A Randomized Controlled Single-Blind Crossover Trial on the Effects of Serious Games and Wearable Haptic Devices in the Rehabilitation of Children With Neuromotor Impairments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change From Baseline in Kinematic Metrics on Linear Path Tracking (LPT) and Reach-to-Grasp (RtG) Tasks for Dominant Hand at 4, 8, 16 and 24 weeks
研究概览
简要总结
The investigators proposed a controlled, single-blind, unicentric, crossover, randomized, clinical trial to test the effects of immersive virtual environments and wearable haptic devices in the rehabilitation of children with neuromotor impairments. In addition, the proposed approach was compared with respect to conventional therapy.
A sample of 8 participants was randomly divided into 2 groups and they attended one of the two therapeutic approach for 4 weeks before crossing over and inverting the therapy. Between the two interventions, there was a wash out period of 4 weeks.
The investigators assessed motor abilities of the children with validated clinical scales and motion analysis before/after each phase of the study (T0: baseline, T1: after 4 weeks, T2: after 8 weeks, T3: after 16 weeks, and T4: up to 24 weeks).
详细描述
A Randomized Controlled Crossover Trial was designed to examine the usability and effectiveness of serious games and wearable haptic interfaces in rehabilitation of children with neuromotor impairments. The ethics board of Tuscany Region and the Italian Ministry of Health approved this study. All parents freely accepted the participation of their children in the study and provided written informed consent.
The investigators recruited eight patients, both male and female, 3 children with Cerebral Palsy (CP) and 5 children with Developmental Dyspraxia (DD) (mean age = 10,30±2,88 years), who were currently receiving conventional therapy at Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, and eight Typically Developing children (TD, mean age = 9,60±2,61 years). All the patients were right-handed and they did not have previous experiences with Virtual Reality (VR) and/or haptic devices, while TD children have previously experienced with commercial video games.
Following recruitment, screening and consent and baseline assessments, participants are randomized to an order of VR-assisted rehabilitation (ISG-Group, Immediate Serious Games, or DSG-Group, Delayed Serious Games). Participants were setup in their first condition and were assessed at the end of the 4 week intervention. Participants were then set up in their second period for 4 weeks, again with assessment occurring at the end of the intervention. Among the two interventions, a wash out period of 4 weeks was inserted and children followed only cognitive therapy with no physical sessions.
The study protocol consisted of a total of 16 sessions with both VR-assisted and conventional rehabilitation (2 sessions per week for 4 weeks for 2 periods) and involved a familiarization and a training phase. The investigators adopted different established clinical scales for children with CP and DD in order to assess patients' abilities during the assessments. The investigators also selected metrics obtained from end-point (hand) kinematic data, including movement speed and accuracy, in order to have quantitative measurements of patients' motor abilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study was masked only for the medical doctor who performed the motor assessments with clinical scales: she did not follow the rehabilitation sessions.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a history of neuromotor disorders (CP or DD)
- •a maximum age of 18 years
- •a minimum ability to actively grasp an object
- •the ability to understand simple instructions
- •low to severe impairments of the upper limbs
排除标准
- •epileptic patients
- •severe deficit in sensory perception of upper limb
- •severe visual impairments
- •severe cognitive diseases
研究组 & 干预措施
ISG-Group (Immediate Serious Game)
Children in the ISG-Group first participated in the VR-assisted rehabilitation, which consisted in 8 sessions with immersive virtual environment and wearable haptic devices, and were then crossed over and followed during an intended duration of 6 hours of conventional therapy.
干预措施: Serious Game (Device)
ISG-Group (Immediate Serious Game)
Children in the ISG-Group first participated in the VR-assisted rehabilitation, which consisted in 8 sessions with immersive virtual environment and wearable haptic devices, and were then crossed over and followed during an intended duration of 6 hours of conventional therapy.
干预措施: Conventional Therapy (Other)
DSG-Group (Delayed Serious Game)
Children from DSG-Group were followed during an intended duration of 6 hours of conventional therapy before receiving VR-assisted rehabilitation with immersive virtual environment and wearable haptic devices.
干预措施: Serious Game (Device)
DSG-Group (Delayed Serious Game)
Children from DSG-Group were followed during an intended duration of 6 hours of conventional therapy before receiving VR-assisted rehabilitation with immersive virtual environment and wearable haptic devices.
干预措施: Conventional Therapy (Other)
结局指标
主要结局
Change From Baseline in Kinematic Metrics on Linear Path Tracking (LPT) and Reach-to-Grasp (RtG) Tasks for Dominant Hand at 4, 8, 16 and 24 weeks
时间窗: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
The evaluation task consisted of two reach-to-grasp tasks requiring forearm pronation or supination and three linear path tracking (forward and sideways). For the RtG task, the child was asked to flip a card protruding from an horizontal support. For the LPT, the child was seated in front of a desk with the hand positioned, at rest, close to the body on the sagittal plane. Then a target was put on the desk (always at the same distance from the starting position) and the child was asked to reach the target by moving the hand along a straight path. All tasks were performed with the preferred arm at self selected speed. The investigators then extracted kinematic metrics (movement speed, accuracy and smoothness) from end-point (hand) kinematic data.
Change From Baseline in Time Scores on Nine Hole Peg Test (9-HPT) for both Dominant and Non-Dominant Hands at 4, 8, 16 and 24 weeks
时间窗: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
Nine Hole Peg Test (9-HPT) is a brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The child is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the child picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded.
次要结局
- Number of Participants with Treatment-Related Adverse Events according to the CTCAE v.4.0(Up to 16 weeks)
研究者
Antonio Frisoli
Full Professor of Robotics and Mechanical Engineering
Scuola Superiore Sant'Anna di Pisa