Impact of an Intensive Motor Rehabilitation Programme Integrating Technology for Adults With Central Neurological Disease: A Randomised Controlled Rehabilitation Study in the Chronic Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in Functional Independence Measure (FIM)
研究概览
简要总结
This project will consist of 1 large clinical trial with 3 core concepts: (1) Clinical benefits of an intensive rehabilitation programme using advanced technology, compared to the control group; (2) A full health economic evaluation combined with model-based estimation of costs and benefits; (3) process evaluation.
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
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
- •A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury:
- •Stroke: Participants must have received a diagnosis of stroke for the first time, have been diagnosed at least 3 months ago, and live at home.
- •SCI: Participants have a rating A, B, C or D on the American Spinal Injury Association (ASIA) measurement scale, which refers to patients with complete or incomplete impairment. All levels of SCI can be included, if there is a clear patient need linked to the upper and/or lower extremities.
- •At least 3 months post discharge from hospital/rehabilitation centre, living at home;
- •Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);
- •Had a normal functional state prior to the pathology: a pre-pathology Barthel Index > 85/100;
- •Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum score in all affected limbs = motricity index: score 5 on 3/3 segments)
- •Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist;
- •Age of > 18 years;
- •Sufficient cognitive ability to understand the games and give informed consent, assessed by a specialist;.
排除标准
- •Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist;
- •No ability to initiate movements against gravity in the upper and lower limbs;
- •Severe visual impairment, communication, cognitive and language formation problems that would prevent the intervention and measurement process, assessed by a specialist;
- •Any disorder, which in the investigator's opinion might the compromise participant's safety or compliance with the CIP;
- •Female who is pregnant, breast-feeding.
研究组 & 干预措施
Intensive rehabilitation program
3 weeks of intensive rehabilitation --> follow-up 9 months standard care
干预措施: Intensive rehabilitation programme (Other)
Standard care
Follow-up 9 months standard care --> 3 weeks of intensive rehabilitation
结局指标
主要结局
Change in Functional Independence Measure (FIM)
时间窗: Baseline - 3weeks - 9months
The Functional Independence Measure (FIM), which measures independence in daily functioning after stroke. The FIM consists of 18 items designed to assess to what extent a person needs assistance in performing activities of daily living safely and efficiently. The activities consist of a number of basic skills related to self-care, pelvic floor function, transfers, gait, communication and social abilities. The FIM has acceptable reliability and has been found valid in people with stroke. Min: 13; Max: 91; Higher = better
Change in Spinal Cord Independence Measure (SCIM)
时间窗: Baseline - 3weeks - 9months
Spinal Cord Independence Measure (SCIM), an assessment of achievements of daily function of patients with spinal cord lesions. The scale consists of 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. The SCIM is valid and reliable. Min: 0; Max: 100; Higher = better
次要结局
- Change in the 10 Meter Walk Test (10MWT)(Baseline - 3weeks - 9months (stroke only))
- Change in The Canadian Occupational Performance Measure (COPM)(Baseline - 3weeks - 9months)
- Change in EQ-5D-5L(Baseline - 3weeks - every month during follow-up - 9 months)
- Change in Goal Attainment Scaling (GAS)(Baseline - 3weeks - 9months)
- Change in The fatigue severity scale (FSS)(Baseline - 3weeks - 9months)
- Borg Rating of Perceived Exertion Scale(During intervention (up to 9 months))
- Change in the action research Arm Test (ARAT)(Baseline - 3weeks - 9months (stroke only))
- Change in the 6-minute Walk-Test (6MWT)(Baseline - 3weeks - 9months (stroke only))
- Change in rhe Fugl-Meyer Assessment (FMA)(Baseline - 3weeks - 9months (stroke only))
- Change in the functional Ambulation Classification (FAC)(Baseline - 3weeks - 9months (stroke only))
- Change in the Stroke Self-efficacy Questionnaire(Baseline - 3weeks - 9months (stroke only))