An International Classification of Functioning, Disability and Health (ICF)-Based Post-stroke Program for Meeting Activity and Participation Needs in Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Modified Barthel Index
研究概览
简要总结
Stroke is regarded as one of the leading causes of adult mortality and disability. Conventional rehabilitation programs for post-stroke patients focus on the augmentation of body functions. Their service delivery models are mostly operationalized according to the individual discipline's knowledge domain and practices. The International Classification of Functioning, Disability and Health (ICF) model provides a comprehensive framework which places focus on patients' activity and participation. It also emphasizes cross-disciplinary integration of service provision, patient-centred approach and personalization of treatment aims. This study is aimed to investigate how the ICF model can be integrated into the planning and implementation of personalized post-stroke programs, and evaluate the program's effectiveness in fulfilling the activity and participation needs of patients.
详细描述
Stroke is a neurological disease and is regarded as one of the leading causes of adult mortality and disability. Post-stroke rehabilitation to promote functional recovery is important to restitute the brain tissue to relearn and compensate for the lost functions. Early rehabilitation to enhance neuroplasticity within three to six months of post-stroke is recommended to reduce neurological deficits caused by stroke. Promising stroke rehabilitation interventions to tackle mobility and cognitive impairments include fitness training, upper and lower extremity interventions, and reminiscence therapy.
The ICF model is proposed by the World Health Organization to describe health and health-related domains. It was developed based on the biopsychosocial model. Within the model, disability and functioning are identified as difficulties in 1) body functions and structure; 2) activity; and 3) participation. They are affected by the interaction between health conditions and contextual factors. The former is different diseases, disorders and injuries, while the latter consists of environmental factors and personal factors. The ICF model has been widely applied in assessment, treatment and evaluation in various disciplines. On top of the ICF model, there is a related neurorehabilitation process framed by ICF which makes up four steps. The first step is the assessment to understand the diagnosis and consequences of the current health condition of an individual. Followed by the goal-setting part to formulate short-term or long-term rehabilitation plans for patients' perspective. These two steps will inform the therapists of an ICF rehabilitation plan with corresponding ICF codes to describe patients' health conditions. The third step is to launch appropriate interventions based on the ICF rehabilitation plan, and the final step is the outcome measurements to review the appropriateness of interventions. Yet, a similar process has seldom been applied in post-stroke rehabilitation to guide the treatment program.
This project aims to investigate how the ICF model can be integrated into planning and implementation of an ICF-based post-stroke rehabilitation program (ICF-PSRP), and evaluate the program's effectiveness on fulfilling the activity and participation needs of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had a diagnosis of stroke with an onset no more than 24 months,
- •were medically stable,
- •were able to transfer or walk with no more than one item of assistance, and
- •were able to tolerate at least 2 hours of active rehabilitation treatment.
- •Exclusion criteria:
- •Participants with neurological disabilities other than the stroke condition.
排除标准
- 未提供
结局指标
主要结局
Modified Barthel Index
时间窗: Up to 12 weeks
It measures the level of self-care management activities. Scores for the bladder, bowel, ambulation (indoor walking), stairs, dressing, feeding and on and off toilet items range from 0 to 10; transfer (bed mobility, sitting and floor), ambulation (outdoor walking), personal hygiene and bathing items range from 0 to 5. A higher score in each item indicates a better independence level, and vice versa for the dependence level on caregivers.
Elderly Mobility Scale
时间窗: Up to 12 weeks
It measures the mobility level. The lying to sitting and sitting to lying items range from 0 to 2. The functional reach item ranges from 0 to 4. Other items, including sit to stand, stand, gait and time walk, range from 0 to 3. A higher score in each item indicates a better independence level, and vice versa for the dependence level on caregivers.
Functional Test for the Hemiplegic Upper Extremity
时间窗: Up to 12 weeks
It measures the recovery of the hemiplegic upper extremity. The score ranges from level 1 to level 7 based on Brunnstrom's developmental stages of stroke recovery. A lower level reveals the severe impairment of the upper extremity to perform simple hand movements. A higher level indicates less or no impairments on the upper extremity to perform fine hand functional tasks.
Lawton Instrumental Activities of Daily Living Scale
时间窗: Up to 12 weeks
It measures the level of independent living. All items in the scale range from 0 to 3. A higher score in each item indicates a better independence level, and vice versa for the dependence level on caregivers.
Therapy Outcome Measure
时间窗: Up to 12 weeks
It assesses patients' abilities and difficulties in terms of their impairment, activity, participation, and well-being in expressive and receptive language abilities. All items range from 0 to 5. A lower score reflects severely impaired language abilities, while scores close to 5 indicate less impaired or no impairment in language abilities.
Manual Muscle Testing - Lower Extremity
时间窗: Up to 12 weeks
It measures lower extremity muscle strength impairments. The score ranges from 0 to 5. A lower score indicates a trend of weak or no movements detected on the lower extremity. A higher score indicates a trend of slight decline or no impairments in muscle contraction under full resistance.
Oxford Cognitive Screen
时间窗: Up to 12 weeks
It measures stroke-induced cognitive disabilities. Areas include attention (score ranges from 0 to 63), memory (score ranges from 0 to 12), language (score ranges from 0 to 22), praxis (score ranges from 0 to 12) and number (score ranges from 0 to 4). A higher score indicates fewer impairments in the specific area, and vice versa for a lower score in the specific area.
次要结局
- Goal Attainment Scale(Baseline)
- Stroke Specific Quality of Life Scale(Up to 12 weeks)