Effects of Robot-assistED Rehabilitation Versus OccupatIonal Therapy on the Functional Recovery of the Upper Limb in PatiEnts with Chronic STroke: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Manual dexterity
研究概览
简要总结
The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. The project aims to assess the effects on the functional recovery, with manual dexterity as the primary outcome, of a treatment protocol using an innovative tool (Gloreha Sinfonia) that enables assisted execution of three-dimensional tasks combined with Serious Games for cognitive stimulation, targeting the functional recovery of the upper limb in patients with stroke outcomes at least 6 months after the acute event (chronic phase). Patients with residual dysfunction of the upper limb, at least 6 months after the stroke, will be randomly assigned to the Robotic Rehabilitation group (ROBOT), the Occupational Therapy group (OT), focused on the use of the upper limb in functional tasks (task-oriented training), or the control group (CT - prescription of a home exercise program). Patients in the ROBOT and OT groups will undergo a total treatment period of 5 weeks, with 3 sessions per week lasting 1 hour, for a total of 15 sessions/hours of treatment. Patients assigned to the CT group will undergo an initial functional assessment required for defining the exercise program. All patients will be evaluated at baseline (T0), at a 5-week interval (T1), and 6 months after the end of treatment (T2). Outcome indicators include measures of manual dexterity/upper limb performance, anxiety/depression, cognitive abilities, and patient-perceived outcomes. The analysis of Surface Plasmon Resonance imaging (SPRi) of serum exosome content, detected at T0, T1, and T2, will be correlated with variations in functional measures to verify the hypothesis that induction of neuroplasticity underlies any observed changes. Short- and medium-term effects on functional, psychological outcomes, as well as indicators of neuroinflammation and neural regeneration from serum analysis using innovative SPRi, will be compared among the 3 groups.
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)
盲法说明
The assessors conducting outcome evaluations and the operators performing statistical analysis will be blinded to the assignment group. Given the nature of the intervention, it will not be possible to maintain blinding regarding the treatment for both the therapists and the patients. To minimize bias related to patient non-blinding, however, no indications about the presumed superiority of one intervention over the others will be provided to the patients.
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
- •First ischemic or hemorrhagic stroke occurring at least 6 months prior.
- •Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77).
- •Willingness to participate in the study, with the provision of informed consent.
排除标准
- •Severe spastic hypertonia at the wrist and fingers (Modified Ashworth Scale equal to or greater than 3).
- •Orthopedic, rheumatological, and/or peripheral nervous system disorders affecting the paretic upper limb.
- •Neurodegenerative and neuromuscular disorders.
- •Acute pathologies affecting other body systems.
- •Severe cognitive, language, and behavioral disorders that significantly limit understanding and participation in the planned activities.
研究组 & 干预措施
Group A - Robotic therapy
Group A will undergo rehabilitative treatment using Gloreha Sinfonia hand robot, administered by a physical therapist experienced in robotic rehabilitation. The treatment will involve a set of progressively challenging exercises over the course of five weeks (3 sessions per week, each lasting 1 hour). The delivery of the treatment will be conducted in a face-to-face mode.
干预措施: Robotic therapy (Gloreha Sinfonia system) (Device)
Group B - Occupational Therapy
Group B will attend small group occupational therapy treatment (occupational therapist/patient ratio: 1:4). Subjects will attend a rehabilitative intervention lasting a total of 5 weeks, with three sessions per week, each lasting one hour, for a total of 15 hours of treatment.
干预措施: Occupational therapy (Other)
Group C - Control Group
Group C (control group) will receive advice from an experienced physiotherapist for a personalized exercise program to be independently carried out at their own residence. The program will focus on the upper limb and will be based on the assessment conducted at baseline.
干预措施: Control (Behavioral)
结局指标
主要结局
Manual dexterity
时间窗: At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).
Nine Hole Peg Test (Johansson et al., 2019) - MCID=32s (Sivan et al., 2011); MDC =32,8 sec; Percentage Change=54% (Chen et al., 2009)
次要结局
- Treatment satisfaction(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Shoulder/elbow/hand pain(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Participation(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Perceived change(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Upper limb motor skills(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Manual dexterity and activities of daily living abilities(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Anxiety and depression(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Cognitive functioning screening(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Neglect(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Health status and quality of life(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
- Neuroplasticity(At the baseline (beginning of the treatment - T0), at the end of the treatment (T1), and three months after the conclusion of the treatment (T2).)
研究者
Francesca Cecchi
Professor
University of Florence