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

Hemiparesis Clinical Trial

Official title:

Understanding the Impact of Robot Assisted Therapy and Metacognitive Skills Training on Functional Performance for Children With Hemiparesis: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04309266
• Other study ID #: IRB P00032628
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: January 2024

Study information

• Verified date: December 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiparesis
• Hemiparesis;Poststroke/CVA
• Hemiplegic Cerebral Palsy
• Paresis

Intervention

Device:
• Amadeo by Tyromotion
Distal upper extremity/hand robot for robot-assisted therapy

Behavioral:
• Active Learning Protocol for Stroke
Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	MGH Institute of Health Professions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Upper Extremity Full Version	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	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Other	Quality of Upper Extremity Skills Test (QUEST)	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.	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Other	Shriner's Hospital Upper Extremity Evaluation (SHUEE)	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	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Other	Pain Scale	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	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Other	Stereognosis Sensory Testing	All participants evaluated; Measures child's ability to perceive and recognize an object in hand. Scored in percentile correct.	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Other	Two-Point Discrimination Sensory Testing	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.	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Other	Active and Passive Range of Motion	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.	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Primary	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
Primary	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
Primary	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
Primary	Staff's Perceived Competency of Hemiparesis	Measured by a post-training survey.	Determined at the conclusion of the study, approximately 2 years
Primary	Staff's Actual Competency of Hemiparesis	Measured by routine audits.	Every 3 months until conclusion of the study, up to 2 years
Primary	Staff's Perceived Competency of Amadeo	Measured by post-training survey.	Determined at the conclusion of the study, approximately 2 years
Primary	Staff's Actual Competency of Amadeo	Measured by routine audits.	Every 3 months until conclusion of the study, up to 2 years
Primary	Staff's Actual Competency of Amadeo	Measured by fidelity checklist.	Determined at the conclusion of the study, approximately 2 years
Primary	Staff's Perceived Competency of ALPS	Measured by post-training survey.	Determined at the conclusion of the study, approximately 2 years
Primary	Staff's Actual Competency of ALPS	Measured by routine audits.	Every 3 months until conclusion of the study, up to 2 years
Primary	Staff's Actual Competency of ALPS	Measured by fidelity checklist.	Determined at the conclusion of the study, approximately 2 years
Secondary	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	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Secondary	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.	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Secondary	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	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Secondary	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	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).
Secondary	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	Administered at week 1, week 10 of protocol (after completing 8 weeks of the intervention), and week 14 (1 month after week 10).