Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MGH Institute of Health Professions | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amadeo by Tyromotion | Device | Distal upper extremity/hand robot for robot-assisted therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Recruitment | Quantitative tracking of patient recruitment - was the goal n of 15 children with hemiparesis who completed the study attained? | 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? | 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. | Determined at the conclusion of the study, approximately 2 years |
| Staff's Perceived Competency of Hemiparesis | Measured by a post-training survey. | Determined at the conclusion of the study, approximately 2 years |
| Staff's Actual Competency of Hemiparesis | Measured by routine audits. | Every 3 months until conclusion of the study, up to 2 years |
| Staff's Perceived Competency of Amadeo | Measured by post-training survey. | Determined at the conclusion of the study, approximately 2 years |
| Staff's Actual Competency of Amadeo | Measured by routine audits. | Every 3 months until conclusion of the study, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Upper Extremity Full Version |
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Casey Rabideau, MS, OTR, BCP | Department of Physical and Occupational Therapy Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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.
Present (3/2020) - until study write-up is prepared for publishing (anticipated fall 2022).
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010291 | Paresis |
| D002547 | Cerebral Palsy |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Learning Protocol for Stroke | Behavioral | Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program. |
|
|
| Staff's Actual Competency of Amadeo | Measured by fidelity checklist. | Determined at the conclusion of the study, approximately 2 years |
| Staff's Perceived Competency of ALPS | Measured by post-training survey. | Determined at the conclusion of the study, approximately 2 years |
| Staff's Actual Competency of ALPS | Measured by routine audits. | Every 3 months until conclusion of the study, up to 2 years |
| Staff's Actual Competency of ALPS | Measured by fidelity checklist. | Determined at the conclusion of the study, approximately 2 years |
| 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 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 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 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 at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| Quality of Upper Extremity Skills Test (QUEST) |
| Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| Shriner's Hospital Upper Extremity Evaluation (SHUEE) |
| Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| Pain Scale |
| Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| Stereognosis Sensory Testing |
| Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| Two-Point Discrimination Sensory Testing |
| Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| Active and Passive Range of Motion |
| Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10). |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |