Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Functional Ambulation Category (FAC) at 3 months
研究概览
简要总结
Robot-assisted gait training (RAGT) represents a modern concept of neurorehabilitation in stroke patients. This single-center randomized parallel-group neurorehabilitation trial with blinded primary outcome assessment is aimed at patients after the first-ever ischaemic stroke in the anterior or posterior cerebral circulation.
详细描述
The main aim is to determine, whether the RAGT by using the Lokomat exoskeleton device (Hoccoma, Switzerland) plus the protocol-defined conventional rehabilitation versus conventional rehabilitation improves the gait of post-stroke patients after 6 months. Both groups are treated with the protocol-defined rehabilitation (ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min). The Lokowalkers group undergoes the RAGT using the Lokomat Pro Freed device for 20-50 minutes 5 times a week for a total of 15 times for 3 weeks (a total of 1800 minutes). The primary endpoint is the Functional Ambulation Category (FAC) after 3 months. Secondary endpoints include FAC (after 15th therapy), 10-meter walk test (10MWT) (after 15th therapy, after 3 months), Timed Up and Go Test (TUG) (after 15th therapy and after 3 months, 3-months modified Rankin Scale (mRS), and Berg Balance Scale (BBS, after 15th therapy, after 3 months).
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
- None
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
- •signed informed consent by the participant or legal representative
- •interval between stroke and first rehabilitation session < 6 weeks (study target within 2 weeks)
- •age > 18 years
- •early modified Rankin scale (mRS) 2 to 4 (pre-stroke mRS 0 to 1)
- •early FAC of 0 to 3 (pre-stroke FAC of 5)
- •standing ability with support up to 3 minutes and vertical tolerance > 15 minutes
排除标准
- •inability or refusal to sign an informed consent
- •history of stroke or another brain disease (tumour, multiple sclerosis, brain or spinal cord injury)
- •severe internal, oncological, or surgical comorbidity preventing long-term re-habilitation or causing chronic or progressive gait disorder
- •limited collaboration of any reason, moderate or severe dementia assessed by using the Montreal Cognitive Assessment (MoCA) scale
- •impaired skin integrity in the lower torso and limbs preventing the use of Lokomat device
- •limitations given by the Lokomat exoskeleton device (weight > 135 kg, thigh-length 23-35 cm, shank length 35-47cm)
- •limitations given by the leg/lower body exerciser (weight > 180 kg, height < 120 cm or > 200 cm, (sub)acute lower limb fractures, deep vein thrombosis, skin disintegration)
- •any contraindication to perform brain MRI
结局指标
主要结局
Functional Ambulation Category (FAC) at 3 months
时间窗: 3 months
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.
次要结局
- Functional Ambulation Category (FAC) (after 3 weeks)(3 weeks)
- 10-meter walk test (10-MWT) (after 3 weeks and 3 months)(up to 3 months)
- Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)(up to 3 months)
- 3-months modified Rankin Scale (mRS)(up to 3 months)
- Adverse effects(up to 3 years)
- Early termination of the study(up to 3 years)
- Reason/s for the termination(up to 3 years)
- Berg Balance Scale (BBS, after 3 weeks, after 3 months)(up to 3 months)
- Study-related death or death unrelated to study(up to 3 years)