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

New York Medical College

Status: Not yet enrolling

Conditions: Stroke; Hemiparesis After Stroke; Aphasia Following Cerebral Infarction

Treatments: Behavioral: CARAT: combined aphasia and robot-assisted arm therapy; Behavioral: Robot-assisted arm therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07000019

NYMC-25470

R21DC019955 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Combined aphasia and robot-assisted arm treatment

Experimental group

Treatment:

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

Robot-assisted arm treatment

Active Comparator group

Treatment:

Behavioral: Robot-assisted arm therapy