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Active Learning Protocol for Stroke for Hemiparesis

N/A
Waitlist Available
Led By Casey Rabideau, MS, OTR, BCP
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child must have hemiparesis caused by cerebral vascular accident.
Child must have hemiparesis with at least partial active grasp and release.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up determined at the conclusion of the study, approximately 2 years
Awards & highlights

Study Summary

This trial will explore the benefits of using robot assisted therapy and a problem solving approach to help children with hemiparesis make gains in hand/arm skills and everyday activities.

Who is the study for?
This trial is for children aged 7-17 with hemiparesis, able to grasp and follow commands. They must speak English, have a caregiver to help at home, and insurance coverage for the study's costs. It excludes those who don't meet these criteria.Check my eligibility
What is being tested?
The trial tests robot-assisted therapy (Amadeo) combined with problem-solving training (Active Learning Program for Stroke) in improving hand/arm skills and daily activities in children with hemiparesis.See study design
What are the potential side effects?
Potential side effects are not explicitly mentioned but may include typical reactions to physical therapy such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The child must have weakness on one side of the body caused by a stroke.
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The child must be able to use at least part of their hand to grab and release objects.
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The child needs to be able to understand and do more than one thing at a time when asked.
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A parent or guardian must be available to help the child with their home exercise program.
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The child needs to be able to speak English.
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You need to have insurance that will pay for the medical tests and treatments needed for this study.
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The child must be between 7 and 17 years old when the study begins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~determined at the conclusion of the study, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and determined at the conclusion of the study, approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implementation of Intervention
Patient Recruitment
Staff's Actual Competency of ALPS
+5 more
Secondary outcome measures
9 Hole Peg Test
Box & Blocks
Canadian Occupational Performance Measure (COPM)
+2 more
Other outcome measures
Active and Passive Range of Motion
Pain Scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Upper Extremity Full Version
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Robot Assisted Therapy with Metacognitive Skills TrainingExperimental Treatment2 Interventions
All participants will be enrolled in the single arm of this study, where they will receive robot assisted therapy combined with metacognitive skills training.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,728 Total Patients Enrolled
MGH Institute of Health ProfessionsOTHER
15 Previous Clinical Trials
3,653 Total Patients Enrolled
Casey Rabideau, MS, OTR, BCPPrincipal InvestigatorDepartment of Physical and Occupational Therapy Service

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians admissible for involvement in this research project?

"For this research, only children aged 7 to 17 are eligible for enrollment. In total, there are 145 trials accepting minors and 91 enrolling seniors as participants."

Answered by AI

Who qualifies to participate in this medical research?

"This clinical trial requires prospective participants to have hemiparesis and be aged between 7-17 years old. There are only 2 vacancies available for this medical study."

Answered by AI

Are there any vacant spots available for volunteers in this research?

"The clinicaltrials.gov registry records that this experiment is not actively enrolling patients at the moment, with its initial posting on November 1st 2021 and most recent update taken place a year later. Nevertheless, 222 other studies are currently open to participants."

Answered by AI

What are the aims of this trial's research protocol?

"The primary objective of this 2-year long study is to recruit participants. The Canadian Occupational Performance Measure (COPM) will be administered, allowing both the parent/caregiver and child to collaboratively develop goal priority areas as well as score their performance and satisfaction in each area individually. Scores are ranked on a scale from 1-10 with higher scores signifying stronger self-perceived performance or satisfaction. In addition, the 9 Hole Peg Test and Jebsen Hand Function Test will also be given; these tests measure fine manual dexterity and uni-manual skills required for daily activities respectively. Each test has an administration"

Answered by AI
~0 spots leftby Apr 2025