Innovative Use of Wereable Technology for Improving Functionality in Children with Unilateral Cerebral Palsy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bimanual performance/functional hand use
研究概览
简要总结
The project is configured as a national interventional study that aims to determine the effectiveness of an intervention strategy using wearable technology, tailored to improve function (WeFun-wearable), on the spontaneous use of the affected upper extremity, activities of daily living and the participation in children with unilateral cerebral palsy.
详细描述
Cerebral palsy represents the most common paediatric neurological disorders. Unilateral cerebral palsy (UCP) subtype is the most frequent, accounting for about 0.6-1 per 1000 live births. Many children with UCP experience upper limb dysfunction, which is often more pronounced than that on lower extremity limitation. Rehabilitation strategies on the affected upper limb are of paramount importance to diminish limitations, especially those that seek to improve independence and wellbeing. These strategies are often provided through technology, which got into the clinics spotlight years ago, after extensive innovation-driven and knowledge research.
However, technology development has not reached its tops and technology solutions will drive the optimization of scientific evidence-based rehabilitation strategies. In this project, we use scientific knowledge acquired in our laboratory regarding the validation of new technologies to evaluate and treat movement disorders. Specifically, an unprecedented wearable will be used that could assess movement and complement intervention to influence function to such an extent that it would ultimately improve participation and quality of life for children with UCP.
WeFun proposes a home-based multimodal technology-based training, related to the practice of activities of daily life, to improve the use of the affected upper limb. WeFun wearable allows daily assessment of the amount of movement, in combination with training of upper limb movements and daily routines for children with CP. Our hypothesis is that a wearable technology to improve function, the We-Fun-wearable, could be an effective tool for the assessment and approach of the upper limb in children with CP.
This study has the potential to establish a new evidence-based and cost-effective therapy, accessible to children with cerebral palsy and their families, so that a digital solution can be provided for a vulnerable group: children with disabilities.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation in the experimental and control group is blinded for children, families and researchers who assesses. Outcome measures are blinded for the researcher doing the intervention. Researchers doing the analysis are blinded to the conditions.
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of UCP.
- •Children aged between 3 and 8 years old.
- •Children rated on levels I to III on the Manual Ability Classification System (MACS).
排除标准
- •Botulinum toxin injection or surgical interventions in the upper limb within 6 months prior to study entry.
- •Medical complications non-controlled that would interfere with study participation (e.g., not controlled epilepsy).
- •Predominantly athetoid or dystonia movement patterns.
- •Insufficient cognitive level to follow instructions,
- •Non-corrected marked visual impairments.
- •Families can be retired from the study after starting if:
- •Families don't assist or don't collaborate in the weekly sessions with the reference person.
- •Wearable activity if presumably lower than expected (few recordings of activity, <20%).
- •Families don't provide feedback about daily sessions through the satisfaction system in the app/registration sheet.
研究组 & 干预措施
1 month daily routine program with wefun-weareable activated
Children will follow a daily routine program based on goals set by families, which will be initiated by the wearable. Children in the experimental group will have the wearable's experimental movement functions activated.
干预措施: WeFun-wearable activated (Device)
1 month daily routine program with wefun-wearable desactivated
Children will follow a daily routine program based on goals set by families, which will be initiated by the wearable. Children in the control group will not have experimental functions in their wearables.
干预措施: WeFun-wearable desactivated (Device)
结局指标
主要结局
Bimanual performance/functional hand use
时间窗: Baseline, immediately after the intervention and after 2 months follow-up
The Assisting Hand Assessment (AHA) evaluates the spontaneous use of the more affected upper limb during bimanual activities. For these assessments a semi-structured play session with standardized toys and materials, that require the use of both hands, is performed and video-recorded. Subsequently, 20 items are scored in a rating range of 4 points, and the sum of scores in AHA may vary between 22 and 88 points. Through Rasch analysis this ordinal scale is transformed into AHA units ranging from 0 to 100 to obtain the final score. The AHA has shown to be a reliable and valid assessment for children and adolescents with unilateral cerebral palsy.
次要结局
- Sociodemographic variables(Baseline, immediately after the intervention and after 2 months follow-up)
- Upper Extremity Use (UEU) - WeFUN-wearable measure(Baseline, during intervention period, immediately after the intervention and after 2 months follow-up)
- Asymmetry Index (AI) - WeFUN-wearable measure(Baseline, immediately after the intervention and after 2 months follow-up)
- Grip strength(Baseline, immediately after the intervention and after 2 months follow-up)
- Static motor fatigability(Baseline, immediately after the intervention and after 2 months follow-up)
- Dynamic motor fatigability(Baseline, immediately after the intervention and after 2 months follow-up)
- Hand Dexetrity(Baseline, immediately after the intervention and after 2 months follow-up)
- Participation measures(Baseline, immediately after the intervention and after 2 months follow-up)
- Quality of life measures(Baseline, immediately after the intervention and after 2 months follow-up)
- Attention measures(Baseline, immediately after the intervention and after 2 months follow-up)
- Self-perceived occupational performance(Baseline, immediately after the intervention and after 2 months follow-up)
- Goal attainment(Baseline, immediately after the intervention and after 2 months follow-up)
- Usability measures(immediately after the intervention)
- Adherence measures(immediately after the intervention)