnaire: System Usability Scale(For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).)
- Questionnaire: Gradibility of the Device(For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).)
- Questionnaire: Technology Acceptance Model(For both the first and second phase of the study: final assessment (within 3 days after the last rehabilitation session).)
研究者
Christian Cipriani
Scientific Director
Scuola Superiore Sant'Anna di Pisa