Use of Robotics to Improve Cognitive Functions in Subject With Subacute Stroke: a Bicentric Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Symbol Digit Modalities Test (SDMT)
研究概览
简要总结
A recent multicenter study of the Fondazione Don Gnocchi (FDG) Robotic Rehabilitation Group (NCT02879279) showed the efficacy of robotic rehabilitation in upper limb motor recovery after stroke using a set of robots and sensor-based devices. In clinical practice, beside sensory-motor deficits, stroke patients often present concomitant cognitive impairments (as attention and memory disorders). The robotic and technological systems used in the above-mentioned study allow training on some cognitive functions such as visual memory, visual-spatial functions and working memory, as well as motor training of the upper limb. The aim of the study is to assess whether cognitive functions, such as visual memory, visual-spatial skills and working memory (evaluated with specific tests) improve after robotic therapy of the upper limb in subacute stroke patients.
详细描述
It is estimated that up to three quarters of acute and subacute stroke survivors exhibit cognitive impairment. Cognitive impairment can significantly compromise functional recovery, quality of life, and social engagement after stroke. Indeed, some authors showed that the impairment of cognitive functions can negatively influence rehabilitation strategies. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and intensity of the therapy, and to standardize the treatment, adding a complex but controlled multisensory stimulation to the patient. In fact, owing to the complex training environments, robotic and technological devices may promote the re-learning capacity, inducing functional or structural plasticity in brain networks that control both motor and cognitive functions. Our hypothesis is that the cognitive engagement of patients during upper limb robotic therapy can impact on some cognitive functions that are compromised after the stroke.
The current pilot study aims to evaluate the effects of an upper limb robotic rehabilitation treatment on cognitive functions in patients with subacute stroke.
Fifty consecutive patients with sub-acute stroke (within 6 months of the event) will be enrolled in two rehabilitation centers.
All patients will perform a robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of robotic devices. The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive functions, and speed of processing. Furthermore, patients will undergo a comprehensive rehabilitation program including individual conventional physiotherapy (6 times/week), lasting 45 minutes focused on lower limb, sitting and standing training, balance and walking.
Subjects will be evaluated at baseline (T0) and after treatment (T1). To be included in the analysis, patients will have to undergo at least 25 rehabilitation sessions, without interrupting the treatment (due to clinical complications) for more than six consecutive sessions; otherwise, they will be considered as dropouts.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first ischemic or hemorrhagic stroke (verified by MRI or CT);
- •time latency within 6 months from stroke (subacute patients);
- •age between 35-85 years;
- •cognitive abilities adequate to understand the experiments and the follow instructions Token test ≥26.5 (correction as for age and school level);
- •upper limb impairment (FMA score ≤58);
- •ability to give written consent;
- •compliance with the study procedures.
排除标准
- •history of recurrent stroke;
- •inability to understand the instructions required for the study;
- •fixed contraction in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
- •severe deficits in visual acuity.
研究组 & 干预措施
Robotic assisted intervention
Upper limb robotic therapy using a set of robotic and sensor based devices and exercises specifically selected to train cognitive functions.
干预措施: Robotic assisted intervention (Device)
结局指标
主要结局
Change in Symbol Digit Modalities Test (SDMT)
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
SDMT evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used. For each correct answer, a point is assigned.
次要结局
- Tower of London (TOL)(Baseline (T0), Treatment (6 weeks) (T1))
- Change in Digit Span (DS)(Baseline (T0), Treatment (6 weeks) (T1))
- Change in Rey-Osterrieth Complex Figure Test (ROCF).(Baseline (T0), Treatment (6 weeks) (T1))
- Change in Stroop and Color Word test (SCWT)(Baseline (T0), Treatment (6 weeks) (T1))
研究者
Irene Giovanna Aprile
M.D., Ph,D, Principal Investigator, Head of Rehabilitation Unit
Fondazione Don Carlo Gnocchi Onlus