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

NCT ID: NCT04309266

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2024-01-31

Brief 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

Keywords

arm weakness; cerebral palsy; stroke; in utero; cognition; occupational therapy; robot therapy; robot assisted therapy; metacognition; children; pediatric; Amadeo; arm; upper extremity; Tyromotion; ALPS; motor learning; rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot Assisted Therapy with Metacognitive Skills Training

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

Group Type: EXPERIMENTAL

Amadeo by Tyromotion

Intervention Type: DEVICE

Distal upper extremity/hand robot for robot-assisted therapy

Active Learning Protocol for Stroke

Intervention Type: BEHAVIORAL

Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program.

Interventions

Amadeo by Tyromotion

Distal upper extremity/hand robot for robot-assisted therapy

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ALPS

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MGH Institute of Health Professions

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Casey Rabideau

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Casey Rabideau, MS, OTR, BCP

Role: PRINCIPAL_INVESTIGATOR

Department of Physical and Occupational Therapy Service

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB P00032628

Identifier Type: -

Identifier Source: org_study_id