Understanding the Impact of Robot Assisted Therapy and Metacognitive Skills Training on Functional Performance for Children With Hemiparesis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Staff's Actual Competency of ALPS
研究概览
简要总结
The Occupational Therapy Department at Boston Children's Hospital is teaming up with MGH Institute of Health Professions to explore the benefits of using robot assisted therapy (Amadeo) and a problem solving approach (Active Learning Program for Stroke) to achieving functional goals for children ages 7-17 years old that have hemiparesis. The hope is to help participants make gains in both hand/arm skills and progress in everyday activities such as self-care, play, school and work. Participation will look like regular therapy with sessions 3 times weekly for 8 weeks. Each visit will include time for games on the Amadeo and time spent problem solving current activity challenges for each child. Families are encouraged to participate.
详细描述
Robot assisted therapy and Active Learning Program for Stroke (ALPS) are unique interventions that are feasible and effective for individuals with neuromotor impairments. To the best of our knowledge, this is a novel intervention approach and thus there are no preliminary studies to acknowledge that reference this combined technique. There have been studies which evaluated the Amadeo and metacognitive approaches in isolation, but not combined.
The goal of this pilot study is to better understand the impact of a combined approach using both robot assisted therapy and metacognitive skills training through ALPS on the functional performance outcomes of children with hemiparesis. Our primary aim is to evaluate the feasibility of this pilot study intervention as measured by adequate recruitment of necessary population, participant attendance to scheduled sessions, participant adherence to home program and clinician competence/adherence with protocol administration. Our secondary aim is to understand the preliminary impact of a combined approach to intervention involving robot-assisted therapy and a metacognitive strategy training ALPS on upper limb motor skills and function of children with hemiparesis. It is hypothesized that utilizing this combined bottom-up and top-down approach will be a feasible option for intervention and that preliminary outcomes will be promising. If successful, this project has the potential to improve rehabilitation and habilitation outcomes of children with hemiparesis.
This study will be set as a prospective pilot study with pre- and post-intervention and one month follow-up evaluation. Study procedures will occur within Boston Children's Hospital's Department of Physical and Occupational Therapy Service. For the duration of this trial, participants will not be allowed to participate in additional occupational therapy intervention.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child must be between 7 and 17 years of age at the start of the study.
- •Child must have hemiparesis with at least partial active grasp and release.
- •Child must be able to follow multi-step commands.
- •Child must have a caregiver available who can assist with implementation of home exercise program.
- •Child must speak English.
- •Child must have hemiparesis caused by cerebral vascular accident.
- •Child must have adequate insurance to cover evaluation, re-evaluations, and intervention, as this study will be billed to participants' insurance.
排除标准
- •Child must not have received botulinum toxin or phenol injections within 4 months of and/or during intervention.
- •Child must have tone less than 3/4 on Modified Ashworth Scale.
- •Child must not be considered legally blind.
- •Child must not have contraindications for use of robot assisted device (ie. recent fracture or skin lesion).
- •Child must not be non-verbal.
- •Child must have not had reconstructive surgery to the affected upper extremity within the last year.
- •Child must not be receiving active oncology plan of care.
结局指标
主要结局
Staff's Actual Competency of ALPS
时间窗: Determined at the conclusion of the study, approximately 2 years
Measured by fidelity checklist.
Staff's Actual Competency of Hemiparesis
时间窗: Every 3 months until conclusion of the study, up to 2 years
Measured by routine audits.
Staff's Perceived Competency of ALPS
时间窗: Determined at the conclusion of the study, approximately 2 years
Measured by post-training survey.
Implementation of Intervention
时间窗: Determined at the conclusion of the study, approximately 2 years
Was the recommended frequency/duration of Amadeo and ALPS provided to participants?
Patient Recruitment
时间窗: Determined at the conclusion of the study, approximately 2 years
Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained?
Staff's Actual Competency of Amadeo
时间窗: Determined at the conclusion of the study, approximately 2 years
Measured by fidelity checklist.
Staff's Perceived Competency of Hemiparesis
时间窗: Determined at the conclusion of the study, approximately 2 years
Measured by a post-training survey.
Staff's Perceived Competency of Amadeo
时间窗: Determined at the conclusion of the study, approximately 2 years
Measured by post-training survey.
次要结局
- Box & Blocks(Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).)
- 9 Hole Peg Test(Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).)
- Canadian Occupational Performance Measure (COPM)(Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).)
- Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT): Activities of Daily Living and Social/Cognitive Domains(Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).)
- Jebsen Hand Function Test(Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).)
研究者
Casey Rabideau
Primary Investigator
Boston Children's Hospital