The Impact of Robot Assisted Therapy and Metacognitive Skills Training for Children With Hemiparesis
Primary Purpose
Hemiparesis, Hemiplegic Cerebral Palsy, Hemiparesis;Poststroke/CVA
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amadeo by Tyromotion
Active Learning Protocol for Stroke
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring 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
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.
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot Assisted Therapy with Metacognitive Skills Training
Arm Description
All participants will be enrolled in the single arm of this study, where they will receive robot assisted therapy combined with metacognitive skills training.
Outcomes
Primary Outcome Measures
Patient Recruitment
Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained?
Implementation of Intervention
Was the recommended frequency/duration of Amadeo and ALPS provided to participants?
Implementation of Intervention
Did patients adhere to daily home programming? - At least 80% compliance will be deemed successful.
Staff's Perceived Competency of Hemiparesis
Measured by a post-training survey.
Staff's Actual Competency of Hemiparesis
Measured by routine audits.
Staff's Perceived Competency of Amadeo
Measured by post-training survey.
Staff's Actual Competency of Amadeo
Measured by routine audits.
Staff's Actual Competency of Amadeo
Measured by fidelity checklist.
Staff's Perceived Competency of ALPS
Measured by post-training survey.
Staff's Actual Competency of ALPS
Measured by routine audits.
Staff's Actual Competency of ALPS
Measured by fidelity checklist.
Secondary Outcome Measures
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
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.
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
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
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
Full Information
NCT ID
NCT04309266
First Posted
March 4, 2020
Last Updated
January 11, 2022
Sponsor
Boston Children's Hospital
Collaborators
MGH Institute of Health Professions
1. Study Identification
Unique Protocol Identification Number
NCT04309266
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
MGH Institute of Health Professions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot Assisted Therapy with Metacognitive Skills Training
Arm Type
Experimental
Arm Description
All participants will be enrolled in the single arm of this study, where they will receive robot assisted therapy combined with metacognitive skills training.
Intervention Type
Device
Intervention Name(s)
Amadeo by Tyromotion
Intervention Description
Distal upper extremity/hand robot for robot-assisted therapy
Intervention Type
Behavioral
Intervention Name(s)
Active Learning Protocol for Stroke
Other Intervention Name(s)
ALPS
Intervention Description
Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program.
Primary Outcome Measure Information:
Title
Patient Recruitment
Description
Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained?
Time Frame
Determined at the conclusion of the study, approximately 2 years
Title
Implementation of Intervention
Description
Was the recommended frequency/duration of Amadeo and ALPS provided to participants?
Time Frame
Determined at the conclusion of the study, approximately 2 years
Title
Implementation of Intervention
Description
Did patients adhere to daily home programming? - At least 80% compliance will be deemed successful.
Time Frame
Determined at the conclusion of the study, approximately 2 years
Title
Staff's Perceived Competency of Hemiparesis
Description
Measured by a post-training survey.
Time Frame
Determined at the conclusion of the study, approximately 2 years
Title
Staff's Actual Competency of Hemiparesis
Description
Measured by routine audits.
Time Frame
Every 3 months until conclusion of the study, up to 2 years
Title
Staff's Perceived Competency of Amadeo
Description
Measured by post-training survey.
Time Frame
Determined at the conclusion of the study, approximately 2 years
Title
Staff's Actual Competency of Amadeo
Description
Measured by routine audits.
Time Frame
Every 3 months until conclusion of the study, up to 2 years
Title
Staff's Actual Competency of Amadeo
Description
Measured by fidelity checklist.
Time Frame
Determined at the conclusion of the study, approximately 2 years
Title
Staff's Perceived Competency of ALPS
Description
Measured by post-training survey.
Time Frame
Determined at the conclusion of the study, approximately 2 years
Title
Staff's Actual Competency of ALPS
Description
Measured by routine audits.
Time Frame
Every 3 months until conclusion of the study, up to 2 years
Title
Staff's Actual Competency of ALPS
Description
Measured by fidelity checklist.
Time Frame
Determined at the conclusion of the study, approximately 2 years
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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
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).
Title
Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT): Activities of Daily Living and Social/Cognitive Domains
Description
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.
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).
Title
Box & Blocks
Description
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
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).
Title
Jebsen Hand Function Test
Description
Administered to all participants
Provides data regarding the uni-manual skills required for ADLs.
Scores are timed measurements
Administration time = ~15-30 minutes
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).
Title
9 Hole Peg Test
Description
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
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).
Other Pre-specified Outcome Measures:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Upper Extremity Full Version
Description
Administered to all participants, completed by parent/guardian
Provides data for a participant's level of upper extremity function within a variety of functional tasks including ADLS, Instrumental Activities of Daily Living (IADLs), Education.
Parent/Child questionnaire
All items rated on scale of either 1-5 or 1-4, with higher scores signifying higher levels of independence.
Administration time = ~15 minutes
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).
Title
Quality of Upper Extremity Skills Test (QUEST)
Description
All participants evaluated for subsections A (dissociated movements) and B (Grasps)
Provides data regarding dissociated movement and grasp patterns
No formal score acquired within this study. QUEST will be used as a way to have universal language for grasp and pinch between providers.
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).
Title
Shriner's Hospital Upper Extremity Evaluation (SHUEE)
Description
Administered to all participants
Provides data regarding the spontaneous use of a hemiparetic upper extremity and the dynamic segmental alignment of the extremity while performing tasks on demand.
Scores are calculated in percentiles.
Spontaneous Functional Analysis items scored on scale of 0-5, with higher scores signifying more spontaneous use of the affected arm.
Dynamic Positional Analysis items ranked on scale of 0-3, with higher scores signifying optimal alignment of the respective arm segment (elbow, forearm, wrist, finger, thumb).
Grasp and Release Analysis items scored on scale of 0-3, with higher scores signifying optimal alignment of the wrist in grasp/release tasks.
Administration time = ~15 minutes
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).
Title
Pain Scale
Description
All participants evaluated
Provides data on participant's current pain level.
Ranked using 0-10 numeric scale, with higher rankings signifying increased level of pain.
Administration time = ~1 minute
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).
Title
Stereognosis Sensory Testing
Description
All participants evaluated
Measures child's ability to perceive and recognize an object in hand. Scored in percentile correct.
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).
Title
Two-Point Discrimination Sensory Testing
Description
All participants evaluated
Two-Point Discrimination - ability to discern that two nearby objects touching the skin are truly two distinct points, not one. Score in percentile correct.
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).
Title
Active and Passive Range of Motion
Description
All participants evaluated for shoulder flexion, abduction, external rotation and internal rotation, elbow flexion/extension, forearm supination/pronation, wrist flexion/extension and gross grasp/release measurements.
Measured with goniometer in degrees
Administration time = ~15 minutes.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casey Rabideau, MS, OTR, BCP
Organizational Affiliation
Department of Physical and Occupational Therapy Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data including patient age and performance on outcome measures will be shared with Susan Fasoli, ScD, OTR/L at MGH Institute of Health Professions via RedCap online database. Susan will assist with data analysis and write-up of findings.
IPD Sharing Time Frame
Present (3/2020) - until study write-up is prepared for publishing (anticipated fall 2022).
Learn more about this trial
The Impact of Robot Assisted Therapy and Metacognitive Skills Training for Children With Hemiparesis
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