StrokeCARATNCT07000019
Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors
A study testing CARAT: combined aphasia and robot-assisted arm therapy and Robot-assisted arm therapy in people with Stroke and Aphasia Following Cerebral Infarction, run by New York Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Aphasia Following Cerebral Infarction, Hemiparesis After Stroke
- What is being tested?
- CARAT: combined aphasia and robot-assisted arm therapy and Robot-assisted arm therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Westchester Medical Center / New York Medical College
Valhalla, New York, 10595
Cristina Falo, PhD, cristina.falo@wmchealth.org
Tomoko Kitago, MD
About this study
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.
- Being tested
- CARAT: combined aphasia and robot-assisted arm therapy, Robot-assisted arm therapy
- Keywords
- stroke, aphasia, hemiparesis, robotic
- Medical subject headings
- Stroke, Aphasia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARAT: combined aphasia and robot-assisted arm therapyBehavioural
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 therapyBehavioural
Participants will receive 18 sessions of robot-assisted arm therapy with the goal of improving arm movements.
| Study group | Role | What they receive |
|---|---|---|
| Combined aphasia and robot-assisted arm treatment | Experimental | Not described Receives: Behavioral: CARAT: combined aphasia and robot-assisted arm therapy |
| Robot-assisted arm treatment | Active comparator | Not described Receives: Behavioral: Robot-assisted arm therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Philadelphia Naming Test
Measured: Baseline to 1 week post-treatment
Fugl-Meyer Upper Extremity Motor Assessment
Measured: Baseline to 1 week post-treatment
Secondary outcomes (5)
Western Aphasia Battery-Revised Aphasia Quotient
Measured: Baseline to 4 weeks post-treatment
Box and Blocks Test
Measured: Baseline to 1 and 4 weeks post-training
Apraxia Battery for Adults
Measured: Baseline to 1 and 4 weeks post-training
Stroke and Aphasia Quality of Life Scale-39
Measured: Baseline to 1 and 4 weeks post-training
Apraxia of Speech Rating Scale
Measured: Baseline to 1 and 4 weeks post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study startJun 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), New York University
- Responsible party
- Principal investigator, Tomoko Kitago, MD, New York Medical College
- Investigators
- Tomoko Kitago, MD, Principal investigator, Westchester Medical Center / New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000019
- Sponsor's protocol ID
- NYMC-25470
- Other IDs
- R21DC019955
- Acronym
- CARAT
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT07000019
- Acronym / sponsor ID
- CARAT / NYMC-25470
- Keywords
- stroke, aphasia, hemiparesis, robotic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), New York University
- Study start
- Jun 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARAT: combined aphasia and robot-assisted arm therapyParticipants 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. | Behavioural | Combined aphasia and robot-assisted arm treatment |
| Robot-assisted arm therapyParticipants will receive 18 sessions of robot-assisted arm therapy with the goal of improving arm movements. | Behavioural | Robot-assisted arm treatment |
Primary outcome
Philadelphia Naming Test
Time frame: Baseline to 1 week post-treatment
Fugl-Meyer Upper Extremity Motor Assessment
Time frame: Baseline to 1 week post-treatment
5 secondary outcomes
Western Aphasia Battery-Revised Aphasia Quotient
Time frame: Baseline to 4 weeks post-treatment
Box and Blocks Test
Time frame: Baseline to 1 and 4 weeks post-training
Apraxia Battery for Adults
Time frame: Baseline to 1 and 4 weeks post-training
Stroke and Aphasia Quality of Life Scale-39
Time frame: Baseline to 1 and 4 weeks post-training
Apraxia of Speech Rating Scale
Time frame: Baseline to 1 and 4 weeks post-training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Westchester Medical Center / New York Medical College
Valhalla, United States
Tomoko Kitago, MD principal investigator
Westchester Medical Center / New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARAT: combined aphasia and robot-assisted arm therapy and Robot-assisted arm therapy in people with Stroke and Aphasia Following Cerebral Infarction, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Philadelphia Naming Test (time frame: Baseline to 1 week post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.