HemiparesisNCT04309266
The Impact of Robot Assisted Therapy and Metacognitive Skills Training for Children With Hemiparesis
A study testing Amadeo by Tyromotion and Active Learning Protocol for Stroke in people with Hemiparesis and Hemiplegic Cerebral Palsy, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Hemiparesis, Hemiplegic Cerebral Palsy, Hemiparesis;Poststroke/CVA
- What is being tested?
- Amadeo by Tyromotion and Active Learning Protocol for Stroke
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Understanding the Impact of Robot Assisted Therapy and Metacognitive Skills Training on Functional Performance for Children With Hemiparesis: A Pilot Study
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.
Read the 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.
- Being tested
- Amadeo by Tyromotion, Active Learning Protocol for Stroke
- 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
- Medical subject headings
- Paresis, Cerebral Palsy, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amadeo by TyromotionDevice
Distal upper extremity/hand robot for robot-assisted therapy
Active Learning Protocol for StrokeBehavioural
Also called ALPS
Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Amadeo by Tyromotion; Behavioral: Active Learning Protocol for Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Recruitment
Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained?
Measured: 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?
Measured: 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.
Measured: Determined at the conclusion of the study, approximately 2 years
Staff's Perceived Competency of Hemiparesis
Measured by a post-training survey.
Measured: Determined at the conclusion of the study, approximately 2 years
Staff's Actual Competency of Hemiparesis
Measured by routine audits.
Measured: Every 3 months until conclusion of the study, up to 2 years
Staff's Perceived Competency of Amadeo
Measured by post-training survey.
Measured: Determined at the conclusion of the study, approximately 2 years
Staff's Actual Competency of Amadeo
Measured by routine audits.
Measured: Every 3 months until conclusion of the study, up to 2 years
Staff's Actual Competency of Amadeo
Measured by fidelity checklist.
Measured: Determined at the conclusion of the study, approximately 2 years
Staff's Perceived Competency of ALPS
Measured by post-training survey.
Measured: Determined at the conclusion of the study, approximately 2 years
Staff's Actual Competency of ALPS
Measured by routine audits.
Measured: Every 3 months until conclusion of the study, up to 2 years
Staff's Actual Competency of ALPS
Measured by fidelity checklist.
Measured: Determined at the conclusion of the study, approximately 2 years
Secondary outcomes (5)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start11 Jan 2021
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MGH Institute of Health Professions
- Responsible party
- Principal investigator, Casey Rabideau, Boston Children's Hospital
- Investigators
- Casey Rabideau, MS, OTR, BCP, Principal investigator, Department of Physical and Occupational Therapy Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309266
- Sponsor's protocol ID
- IRB P00032628
- Status last verified
- Dec 2023
- First submitted
- 4 Mar 2020
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Robot Assisted Therapy and Metacognitive Skills Training on Functional Performance for Children With Hemiparesis: A Pilot Study
- ClinicalTrials.gov ID
- NCT04309266
- Acronym / sponsor ID
- IRB P00032628
- Keywords
- arm weakness, cerebral palsy, stroke, in utero, cognition, occupational therapy, robot therapy, robot assisted therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- MGH Institute of Health Professions
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Therapy with Metacognitive Skills Training | Experimental | Device: Amadeo by Tyromotion, Behavioral: Active Learning Protocol for StrokeAll participants will be enrolled in the single arm of this study, where they will receive robot assisted therapy combined with metacognitive skills training. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amadeo by TyromotionDistal upper extremity/hand robot for robot-assisted therapy | Device | Robot Assisted Therapy with Metacognitive Skills Training |
| Active Learning Protocol for StrokeAlso: ALPSMetacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program. | Behavioural | Robot Assisted Therapy with Metacognitive Skills Training |
Primary outcome
Patient Recruitment
Time frame: Determined at the conclusion of the study, approximately 2 years
Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained?
Implementation of Intervention
Time frame: Determined at the conclusion of the study, approximately 2 years
Was the recommended frequency/duration of Amadeo and ALPS provided to participants?
Implementation of Intervention
Time frame: Determined at the conclusion of the study, approximately 2 years
Did patients adhere to daily home programming? - At least 80% compliance will be deemed successful.
Staff's Perceived Competency of Hemiparesis
Time frame: Determined at the conclusion of the study, approximately 2 years
Measured by a post-training survey.
Staff's Actual Competency of Hemiparesis
Time frame: Every 3 months until conclusion of the study, up to 2 years
Measured by routine audits.
Staff's Perceived Competency of Amadeo
Time frame: Determined at the conclusion of the study, approximately 2 years
Measured by post-training survey.
Staff's Actual Competency of Amadeo
Time frame: Every 3 months until conclusion of the study, up to 2 years
Measured by routine audits.
Staff's Actual Competency of Amadeo
Time frame: Determined at the conclusion of the study, approximately 2 years
Measured by fidelity checklist.
Staff's Perceived Competency of ALPS
Time frame: Determined at the conclusion of the study, approximately 2 years
Measured by post-training survey.
Staff's Actual Competency of ALPS
Time frame: Every 3 months until conclusion of the study, up to 2 years
Measured by routine audits.
Staff's Actual Competency of ALPS
Time frame: Determined at the conclusion of the study, approximately 2 years
Measured by fidelity checklist.
5 secondary outcomes
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).
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Hemiparesis
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Telerehabilitation for Post-Stroke Hand Function
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Kinematic Analysis of Manual Dexterity
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casey Rabideau, MS, OTR, BCP principal investigator
Department of Physical and Occupational Therapy Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amadeo by Tyromotion and Active Learning Protocol for Stroke in people with Hemiparesis and Hemiplegic Cerebral Palsy, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Recruitment (time frame: Determined at the conclusion of the study, approximately 2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.