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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07000019
Acronym
CARAT
Enrollment
28
Registered
2025-05-31
Start date
2025-06-30
Completion date
2027-11-30
Last updated
2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia Following Cerebral Infarction, Hemiparesis After Stroke, Stroke

Keywords

stroke, aphasia, hemiparesis, robotic

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.

Interventions

BEHAVIORALCARAT: 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.

BEHAVIORALRobot-assisted arm therapy

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

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
New York University
CollaboratorOTHER
New York Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Philadelphia Naming TestBaseline to 1 week post-treatment
Fugl-Meyer Upper Extremity Motor AssessmentBaseline to 1 week post-treatment

Secondary

MeasureTime frame
Apraxia Battery for AdultsBaseline to 1 and 4 weeks post-training
Stroke and Aphasia Quality of Life Scale-39Baseline to 1 and 4 weeks post-training
Apraxia of Speech Rating ScaleBaseline to 1 and 4 weeks post-training
Western Aphasia Battery-Revised Aphasia QuotientBaseline to 4 weeks post-treatment
Box and Blocks TestBaseline to 1 and 4 weeks post-training

Other

MeasureTime frame
Arm kinematicsBaseline to 1 and 4 weeks post-training
Arm vs. Non-Arm NamingBaseline to 1 and 4 weeks post-training

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026