Clinical trial NCT04309266: The Impact of Robot Assisted Therapy and Metacognitive Skills Training for Children With Hemiparesis
Official title: Understanding the Impact of Robot Assisted Therapy and Metacognitive Skills Training on Functional Performance for Children With Hemiparesis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: MGH Institute of Health Professions
First posted: 2020-03-16
Enrollment: 2
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient Recruitment
timeFrame: Determined at the conclusion of the study, approximately 2 years
measure: Implementation of Intervention
timeFrame: Determined at the conclusion of the study, approximately 2 years
measure: Implementation of Intervention
timeFrame: Determined at the conclusion of the study, approximately 2 years
measure: Staff's Perceived Competency of Hemiparesis
timeFrame: Determined at the conclusion of the study, approximately 2 years
measure: Staff's Actual Competency of Hemiparesis
timeFrame: Every 3 months until conclusion of the study, up to 2 years
measure: Staff's Perceived Competency of Amadeo
timeFrame: Determined at the conclusion of the study, approximately 2 years
measure: Staff's Actual Competency of Amadeo
timeFrame: Every 3 months until conclusion of the study, up to 2 years
measure: Staff's Actual Competency of Amadeo
timeFrame: Determined at the conclusion of the study, approximately 2 years
measure: Staff's Perceived Competency of ALPS
timeFrame: Determined at the conclusion of the study, approximately 2 years
measure: Staff's Actual Competency of ALPS
timeFrame: Every 3 months until conclusion of the study, up to 2 years
measure: Staff's Actual Competency of ALPS
timeFrame: Determined at the conclusion of the study, approximately 2 years
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT): Activities of Daily Living and Social/Cognitive Domains
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Box & Blocks
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Jebsen Hand Function Test
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: 9 Hole Peg Test
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Other outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Upper Extremity Full Version
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Quality of Upper Extremity Skills Test (QUEST)
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Shriner's Hospital Upper Extremity Evaluation (SHUEE)
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Pain Scale
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Stereognosis Sensory Testing
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Two-Point Discrimination Sensory Testing
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
measure: Active and Passive Range of Motion
timeFrame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Department of Physical and Occupational Therapy Service
name: Casey Rabideau, MS, OTR, BCP
role: PRINCIPAL_INVESTIGATOR
References: