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Rehabilitation Robotics, Cognitive Skills Training and Function

NCT ID: NCT03599544

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2020-03-03

Brief Summary

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This study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. Half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.

Detailed Description

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Research has shown that robot-assisted therapy can help people regain control of simple reaching or grasping movements, but these improvements don't generalize well to use of the weaker limb during everyday tasks.

This study aims to refine and test a protocol named the Active Learning Program for Stroke (ALPS), which teaches people to use active problem solving strategies and a home program to improve function. Therapist-delivered ALPS instruction may incorporate use of strategies (e.g. STOP, THINK, DO, CHECK) modeled after the Cognitive Orientation for daily Occupational Performance (CO-OP) approach to improve real-world use of the paretic upper limb. We will evaluate whether the combination of robot-assisted therapy and ALPS training leads to better satisfaction and functional use of the weaker arm in persons with motor impairments more than 6 months after stroke, as compared to robot-assisted therapy alone.

Conditions

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Stroke Cerebrovascular Accident

Keywords

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Upper limb function Arm and hand weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Evaluator(s) will be blinded to assigned study group and intervention.

Study Groups

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Robot-Assisted Therapy (RT)

Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks.

Group Type ACTIVE_COMPARATOR

Robot-Assisted Therapy (RT)

Intervention Type BEHAVIORAL

Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks).

Robot + Active Learning Program(RT-ALPS)

Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks plus training in active problem solving, analysis of performance, and goal-setting focused on the transfer of acquired motor skills to daily activities in the home and community.

Group Type EXPERIMENTAL

Robot + Active Learning Program(RT-ALPS)

Intervention Type BEHAVIORAL

Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks). In addition, participants will receive training in active problem solving, analysis of performance and goal setting focused on home action plan activities to assist with carry-over and generalization to every day activities.

Interventions

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Robot-Assisted Therapy (RT)

Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks).

Intervention Type BEHAVIORAL

Robot + Active Learning Program(RT-ALPS)

Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks). In addition, participants will receive training in active problem solving, analysis of performance and goal setting focused on home action plan activities to assist with carry-over and generalization to every day activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with unilateral stroke more than 6 months prior to study enrollment.
* Stroke type will include both ischemic and hemorrhagic stroke.
* Moderate UE hemiparesis (characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA) between 19-47/60)
* Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score \>/=26/30)during the initial evaluation visit

Exclusion Criteria

* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy, as indicated by subtests of the Fugl-Meyer Assessment (FMA) \[13\]
* Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale \[15\];
* Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test \[16\]
* Aphasia sufficient to limit comprehension and completion of the treatment protocol
* Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
* Treatment with Botox injections for the affected arm within the previous 4 months or planned Botox injections before the end of the study
* Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Occupational Therapy Foundation

OTHER

Sponsor Role collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susan Fasoli, ScD OTR/L

Associate Professor, MGH Institute of Health Professions

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Bonato, PhD

Role: STUDY_CHAIR

Spaulding Rehabilitation Hospital

Locations

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MGH Institute of Health Professions

Boston, Massachusetts, United States

Site Status

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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AOTFIRG18FASOLI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2018P001182

Identifier Type: -

Identifier Source: org_study_id