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

Boston Children's Hospital

Status: Active, not recruiting

Conditions: Hemiparesis;Poststroke/CVA; Hemiparesis; Hemiplegic Cerebral Palsy

Treatments: Device: Amadeo by Tyromotion; Behavioral: Active Learning Protocol for Stroke

Study type: Interventional

Funder types: Other

Identifiers

NCT04309266

IRB P00032628

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Robot Assisted Therapy with Metacognitive Skills Training

Experimental group

Description:

All participants will be enrolled in the single arm of this study, where they will receive robot assisted therapy combined with metacognitive skills training.

Treatment:

Behavioral: Active Learning Protocol for Stroke

Device: Amadeo by Tyromotion