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

NCT04309266 | Unknown FDA Device

• 1 other identifier: IRB P00032628
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (5)

• Canadian Occupational Performance Measure (COPM)

  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 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 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 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 at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).

Other Outcomes (7)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Upper Extremity Full Version

  Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).

• Quality of Upper Extremity Skills Test (QUEST)

  Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).

• Shriner's Hospital Upper Extremity Evaluation (SHUEE)

  Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).

Study Arms (1)

Robot Assisted Therapy with Metacognitive Skills Training

EXPERIMENTAL

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; Behavioral: Active Learning Protocol for Stroke

Interventions

Amadeo by Tyromotion DEVICE

Distal upper extremity/hand robot for robot-assisted therapy

Robot Assisted Therapy with Metacognitive Skills Training

Active Learning Protocol for Stroke BEHAVIORAL

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

Also known as: ALPS

Robot Assisted Therapy with Metacognitive Skills Training

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• MGH Institute of Health Professions: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Paresis; Cerebral Palsy; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Casey Rabideau, MS, OTR, BCP

  Department of Physical and Occupational Therapy Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 16, 2020
• Study Start: January 11, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Present (3/2020) - until study write-up is prepared for publishing (anticipated fall 2022).

Locations

US (1)