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NCT Number: NCT07000019

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

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.

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Key information

Conditions

Stroke Aphasia Aphasia Following Cerebral Infarction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Hemiparesis After Stroke Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westchester Medical Center / New York Medical College

Valhalla, New York, 10595, United States

Location contact

Cristina Falo, PhD

CONTACT

[email protected]

Tomoko Kitago, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CARAT: combined aphasia and robot-assisted arm therapy

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 therapy

Behavioral

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

Primary outcomes

  1. Philadelphia Naming Test

    Time frame: Baseline to 1 week post-treatment

  2. Fugl-Meyer Upper Extremity Motor Assessment

    Time frame: Baseline to 1 week post-treatment

Secondary outcomes

  1. Western Aphasia Battery-Revised Aphasia Quotient

    Time frame: Baseline to 4 weeks post-treatment

  2. Box and Blocks Test

    Time frame: Baseline to 1 and 4 weeks post-training

  3. Apraxia Battery for Adults

    Time frame: Baseline to 1 and 4 weeks post-training

  4. Stroke and Aphasia Quality of Life Scale-39

    Time frame: Baseline to 1 and 4 weeks post-training

  5. Apraxia of Speech Rating Scale

    Time frame: Baseline to 1 and 4 weeks post-training

Other outcomes

  1. Arm kinematics

    Time frame: Baseline to 1 and 4 weeks post-training

  2. Arm vs. Non-Arm Naming

    Time frame: Baseline to 1 and 4 weeks post-training

Sponsors and collaborators

Lead sponsor

New York Medical College

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • New York University

Registry information

Acronym: CARAT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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