UnknownNot Applicable

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

United States2 participantsStarted 2021-01-11

Plain-language 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.

Who can participate

Age range

7 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Recruitment

Timeframe: Determined at the conclusion of the study, approximately 2 years

Implementation of Intervention

Timeframe: Determined at the conclusion of the study, approximately 2 years

Implementation of Intervention

Timeframe: Determined at the conclusion of the study, approximately 2 years

Staff's Perceived Competency of Hemiparesis

Timeframe: Determined at the conclusion of the study, approximately 2 years

Staff's Actual Competency of Hemiparesis

Timeframe: Every 3 months until conclusion of the study, up to 2 years

Staff's Perceived Competency of Amadeo

Timeframe: Determined at the conclusion of the study, approximately 2 years

Staff's Actual Competency of Amadeo

Timeframe: Every 3 months until conclusion of the study, up to 2 years

Trial details

NCT IDNCT04309266

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Hemiparesis trials

Plain-language summary

Who can participate

Age range

7 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient Recruitment

Timeframe: Determined at the conclusion of the study, approximately 2 years

Implementation of Intervention

Timeframe: Determined at the conclusion of the study, approximately 2 years

Implementation of Intervention

Timeframe: Determined at the conclusion of the study, approximately 2 years

Staff's Perceived Competency of Hemiparesis

Timeframe: Determined at the conclusion of the study, approximately 2 years

Staff's Actual Competency of Hemiparesis

Timeframe: Every 3 months until conclusion of the study, up to 2 years

Staff's Perceived Competency of Amadeo

Timeframe: Determined at the conclusion of the study, approximately 2 years

Staff's Actual Competency of Amadeo

Timeframe: Every 3 months until conclusion of the study, up to 2 years