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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Amadeo by Tyromotion
* Behavioral: Active Learning Protocol for Stroke


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot Assisted Therapy with Metacognitive Skills Training<br>All participants will be enrolled in the single arm of this study, where they will receive robot assisted therapy combined with metacognitive skills training. | Device: Amadeo by Tyromotion<br>* Distal upper extremity/hand robot for robot-assisted therapy<br>Behavioral: Active Learning Protocol for Stroke<br>* Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program.<br>* Other names: ALPS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Recruitment | Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained? | Determined at the conclusion of the study, approximately 2 years | 
| Implementation of Intervention | Was the recommended frequency/duration of Amadeo and ALPS provided to participants? | Determined at the conclusion of the study, approximately 2 years | 
| Implementation of Intervention | Did patients adhere to daily home programming? - At least 80% compliance will be deemed successful. | Determined at the conclusion of the study, approximately 2 years | 
| Staff's Perceived Competency of Hemiparesis | Measured by a post-training survey. | Determined at the conclusion of the study, approximately 2 years | 
| Staff's Actual Competency of Hemiparesis | Measured by routine audits. | Every 3 months until conclusion of the study, up to 2 years | 
| Staff's Perceived Competency of Amadeo | Measured by post-training survey. | Determined at the conclusion of the study, approximately 2 years | 
| Staff's Actual Competency of Amadeo | Measured by routine audits. | Every 3 months until conclusion of the study, up to 2 years | 
| Staff's Actual Competency of Amadeo | Measured by fidelity checklist. | Determined at the conclusion of the study, approximately 2 years | 
| Staff's Perceived Competency of ALPS | Measured by post-training survey. | Determined at the conclusion of the study, approximately 2 years | 
| Staff's Actual Competency of ALPS | Measured by routine audits. | Every 3 months until conclusion of the study, up to 2 years | 
| Staff's Actual Competency of ALPS | Measured by fidelity checklist. | Determined at the conclusion of the study, approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure (COPM) | Administered to all participants. The parent/caregiver and child will collaboratively develop goal priority areas. Both the parent/caregiver and child will then separately score performance and satisfaction in each identified area so that both parent and child perception are obtained. Provides data for participant's self-perceived performance capacity and satisfaction with performance on self-determined functional goal areas. Performance and Satisfaction are ranked on a scale of 1-10, with higher scores signifying higher self-perceived performance/satisfaction in personally identified meaningful activities. Parent/Child interview with performance/satisfaction score rankings completed Administration time =  15 minutes | 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 to all participants. To be completed by child's parent/caregiver. Provides data for a participant's level of independence with Activities of Daily Living (ADLs) Parent/Child questionnaire Items in Activities of Daily Living and Social/Cognitive domains scored on scale of 1-4, with higher scores signifying increased ease in tasks. Administration time =  15 minutes, can be completed prior to clinic evaluation. | Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). | 
| Box & Blocks | Administered to all participants Provides data regarding a child's gross manual dexterity Measures number of blocks transferred from one compartment to the next in 60 seconds. Administration time =  10 minutes | 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 to all participants Provides data regarding the uni-manual skills required for ADLs. Scores are timed measurements Administration time =  15-30 minutes | 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 to participants who are successful to pick up small manipulatives as part of Jebsen Provides data regarding fine manual dexterity Scores are timed measurements. Participants will be allowed maximum 4 minutes for trial with hemiparetic upper extremity. Administration time =  10 minutes | Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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