NCT04309266

The Impact of Robot Assisted Therapy and Metacognitive Skills Training for Children With Hemiparesis

Understanding the Impact of Robot Assisted Therapy and Metacognitive Skills Training on Functional Performance for Children With Hemiparesis: A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hemiparesis
• Hemiplegic Cerebral Palsy
• Hemiparesis;Poststroke/CVA

Interventions

Type	Name	Description
DEVICE	Amadeo by Tyromotion	Distal upper extremity/hand robot for robot-assisted therapy
BEHAVIORAL	Active Learning Protocol for Stroke	Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program.

Timeline

• Start date: 2021-01-11
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2020-03-16
• Last updated: 2023-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study