Collaborative Development of a Virtual Reality Scenario, Integrated Into a Robotic Upper Limb Rehabilitation Device, for the Treatment of Unilateral Spatial Negligence (NSU) Through Mutisensory Stimulation: Feasibility and Usability Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Usability of the device
研究概览
简要总结
The goal of this pilot clinical trial is to develop an integrated motor and cognitive rehabilitation program and evaluate the usability and acceptability of a new virtual reality scenario designed for the MOTORE device. This study will focus on the rehabilitation of the upper limbs in post-stroke patients with plegia and left-sided hemi-inattention. The main questions it aims to answer are:
- The evaluation of the usability and acceptability of the newly developed scenario
- The evaluation of the effects of the new scenario on patients' hemi-inattention
- The evaluation of changes in upper limb functional parameters
Participants will undergo a total of 13 rehabilitation sessions, each lasting 45 minutes, using the new scenario, including an initial and final assessment.
详细描述
Stroke in the right hemisphere can provoke both motor and cognitive symptoms. Hemi-inattention is a cognitive deficit typical of right hemispheric damage, with an incidence ranging from 12% to 95%. This deficit can manifest as difficulty in detecting and responding to stimuli from the left side of space, without any motor or sensory impairments that could justify the deficit. Hemi-inattention is usually associated with lesions in the inferior and superior parietal areas and, sometimes, in parts of the frontal area and the white matter connecting the parietal to the prefrontal areas. Hemi-inattention significantly compromises patients' quality of life and can negatively impact both motor and cognitive rehabilitation outcomes.
According to the theory of premotor spatial attention, brain attention and motor circuits are closely connected. Thus, it is possible to hypothesize that somatosensory activation in the contralesional space could stimulate the neural networks responsible for spatial representation and the conscious perception of stimuli. Some studies have attempted to verify this hypothesis by developing ad-hoc rehabilitation programs based on these theoretical principles. These studies can be divided into:
Studies investigating upper limb active mobilization, which require the activation of residual motor capabilities Studies investigating upper limb passive mobilization. It is widely accepted that hemi-inattention is a multisensory deficit, i.e., involving several sensory channels, and that a rehabilitation program based on joint stimulation of different channels can be effective.
Robot-assisted rehabilitation for the upper limbs, especially in hemiparetic patients, has gained growing interest in recent years, given the possibility of intensive treatment while still ensuring patient safety [8-9]. However, few studies have focused on the use of robotic devices, whose training modality often involves serious games, on cognitive aspects, particularly on hemi-inattention.
Even though preliminary and based on small sample sizes, these studies suggest a potential advantage of integrated cognitive and motor intervention for the rehabilitation of the upper limb and hemi-inattention. Indeed, the use of serious games and virtual reality scenarios can promote a synergistic effect of motor and cognitive stimulation. Furthermore, robotic rehabilitation can offer additional advantages, such as the "game effect," the ability to adapt the exercise difficulty level to the patient's performance, and the possibility of providing real-time feedback to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a diagnosis of right hemispheric stroke
- •Presence of a diagnosis of hemi-inattention (Apple test)
- •Presence of left hemiplegia (Fugl-Meyer Assessment Upper Limb ≤58)
- •Adjusted Montreal Cognitive Assessment <20
- •Written informed consent
排除标准
- •Presence of cognitive decline prior to the event
- •Presence of previous stroke events
- •Presence of osteoarticular rigidity (e.g., ankylosis, functional limitations with traumatic or degenerative origin) or spasticity in the affected upper limb (Modified Ashworth Scale ≥3 on shoulder, elbow, or wrist)
- •Inability to maintain a sitting position
- •Presence of severe visual disabilities
- •Recent injection of botulinum toxin in the upper limb or planned injection of botulinum toxin during the study period
- •Orthopaedic, neurological, or psychiatric disorders that could interfere with the study procedures and motor or cognitive assessments
- •Unstable fractures of the upper limb
- •Severe osteoporosis
- •Skin lesions on the upper limb
研究组 & 干预措施
Upper limbs robotic intervention
The intervention, which includes the upper limb robotic device MOTORE+ and the new scenario, consists of:
- Enrollment (Session 1): assessment of the inclusion criteria. Informed consent is obtained.
- Baseline evaluation (Session 2): assessment of upper limb function and hemi-inattention. Additionally, robotic performance parameters are collected.
- Training sessions (Sessions 3-12): these are the actual training sessions with the robotic device. Each session consists of three phases.
In the first phase, the therapist provides the patient with the necessary information for the session.
In the second phase, patients complete a pre-scenario session, during which the robotic parameters are adjusted.
In the third phase, the scenario is used for motor and cognitive training.
-Final evaluation (Session 13): final functional, clinical, and psychological assessments.
The sessions are conducted five times per week, each lasting 45 minutes.
干预措施: Upper-limb planar robotic intervention (Device)
结局指标
主要结局
Usability of the device
时间窗: Evaluated at session 12 (after the treatment) at an average of 2 weeks
System Usability Scale (SUS)
Acceptability of the device for the operator
时间窗: Evaluated at session 12 (after the treatment) at an average of 2 weeks
Self-designed qualitative checklist
次要结局
- Variation of symptoms connected to hemi-inattention(Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment))
- Functional direct effect of the device(Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment))
