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临床试验/CTRI/2025/02/079927
CTRI/2025/02/079927招募中不适用

Predicting upper limb sensorimotor recovery using data driven models in patients with stroke

Siddharth Savadia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
1. National Institutes of Health Stroke Scale

研究概览

简要总结

The sensorimotor recovery of the upper extremity is an underexplored field, making it complex to develop effective rehabilitation goals and personalized therapy. Predictive models can be crucial in planning rehabilitation strategies, enabling the rehabilitation team to create suitable treatment plans based on these predictions. This prospective cohort study aims to develop and validate data-driven models for predicting upper limb sensorimotor recovery using conventional statistical and machine learning techniques. A physiotherapist will measure the outcome at four different time points, with these outcomes being divided into independent and dependent variables. Newly diagnosed stroke patients admitted to the hospital will be screened for selection criteria, and potential participants will be invited to take part in the study. Those who agree to participate will be informed and asked to provide written consent. Baseline demographic characteristics such as age, gender, dominance, ethnicity, level of education, premorbid status, comorbidities, site and subtype of stroke, CT and MRI findings will be recorded. Assessments, including NIHSS, motricity index, grip, and pinch strength, will be conducted within 7 days of the stroke, along with kinematic analysis of the upper limb functional task. Follow-up sessions will assess dependent variables including motor functions, sensory perception, and quality of life. After data collection, significant factors contributing to predicting sensorimotor recovery will be identified, and a prediction model will be developed and validated.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician.

排除标准

  • Individual admitted in hospital after seven days of stroke
  • Individuals who are unable to follow three-step commands and cannot comprehend
  • Individuals who have undergone surgical procedures related to brain
  • Individual with any pre-existing impairment affecting the upper extremity
  • Any other musculoskeletal conditions or significant medical problems or co-morbidities 6 Participants not willing to give consent or Uncooperative
  • Individual with bilateral stroke
  • Individuals with conditions that are restricting the kinematic analysis.

结局指标

主要结局

1. National Institutes of Health Stroke Scale

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

2. Motricity index

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

3. Grip strength

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

4. Pinch strength

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

5. Shoulder abduction and finger extension score

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

6. 3D kinematic analysis of upper limb movement

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

7. 2D kinematic analysis of upper limb movement

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

8. Erasmus MC modification of Nottingham Sensory Assessment

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

9. Hospital Anxiety and Depression Scale (HADS)

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

10. Montreal Cognitive Assessment (MoCA)

时间窗: Within 7 days post stroke, up to 5 weeks post stroke

次要结局

  • 1. Fugl-Meyer Assessment for upper extremity (FMA-UE)(2. Erasmus MC modification of Nottingham Sensory Assessment)

研究者

发起方
Siddharth Savadia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Siddharth Savadia

Manipal College of Health Professions

研究点 (1)

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