Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors

NCT ID: NCT07000019

Last Updated: 2025-05-31

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-11-30

Brief Summary

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The goal of this clinical trial is to learn if a program that combines language and arm treatment can improve language and movement problems in people with chronic stroke. The mains questions it aims to answer are:

* To determine the extent to which this combined treatment can improve language.
* To determine the extent to which the combined treatment can improve arm movements.

Researchers will compare the effects of this combined treatment with treatment that targets arm movements alone.

Detailed Description

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Conditions

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Stroke Aphasia Following Cerebral Infarction Hemiparesis After Stroke

Keywords

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stroke, aphasia, hemiparesis, robotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combined aphasia and robot-assisted arm treatment

Group Type EXPERIMENTAL

CARAT: combined aphasia and robot-assisted arm therapy

Intervention Type BEHAVIORAL

Participants will receive 18 sessions of robot-assisted arm therapy combined with a standardized picture-word verification therapy task with the goal of improving language and arm movements.

Robot-assisted arm treatment

Group Type ACTIVE_COMPARATOR

Robot-assisted arm therapy

Intervention Type BEHAVIORAL

Participants will receive 18 sessions of robot-assisted arm therapy with the goal of improving arm movements.

Interventions

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CARAT: combined aphasia and robot-assisted arm therapy

Participants will receive 18 sessions of robot-assisted arm therapy combined with a standardized picture-word verification therapy task with the goal of improving language and arm movements.

Intervention Type BEHAVIORAL

Robot-assisted arm therapy

Participants will receive 18 sessions of robot-assisted arm therapy with the goal of improving arm movements.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients between 18-90 years of age.
2. Right-handed prior to stroke
3. English-speaking (monolingual)
4. History of single left-hemisphere stroke at least 6 months prior to enrollment
5. Presence of aphasia and naming deficits on Western Aphasia Battery (WAB-R)
6. Comprehension score above 4 on WAB-R
7. Unilateral upper limb paresis (Fugl-Meyer Upper Extremity score \<56)
8. Documentation of signed Informed Consent by the study participant.

Exclusion Criteria

1. Diagnosis or history of speech impairment prior to stroke
2. Severely limited speech output (score below 2 on spontaneous speech portion of WAB-R)
3. Inability to perform screening tasks due to severe language and/or cognitive impairment
4. Condition limiting passive movement in the range of motion required for robotic therapy (e.g. fixed contracture)
5. Any medical or psychiatric condition that may impact participation or compliance with study procedures or activities in the opinion of the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Medical College

OTHER

Sponsor Role lead

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

Responsible Party

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Tomoko Kitago, MD

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomoko Kitago, MD

Role: PRINCIPAL_INVESTIGATOR

Westchester Medical Center / New York Medical College

Locations

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Westchester Medical Center / New York Medical College

Valhalla, New York, United States

Site Status

Countries

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United States

Facility Contacts

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Cristina Falo, PhD

Role: primary

Other Identifiers

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R21DC019955

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NYMC-25470

Identifier Type: -

Identifier Source: org_study_id