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

NCT07000019 | Not Yet Recruiting

• 2 other identifiers: NYMC-25470R21DC019955
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Aphasia Following Cerebral Infarction; Hemiparesis After Stroke

Keywords

stroke, aphasia, hemiparesis, robotic

Outcome Measures

Primary Outcomes (2)

• Philadelphia Naming Test

  Baseline to 1 week post-treatment

• Fugl-Meyer Upper Extremity Motor Assessment

  Baseline to 1 week post-treatment

Secondary Outcomes (5)

• Western Aphasia Battery-Revised Aphasia Quotient

  Baseline to 4 weeks post-treatment

• Box and Blocks Test

  Baseline to 1 and 4 weeks post-training

• Apraxia Battery for Adults

  Baseline to 1 and 4 weeks post-training

• Stroke and Aphasia Quality of Life Scale-39

  Baseline to 1 and 4 weeks post-training

• Apraxia of Speech Rating Scale

  Baseline to 1 and 4 weeks post-training

Other Outcomes (2)

• Arm kinematics

  Baseline to 1 and 4 weeks post-training

• Arm vs. Non-Arm Naming

  Baseline to 1 and 4 weeks post-training

Study Arms (2)

Combined aphasia and robot-assisted arm treatment

EXPERIMENTAL

Behavioral: CARAT: combined aphasia and robot-assisted arm therapy

Robot-assisted arm treatment

ACTIVE COMPARATOR

Behavioral: Robot-assisted arm therapy

Interventions

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.

Combined aphasia and robot-assisted arm treatment

Robot-assisted arm therapy BEHAVIORAL

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

Robot-assisted arm treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Medical College: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• New York University: collaborator

Study Sites (1)

Westchester Medical Center / New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Stroke; Aphasia; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomoko Kitago, MD

  Westchester Medical Center / New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)