- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309266
The Impact of Robot Assisted Therapy and Metacognitive Skills Training for Children With Hemiparesis
Understanding the Impact of Robot Assisted Therapy and Metacognitive Skills Training on Functional Performance for Children With Hemiparesis: A Pilot Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Distal upper extremity/hand robot for robot-assisted therapy
Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities.
Also includes a home program.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Recruitment
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained?
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Determined at the conclusion of the study, approximately 2 years
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Implementation of Intervention
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Was the recommended frequency/duration of Amadeo and ALPS provided to participants?
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Determined at the conclusion of the study, approximately 2 years
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Implementation of Intervention
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Did patients adhere to daily home programming?
- At least 80% compliance will be deemed successful.
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Determined at the conclusion of the study, approximately 2 years
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Staff's Perceived Competency of Hemiparesis
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Measured by a post-training survey.
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Determined at the conclusion of the study, approximately 2 years
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Staff's Actual Competency of Hemiparesis
Time Frame: Every 3 months until conclusion of the study, up to 2 years
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Measured by routine audits.
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Every 3 months until conclusion of the study, up to 2 years
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Staff's Perceived Competency of Amadeo
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Measured by post-training survey.
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Determined at the conclusion of the study, approximately 2 years
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Staff's Actual Competency of Amadeo
Time Frame: Every 3 months until conclusion of the study, up to 2 years
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Measured by routine audits.
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Every 3 months until conclusion of the study, up to 2 years
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Staff's Actual Competency of Amadeo
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Measured by fidelity checklist.
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Determined at the conclusion of the study, approximately 2 years
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Staff's Perceived Competency of ALPS
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Measured by post-training survey.
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Determined at the conclusion of the study, approximately 2 years
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Staff's Actual Competency of ALPS
Time Frame: Every 3 months until conclusion of the study, up to 2 years
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Measured by routine audits.
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Every 3 months until conclusion of the study, up to 2 years
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Staff's Actual Competency of ALPS
Time Frame: Determined at the conclusion of the study, approximately 2 years
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Measured by fidelity checklist.
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Determined at the conclusion of the study, approximately 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canadian Occupational Performance Measure (COPM)
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT): Activities of Daily Living and Social/Cognitive Domains
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Box & Blocks
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Jebsen Hand Function Test
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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9 Hole Peg Test
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Upper Extremity Full Version
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Quality of Upper Extremity Skills Test (QUEST)
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Shriner's Hospital Upper Extremity Evaluation (SHUEE)
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Pain Scale
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Stereognosis Sensory Testing
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Two-Point Discrimination Sensory Testing
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Active and Passive Range of Motion
Time Frame: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Casey Rabideau, MS, OTR, BCP, Department of Physical and Occupational Therapy Service
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB P00032628
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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