Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Gain in the prediction of manual dexterity recovery
研究概览
简要总结
In the proposed research, we will assess motor and sensory functions of the hand using clinical tests and a tool designed to measure manual dexterity combined with vibrotactile stimulation. We will also evaluate the integrity of brain structure and function using MRI.
详细描述
In this study, 90 post-stroke patients will be followed over three visits at 3 weeks, 3 months, and 6 months after stroke. Manual dexterity will be assessed using the Dextrain Manipulandum, both with and without the addition of finger vibrations. These vibrations will be delivered using vibratory rings, a tool that has been developed and is currently being validated in healthy participants and in patients with chronic post-stroke conditions. These measurements will allow us to quantify haptic facilitation, that is the impact of adding finger vibrations on hand motor function.
During each of the three visits, we will also administer validated sensory, motor, and cognitive clinical assessments, as well as anatomical, resting-state functional, and diffusion MRI sequences to investigate brain structure and function in relation to this haptic facilitation. These longitudinal measurements will enable the development of biomarkers of motor recovery of manual dexterity after stroke, with the primary objective of improving the prediction of dexterity recovery using a regression model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First symptomatic stroke, ischaemic or haemorrhagic in the early subacute phase (up to 3 weeks post-stroke)
- •Upper limb paresis (≤4/5 MRC Scale)
- •Ability to grasp, lift and put down 1 block (from the BBT test)
- •Be affiliated to a social security
排除标准
- •Presence of another neurological or musculoskeletal condition affecting upper limb movement
- •Severe cognitive impairment and/or aphasia with inability to understand and carry out instructions
- •Contraindications to MRI (claustrophobia, presence of cochlear implants and/or pacemakers)
- •Persons subject to legal protection measures
- •Persons subject to judicial protection measures
- •Pregnancy
- •Life-threatening conditions or conditions requiring follow-up at 6 months
- •Known hypersensitivity or allergy to silicone
研究组 & 干预措施
Stroke patients in the early subacute phase
Patients will be followed for 6 months over three visits. They will undergo validated sensory, motor, and cognitive clinical assessments, as well as MRI scans and manual dexterity tests performed with and without the addition of vibratory stimulation to the fingers, using a tool previously developed as part of this project.
干预措施: Haptic stimulation device (Device)
Stroke patients in the early subacute phase
Patients will be followed for 6 months over three visits. They will undergo validated sensory, motor, and cognitive clinical assessments, as well as MRI scans and manual dexterity tests performed with and without the addition of vibratory stimulation to the fingers, using a tool previously developed as part of this project.
干预措施: Brain MRI (Other)
Healthy controls matched in age, sex and laterality with stroke patients
Healthy control participants will be assessed during a single visit. They will undergo motor, sensory, and cognitive clinical assessments, as well as manual dexterity tasks performed with and without the addition of finger vibrations using a previously developed tool. They will also undergo anatomical, resting-state functional, and diffusion brain MRI sequences. Each healthy participant will be matched to a patient in terms of age, sex, and handedness of the affected limb. For example, if we include a 60-year-old male post-stroke patient who is right-handed and has a right upper-limb impairment, we will include a healthy male participant aged 60 ± 5 years who is also right-handed.
干预措施: Haptic stimulation device (Device)
Healthy controls matched in age, sex and laterality with stroke patients
Healthy control participants will be assessed during a single visit. They will undergo motor, sensory, and cognitive clinical assessments, as well as manual dexterity tasks performed with and without the addition of finger vibrations using a previously developed tool. They will also undergo anatomical, resting-state functional, and diffusion brain MRI sequences. Each healthy participant will be matched to a patient in terms of age, sex, and handedness of the affected limb. For example, if we include a 60-year-old male post-stroke patient who is right-handed and has a right upper-limb impairment, we will include a healthy male participant aged 60 ± 5 years who is also right-handed.
干预措施: Brain MRI (Other)
结局指标
主要结局
Gain in the prediction of manual dexterity recovery
时间窗: 3 months post enrollment
The primary outcome measure is a 10% improvement in the prediction of the Box and Block Test (BBT) score at 3 and 6 months post-stroke achieved by adding the haptic effect to a multivariate model.
次要结局
- Change in the prediction of the Box and Block Test (BBT) score when taking into account the haptic effect during an index finger force control task.(3 and 6 months post enrollment)
- Predicting recovery in various clinical tests of motor and sensory function and activity limitations at 3 months and 6 months post-stroke.(3 and 6 months post enrollment)
- Difference in functional and structural connectivity between subgroups with vs without haptic effect at 3 and 6 months(3 and 6 months post enrollement)
- Changes in the structural and functional connectivity of fronto-parietal networks between 3 weeks and 6 months post-stroke(3 and 6 months post stroke)
- Difference in brain connectivity between brain images of healthy subjects and patients 3 weeks post-stroke and healthy subjects and patients 6 months post-stroke.(6 months post enrollement)
- Correlation between the location of the lesion at 3 weeks and the haptic effect and the results of clinical tests(3 and 6 months post stroke)