Changes in Biosocial and Cognitive Functions and Quality of Life When Applying Different Smart Technologies in Stroke Patients During Early Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in biosocial functions
研究概览
简要总结
The goal of this interventional study is to evaluate the impact of applying different smart technologies during early rehabilitation after stroke. The primary hypothesis is that the use of smart technologies in the early stage of rehabilitation will significantly improve biosocial and cognitive functions, quality of life, and participation in activities. Furthermore, the extent of these improvements may differ depending on the type of technology used and individual patient characteristics.
The specific aims of the study are:
- To evaluate changes in biosocial and cognitive functions in stroke patients using different smart technologies during early rehabilitation.
- To assess changes in quality of life and participation in daily activities.
- To compare the effectiveness of different smart technologies on recovery outcomes.
- To identify patient-specific factors influencing rehabilitation results. A total of four groups will be studied. Three experimental groups will receive interventions with different interactive rehabilitation technologies (RecoveriX, Gloreha Aria, E-Link). The control group will undergo standard occupational therapy. All groups will receive the same level of conventional rehabilitation and medical care.
Assessments will be conducted at the beginning and end of the 6-7 week rehabilitation program, covering motor, cognitive, and biosocial functioning, as well as quality of life.
The results are expected to provide new knowledge on the effectiveness of smart technologies in stroke rehabilitation, to guide the development of personalized rehabilitation programs, and to support evidence-based decisions for occupational therapy and health care practice.
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)
盲法说明
Outcome assessors will be blinded to group assignment; participants and care providers will be aware of the intervention.
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
- 否
入选标准
- •Signed informed consent.
- •Ischemic stroke confirmed by imaging (CT or MRI).
- •Hemiplegia/hemiparesis with arm motor deficit (muscle strength ≤ 4 points on Lovett scale).
- •Time since stroke ≤ 1 month.
- •No severe cognitive impairment (MMSE ≥ 18).
- •Native Lithuanian speaker.
排除标准
- •Declines participation.
- •Contraindications for RecoveriX (metallic implants in the head, cochlear implants, cardiac pacemaker).
- •Previous craniotomy or severe head trauma with loss of consciousness.
- •Epilepsy or history of seizures.
- •Severe aphasia or severe comprehension impairment (MMSE < 18).
- •Severe comorbidities affecting biosocial functions.
- •Previous significant arm function deficits unrelated to stroke.
- •Severe visual or hearing impairments interfering with participation.
- •Unilateral neglect syndrome (Hemispatial neglect).
结局指标
主要结局
Change in biosocial functions
时间窗: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Functional Independence Measure (FIM), a standardized tool assessing functional independence in activities of daily living. Scores range from 18 to 126, with higher scores indicating greater functional independence.
Change in cognitive functions
时间窗: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Montreal Cognitive Assessment (MoCA), a screening tool for cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Change in biosocial functions
时间窗: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Functional Independence Measure (FIM), a standardized tool assessing functional independence in activities of daily living. Scores range from 18 to 126, with higher scores indicating greater functional independence.
Change in cognitive functions
时间窗: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Montreal Cognitive Assessment (MoCA), a screening tool for cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Change in quality of life
时间窗: Baseline (Day 1) and after 6 weeks of rehabilitation.
Measured using the Short Form-36 (SF-36) questionnaire. Scores range from 0 to 100 for each domain, with higher scores indicating better quality of life.
次要结局
- Grip strength(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Gross manual dexterity(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Fine motor dexterity(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Change in pain and fatigue levels(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Change in motivation and willpower(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Participation in daily activities(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Upper extremity motor function(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Change in pain and fatigue levels(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Change in motivation and willpower(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Participation in daily activities(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Upper extremity motor function(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Gross manual dexterity(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Fine motor dexterity(Baseline (Day 1) and after 6 weeks of rehabilitation.)
- Grip strength(Baseline (Day 1) and after 6 weeks of rehabilitation.)
研究者
Erika Endzelyte
Researcher
Lithuanian University of Health Sciences