Exploring Cognitive Recovery: the Impact of Sensor-based Robotic Rehabilitation in Neurological and Neurodegenerative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease)
研究概览
简要总结
The goal of this clinical trial is to learn if sensor-based robotic upper limb rehabilitation can improve cognitive and motor functions in adults with neurological and neurodegenerative disorders, including Parkinson's disease, multiple sclerosis, and stroke. The main questions it aims to answer are:
Does sensor-based robotic rehabilitation improve cognitive functions such as attention, memory, and executive functions? Does this rehabilitation lead to better motor recovery and daily functioning compared to conventional therapy? Researchers will compare the experimental group receiving robotic rehabilitation with cognitive tasks to the control group receiving conventional therapy to see if the robotic approach leads to greater improvements in both cognitive and motor outcomes.
Participants will:
Receive upper limb rehabilitation using robotic devices and virtual reality-based exercises or conventional therapy Complete a series of neuropsychological assessments before and after the intervention to measure cognitive changes Complete motor function tests before and after the intervention to evaluate physical improvements Participate in 25 training sessions, 2-3 times per week, each lasting 60 minutes
详细描述
The CROSS-ND study is a randomized controlled trial designed to evaluate the effectiveness of sensor-based robotic upper limb rehabilitation combined with cognitive exercises in adults with neurological and neurodegenerative disorders, including Parkinson's disease, multiple sclerosis, and stroke. Traditional rehabilitation often focuses primarily on motor recovery, but cognitive impairments frequently co-occur and can limit functional gains. This study integrates cognitive tasks within robotic rehabilitation to target both motor and cognitive deficits simultaneously, promoting neuroplasticity and functional independence.
Participants will be randomly assigned to either the experimental group, receiving robotic and virtual reality-based upper limb training with embedded cognitive exercises, or the control group, receiving conventional therapy. Each participant will complete 25 sessions over 2-3 months, with training intensity and difficulty adapted to individual performance.
Assessments will include neuropsychological tests tailored to the patient's condition (ACE-R for Parkinson's, BRB-N for multiple sclerosis, RBANS for stroke) and motor evaluations using standardized tools such as Fugl-Meyer Assessment, Nine Hole Peg Test, and robotic device metrics. Cognitive and motor outcomes will be measured at baseline (T0) and immediately post-intervention (T1).
This study aims to demonstrate that a personalized, integrated rehabilitation approach can improve cognitive functions (attention, memory, executive functions, visuospatial skills) while enhancing motor recovery and daily living activities. Secondary objectives include analyzing correlations between cognitive and motor improvements, evaluating psychological well-being, and exploring the influence of patient characteristics (age, severity, disease stage) on rehabilitation outcomes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years;
- •FMA-UL 0-31: eligible for exoskeletons and robotic devices with high support. (Armeo Power, Amadeo, Motore)
- •FMA-UL 32-47: eligible for end-effectors with medium support. (Armeo Spring, Hand Tutor, Diego)
- •FMA-UL 48-52: eligible for sensor-based with low support. (Pablo, Diego, Armeo Senso)
- •MoCA: ≤ 20
排除标准
- •Severe cognitive disorders
- •Behavioral disorders
- •Sensory disorders
研究组 & 干预措施
Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)
Participants receive upper limb rehabilitation using sensor-based robotic devices and virtual reality exercises, with integrated cognitive tasks to simultaneously improve motor function and cognitive abilities.
干预措施: Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR) (Device)
Standard Conventional Therapy (SCT)
Participants receive conventional upper limb rehabilitation, including standard physiotherapy exercises, without robotic assistance or integrated cognitive tasks.
干预措施: Standard Conventional Therapy (Device)
结局指标
主要结局
Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease)
时间窗: From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
Addenbrooke's Cognitive Examination-Revised (ACE-R) total score ranges from 0 to 100, with higher scores indicating better cognitive performance. ACE-R will be administered at baseline (T0) and at end of intervention (T1). The primary metric will be change from baseline (T1 - T0) in ACE-R total score. Results will be summarized as mean (SD) change (or median \[IQR\] if non-normal) and compared between robotic rehabilitation and conventional therapy groups.
Between-group difference in change from baseline in Brief Repeatable Neuropsychological Test (BRNT) composite score (Multiple Sclerosis)
时间窗: From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
The BRB-N is a neuropsychological battery (multiple subtests). Subtest scores will be standardized into z-scores and aggregated into a composite (e.g., mean z-score across predefined subtests). Z-scores have no fixed minimum or maximum; higher values indicate better cognitive performance.The BRNT will be administered at T0 and T1. The primary metric will be change from baseline (T1 - T0) in a composite score derived from BRNT components (standardized z-scores aggregated into a single composite). Results will be summarized as mean (SD) change and compared between groups.
Between-group difference in change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index score (Stroke)
时间窗: From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
RBANS Total Scale Index score ranges from 40 to 160, with higher scores indicating better cognitive performance. RBANS will be administered at T0 and T1. The primary metric will be change from baseline (T1 - T0) in RBANS Total Scale Index score. Results will be summarized as mean (SD) change (or median \[IQR\]) and compared between robotic rehabilitation and conventional therapy groups.
次要结局
- Between-group difference in change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE/FMA-UL) score(From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).)
- System Usability Scale (SUS) score for robotic device usability at end of treatment(From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).)
- Goal Attainment Scaling (GAS) T-score at end of treatment(From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).)
研究者
Desiree La Tella
Principal Investigator
IRCCS Centro Neurolesi Bonino Pulejo