跳至主要内容
临床试验/NCT04298411
NCT04298411已完成不适用

Project Falcon: Exploring a Virtual Reality-based Video Game With Haptic Feedback for Sensory-motor Rehabilitation of Young People With Cerebral Palsy

Holland Bloorview Kids Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Change in Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

This study seeks to 1) adapt a low-cost controller, the Novint Falcon, and a set of video games that would provide rehabilitative feedback for young people with cerebral palsy, and 2) explore feasibility of the Falcon system and it's effect on upper limb and hand function.

详细描述

Motivation: Children with cerebral palsy (CP) experience various challenges in upper limb motor function (e.g. muscle weakness, impaired manual abilities, spasticity, ataxia, athetosis and/or dystonia) that can impede their activities and participation in daily life. Rehabilitation strategies to support children with CP in achieving improved upper limb control target these areas through strengthening, endurance building, and motor learning activities. Neuroplasticity and motor learning are promoted by repetitive practice in a motivating and rewarding environment, immediate feedback on performance, and use of tasks with appropriate complexity that is increased as progress is made. Many elements of video games (e.g. progressive difficulty levels, engaging game play) may support motor learning and early evidence suggests that interactive computer play is likely effective for improving lower limb function with some promising indications for upper limb rehabilitation. The majority of evidence comes from studies that have used commercial gaming systems where children interact with virtual objects on the screen via their movements. These systems, however, do not provide haptic feedback, which may aid in motor learning and the transference of skills practiced in virtual environments to real-life.

The Novint Falcon is a low-cost, three degree-of-freedom video game controller that can provide force and tactile feedback during game play. The three motors that enable the provision of haptic feedback can also be used to assist movements. A software development kit is available and enables custom design of games and applications. One previous study investigated this device in adults for stroke rehabilitation. While promising, one drawback identified was that the available mini-games did not practice therapeutically relevant movements.

Objective: Considering the upper limb motor challenges experienced by children with CP and the potential of the Novint Falcon to assist in their rehabilitation, research is needed to develop challenging video games adapted for this controller. The objectives of this proposal are 1) to adapt a low-cost haptic controller and compile a set of video games that provide tactile and force feedback for the rehabilitation of young people with CP, and 2) to explore the feasibility of the system and the effects on upper limb and hand function.

Methods: In pursuit of these two objectives:

  1. Existing mini-games will be reviewed in partnership with therapists to identify promising games. Thereafter, new mini-games will be designed as needed to meet with therapeutic goals identified by the therapists. The design of the controller's grip will then be reviewed via a participatory design approach that engages both therapists and children with CP. New grips will be created as needed.
  2. The resulting system will be evaluated in a clinic setting by children with hemiplegic CP (ages 7 to 16 years; n=14; 7/site) at Holland Bloorview Kids Rehabilitation Hospital and Institut de réadaptation en déficience physique de Québec. Each child with CP will take part in one initial assessment session, 12 one-hour rehabilitation sessions over 12 weeks during which they will play games developed for the Novint Falcon, and one final assessment session. Independent evaluators will assess the children with CP before (two baseline measurements will be established) and after the 12-week intervention. The outcomes of interest include: Canadian Occupational Therapy Performance Measure, Quality of Upper Extremity Skills Test, sensory profile, grip strength, and upper extremity range of motion. Further, child participants will complete the Physical Activity Enjoyment Scale, while therapists will complete the System Usability scale.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of hemiplegic cerebral palsy
  • •Level I to III on the Manual Abilities Classification System (MACS)
  • •Ability to understand and communicate in English (Holland Bloorview site) or French (IRDPQ site) at a grade 2 level or higher

排除标准

  • •Received Botulinum Toxin in the most recent 3 months
  • •History of epilepsy
  • •Past experience of an injury or disability that would render therapy unsafe
  • •Visual, cognitive or auditory disabilities that interfere with the ICP

研究组 & 干预措施

Experimental Arm

Experimental

Participants will take part in 12 one-hour rehabilitation sessions over 12 weeks in the clinic at Holland Bloorview Kids Rehabilitation Hospital and Institut de réadaptation en déficience physique de Québec, during which they will play games developed for the Novint Falcon.

干预措施: Falcon (Device)

结局指标

主要结局

Change in Canadian Occupational Performance Measure (COPM)

时间窗: Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).

The Canadian Occupational Performance Measure evaluates changes in perceived function and satisfaction of performance in self-identified goal areas. The child and parent work together with the therapist to identify 1-3 goals of interest. For each goal area, the child/parent ranks its importance, performance and satisfaction on a scale of 1-10. A higher rating indicates a more positive outcome.

次要结局

  • Change in Children's Hand-use Experience Questionnaire (CHEQ)(Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).)
  • Change in Grip Strength(Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).)
  • active/passive range of motion(Measured at 0 weeks (pre-intervention) and 12 weeks (post-intervention).)
  • Change in Shortened Physical Activity Enjoyment Scale (S-PACES)(Measured at 1 week, 6 weeks, and 12 weeks.)
  • Change in the answers reported in custom feedback questionnaires(Measured at 1 week, 6 weeks, and 12 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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